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Decentralized Clinical Trials and Contract Research Organizations in 2023

Decentralized Clinical Trials for the CRO

Decentralized clinical trials (DCTs) are a relatively new concept in the world of clinical research, but they are quickly becoming more popular. In 2023, DCTs are expected to become even more widely used as the technology and infrastructure needed to support them continues to develop.

A decentralized clinical trial is one that is centered around patient needs and improves the patient experience by allowing them to participate from their own homes or local healthcare providers. This type of trial eliminates the need for patients to physically access hospital-based trial sites, which can be difficult for some people due to distance or other factors. It also allows for greater flexibility in terms of scheduling and data collection, as well as improved accuracy of results due to fewer potential sources of error.

In addition to these guidelines from the FDA, there are several ethical considerations that must be taken into account when conducting a decentralized clinical trial. These include ensuring patient privacy and confidentiality, providing informed consent forms that clearly explain the risks associated with participating in a DCT, and ensuring that all participants have access to appropriate medical care if needed during the course of the study.

How CROS can Implement DCTs

Contract research organizations (CROs) can implement decentralized clinical trials by modifying their protocol to incorporate remote data collection, patient-centric protocols, and virtual engagement between trial participants and CRO personnel. Remote data collection allows for the capture of participant-generated data outside of a traditional clinical setting via digital devices. Patient-centric protocols allow for a more personal approach to clinical trials by allowing patients to participate in activities such as self-reporting on symptom severity, digitally submitting medical images and lab results, and engaging with physicians from the comfort of their own home. Virtual engagement between trial participants and CRO personnel can be facilitated through secure video conferencing tools that enable real-time interactions.

Further modifications to the CRO protocols could also include integrating artificial intelligence technology into the trial process such as automated monitoring of patient behavior, prioritizations of interventions based on individual risk profiles, and remote health guidance by virtual nurses or other healthcare professionals. Mobile applications could also be used to remind participants about upcoming appointments or events related to the study as well as remind them about taking medication or completing questionnaires. Incorporating these types of technologies would ensure that decentralized clinical trials are conducted efficiently while providing participants with an enhanced user experience throughout every step of the trial process.

Five Steps to Implementing Decentralized Clinical Trials

1.Educate Project Managers: Contract research organizations (CROs) should ensure that their project managers are educated about the benefits of decentralized clinical trials and how to go about implementing them. This could include learning about the technology, regulations, data privacy, and other important elements related to this type of trial design.

2. Establish Data Security Measures: Before conducting a decentralized clinical trial, CROs should have strong data security measures in place to protect participants’ information and ensure that it is secure throughout the study duration. This includes accessing participant data only with permission and using encryption protocols when transmitting or storing any sensitive information.

3.Evaluate eClinical Platforms: A key part of implementing decentralized clinical trials is choosing the right eClinical platform for your study design. CROs should evaluate the various eClinical platforms available to them and select one that meets their needs for a successful trial, such as being user friendly for participants, having features such as remote monitoring capabilities, offering robust reporting capabilities, and providing easy access to data from multiple sites.

4.Utilize Mobile Technologies: To make a decentralized clinical trial successful, leveraging mobile technologies can be extremely helpful for CROs to communicate with volunteers remotely, manage participant engagement in real-time, collect patient-reported outcomes quickly and accurately from anywhere, track compliance with protocols on site visits or assessments done remotely, etc., reducing the need for face-to-face visits whenever possible.

5. Create Protocols: Having clear protocols in place is essential if a CRO wants to successfully implement decentralized clinical trials as they help ensure consistency across different sites by setting expectations around communication between sites and central teams; supervision of staff; quality control procedures; safety reporting; use of investigational drugs; collection of patient data; follow up on withdrawals or lost patients; etc., throughout the duration of the trial

How do DCTs Work?

Decentralized clinical trials offer a variety of benefits to CROs, such as reduced costs associated with traditional on-site trials, improved patient recruitment, faster data collection and analysis, and greater efficiency.

Decentralized clinical trials (DCTs) offer a promising new model for contract research organizations (CROs). By leveraging decentralized technologies such as blockchain and distributed ledger technology, DCTs provide a secure, efficient, and cost-effective alternative to traditional CRO models.

The key advantages of DCTs for CROs include enhanced security and data integrity, improved consent management, faster and more secure patient recruitment, and greater visibility into the trial process. With DCTs, CROs can leverage existing research infrastructure while streamlining processes such as data management and quality control.

To further explore the potential of DCTs, it's helpful to look at some recent developments in the industry. In 2018, Decentralized Clinical Trials LLC partnered with Johnson & Johnson to create JLABS@TMCx to develop innovative digital health solutions for clinical trials. This collaboration unveiled two major projects that leverage decentralized technologies: Project Catalyst and Project Ovenbird.

Project Catalyst seeks to develop a system of protocols that will allow researchers to securely exchange information in real-time. The project is currently focused on developing decentralized application (dApp) versions of standard protocols and applications used in clinical trials. Meanwhile, Project Ovenbird seeks to create an enterprise-grade distributed data platform that will enable researchers to collect structured data from decentralized sources while maintaining privacy standards comparable to those set by HIPAA.

In addition to these projects with J&J, Decentralized Clinical Trials LLC has also partnered with Microsoft Corporation on a pilot program called "Verified Credentials." This program leverages blockchain technology to ensure accurate identity verification during patient recruitment processes for clinical trials.

For CROs interested in exploring DCTs further, there are several resources available online that can help provide a better understanding of their benefits, applications, and potential challenges. The National Institutes of Health recently launched the Decentralized Clinical Trials Hub (DCThub), which provides educational materials about DCTs for research professionals. Additionally, several companies offer products tailored specifically for DCTs such as TrialX from OptumIQ or Oneyield from Castor EDC Solutions Ltd., both of which are designed to support decentralized clinical trial design and implementation workflows.

Types of Remote Monitoring in DCTs

Decentralized clinical trials are conducted using remote monitoring technology to capture data from patients rather than requiring them to come into a physical research site. This allows for more flexible trial designs that can be tailored to specific patient populations and geographic locations. In addition, patients can more easily participate in a trial without having to travel or take time off from their daily lives. For example, virtual visits through telemedicine can be used for initial screening and assessments, reducing the number of visits required at an on-site research facility.

Data collected from decentralized clinical trials is often more accurate than what is typically collected in traditional on-site trials due to the use of continuous wearables, mobile devices and other innovative digital technologies that provide real-time monitoring of health parameters such as blood pressure or glucose levels. This increases the quality and granularity of information available to researchers while decreasing the amount of labor required for data collection. Additionally, electronic health records (EHRs) can be integrated with decentralized trial platforms allowing for rich longitudinal datasets that enable deeper insights into patient outcomes over time.

One example of a decentralized clinical trial is the use of telemedicine to support remote monitoring. This could involve providing video conferencing for patient-physician visits and using smartphones for tracking vital signs. In addition, telemedicine can enable doctors to monitor patients with chronic conditions remotely, by collecting medical data from sensors that have been placed on the patient’s body. This type of monitoring allows doctors to keep track of changes in health parameters without requiring an in-person visit, significantly reducing both costs and risks associated with traveling for treatment.

Another example is direct-to-patient (DTP) trials, in which medication is shipped directly to a patient's home instead of them having to travel to a clinic. In this case, study coordinators can monitor the progress remotely via phone calls or text messages while also providing support when needed. This approach has enabled researchers to conduct studies involving large numbers of participants located around the world who would otherwise not have been able to participate due to geographic distance or lack of transportation resources.

Finally, wearable devices are also being used increasingly in decentralized clinical trials as they allow researchers to collect more accurate data about activity levels and other health metrics over long periods of time without needing frequent interventions from healthcare personnel. It is possible for these devices to be connected directly with electronic data capture systems so that the collected information can be analyzed quickly and accurately by researchers.

Larger Patient Engagement

The decentralization of clinical research also opens up new opportunities for CROs to reach larger populations by enabling simultaneous studies across multiple sites around the world and removing many logistical barriers related to travel or geographical distance between participants and study sites. Additionally, leveraging social media platforms for recruiting further expands access potential outside of traditional recruitment networks and offers ways to engage with potential participants more directly than before.

Decentralized clinical trials, also called virtual studies or remote research, have the potential to revolutionize the way clinical studies are conducted. A decentralized clinical trial is a type of clinical study where participants are distributed across geographical and other boundaries, allowing them to participate from their own homes or from one of many remote sites.

To explore further options regarding DCTs and related technologies, interested parties may consult companies such as Medidata Solutions (www.medidatasolutionsinc.com), IMS Health (www.imshealth.com), HRA Pharma (www.hrapharma) or IQVIA (www.iqvia). These firms specialize in providing comprehensive services related to DCT implementation, ranging from development and customization of software solutions through full project management services that cover all aspects of a clinical trial operation from start-up through completion – including training protocols for implementing these new technologies at each site visited during study duration and beyond..

Overall, decentralized clinical trials represent a significant opportunity for CROs looking to move away from costly on-site studies in favor of more cost effective approaches that offer equally robust data sets but require fewer resources from both researchers and participants alike. As technology continues to advance so too will our collective ability to take advantage of decentralized trial designs for bigger impact studies without sacrificing quality or rigor.

Decentralized clinical trials offer many advantages over traditional site-based studies. They provide greater convenience for patients while still maintaining high levels of safety and efficacy standards. As technology continues to advance in 2023, we can expect even more opportunities for DCTs to become available.

More Examples on Decentralized Clinical Trials:

In the past decade, the advent of blockchain and other technologies have made it possible for clinical trials to be conducted in a decentralized manner. Here are five examples of decentralized clinical trials currently taking place across the world.

1. Mediledger Clinical Trial Supply Chain: This trial is being managed by MediLedger, a healthcare-focused blockchain consortium. The goal of this trial is to use blockchain technology to streamline and secure the global movement and tracking of drugs within the supply chain. The solution will enable parties to share data about patient safety, drug expiration dates, and more in real-time – all while remaining compliant with regulatory standards.

2. CardiLynx Smart Phone ECG Readings: This study is being conducted by CardiLynx, a healthcare technology company that specializes in mobile health applications that measure electrocardiograms (ECGs). The aim of this trial is to use an app on a smartphone to accurately detect heart arrhythmias in patients over time, as well as identify early symptoms and risk factors associated with cardiovascular diseases like stroke and heart attack.

3. Cogstate Cognitive Testing Trial: This study is sponsored by Cogstate, an AI-powered cognitive assessment platform that uses computer games to measure cognitive performance across multiple disciplines such as memory, attention and executive functioning. The purpose of this trial is to evaluate how well Cogstate’s technology can accurately detect changes in cognition over time in various patient populations and disease states.

4. Takeda Whole Genome Sequencing Study: This research project is sponsored by Takeda Pharmaceuticals, one of the world’s largest pharmaceutical companies. In this project, researchers are using whole genome sequencing technology to increase our knowledge about genetic mutations related to certain diseases such as hemoglobinopathies or rare blood disorders. They are also trying to identify new treatment options based on these mutations that could help improve patient outcomes overall.

5. Verily Life Sciences Patient Health Monitoring Project: This project involves Verily Life Sciences working with healthcare providers, payers and employers on an initiative called “Project Baseline” which uses wearables and other devices such as Fitbits or Apple watches to monitor patients’ health data in real-time while they go about their daily lives outside of a clinical setting. Through this project, Verily aims to understand how different lifestyle behaviors can influence health outcomes; enhance patient engagement; reduce healthcare costs; and ultimately improve population health management globally

6. GlaxoSmithKline’s digital platform trial: GlaxoSmithKline developed an innovative digital platform to conduct a clinical trial of its new asthma drug, mepolizumab, in the United States. The trial involved recruiting participants through a web-based interface, using secure electronic data capture (EDC) tools to collect and store data in real time, and utilizing mobile devices for remote patient monitoring. This decentralized clinical trial was able to reduce the traditional costs associated with running a large-scale clinical trial because it eliminated many of the steps required for enrollment and data collection. Additionally, it enabled GSK to recruit more geographically diverse participants who would not have been able to take part in a conventional trial setting.

7. Merck's MyEHRConnected study: Merck conducted the MyEHRConnected study, which sought to evaluate the efficacy and safety of its diabetes medication Januvia (sitagliptin). This was an international phase III study that utilized electronic health records (EHRs) from more than 60 sites located throughout Europe, Asia Pacific, Latin America and Canada in order to identify eligible patients with type 2 diabetes. The EHRs enabled Merck to recruit participants quickly without requiring physical visits or extensive paperwork. Furthermore, researchers could securely access patient data stored within the EHR system during the duration of the study for analysis and evaluation purposes—a process that would have been impossible with paper-based records.

8. Sanofi's Telcare Diabetes Trial: Sanofi conducted a revolutionary telephone-based randomized control trial known as the Telcare Diabetes Trial (TDCAT), which aimed to assess the impact of telemedicine on diabetes care management among patients at risk for complications due to uncontrolled blood sugar levels. Patients were randomly divided into two groups—one group received standard care while another group received a combination of traditional care plus remote support provided by nurses through weekly phone calls over a period of six months. Results showed that those participants receiving telemedicine services had significantly better glycemic control than those who did not receive any telemedicine services at all—highlighting one powerful benefit of decentralizing clinical trials using technology such as telephone communication services.

9. Novartis’wearable device clinical trial: Novartis launched an ambitious clinical trial involving 20,000 individuals across nine countries in order to evaluate whether wearable devices such as smart watches can detect early signs of heart failure before medical symptoms appear. The decentralized nature of this study offered numerous advantages over traditional studies in terms of cost savings as well as recruitment speed; enabling Novartis to rapidly reach out potential participants worldwide instead of relying solely on localized recruitment methods used previously by other companies conducting similar trials with much smaller sample sizes due to limited resources or geographic restrictions

10. Eli Lilly & Company's eCOA Study: Eli Lilly & Company recently completed an innovative eCOA (electronic Clinical Outcomes Assessment) study that leveraged mobile applications and internet-connected devices in order to record patient outcomes over longer periods of time compared with traditional studies involving paper forms or periodic clinic visits alone. By using this decentralized approach, Lilly was able to gather more accurate data while reducing costs associated with running conventional trials; making it possible for them to enroll larger numbers of patients in shorter periods than ever before.

11. The IQVIA-sponsored study by the Alzheimer's Prevention Initiative (API). This study was designed to evaluate the effects of an investigational oral form of the drug solanezumab on the cognitive decline associated with early stage Alzheimer's disease. It was a decentralized trial conducted using remote monitoring, which allowed participants and clinical sites to interact online via web-based video visits, digital questionnaires and remote diagnostic testing. The trial collected data from over 800 participants at over 30 clinical sites in 12 countries.

12. A decentralized clinical trial launched by Durect Corporation to assess its investigational drug DUR-928 for the treatment of nonalcoholic steatohepatitis (NASH). The Durect NASH study was conducted across 16 countries and used innovative telemedicine technologies for patient monitoring and data collection. In addition to traditional site visits, remote video visits were performed with patients and caregivers to observe adverse events, review patient-reported outcomes, analyze lab results remotely and monitor compliance with the protocol.

13. The Institute for Qualitative Medicine’s (IQM) pilot study that evaluated an innovative approach to decentralizing clinical trials using mobile health technology (mHealth). The mHealth platform was used to connect participants remotely with healthcare professionals who monitored vital signs such as blood pressure, heart rate, respiratory rate, oxygen saturation level and body temperature using wireless medical devices connected directly to smartphones or computers. In addition, the platform included a chatbot that trained participants on how to use their medical device correctly or send real-time reminders when it was time for follow-up appointments or tests.

14. An analysis conducted by PPD Incorporated comparing decentralized vs centralised clinical trials for a Phase IIb study evaluating an investigational vaccine for malaria prevention in children aged 1–6 years old. They found that decentralizing the trial saved approximately 25% in total resources spent compared to a centralized approach and resulted in shorter recruitment times due to increased convenience for both investigators and participants alike compared with centralised approaches where people had to travel long distances for appointments or procedures.

15. A global Phase IIIa research program sponsored by GSK which evaluated an experimental shingles vaccine involving over 17000 elderly individuals across 11 countries in Europe and Latin America including Argentina, Brazil, Chile, Colombia, Germany Spain France Italy Netherlands Poland Portugal UK..The study incorporated various decentralized models such as virtual/remote clinic visits with self-administered questionnaires through smartphones/tablets; home delivery of intervention product; remote diagnostics; online physician/patient communication through video calls; collection of sample storage through kits sent remotely from local courier companies etc., thus enabling a truly distributed model of conducting clinical trials without relying solely on physical presence at site locations

Want to train your staff to run decentralized clinical trials? Enroll them in our in-depth clinical trial certification courses with hours of lectures focuses on remote monitoring alone.

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Los Angeles Unified School District sued over mandatory vaccine, digital tracking policy 3/23/21

(The Center Square) – California Educators for Medical Freedom, with assistance from the Health Freedom Defense Fund (HFDF), has sued the Los Angeles Unified School District over its mandatory vaccine policy and digital tracking system. Both violate federal law and basic human rights, the plaintiffs argue. The second-largest school district in the U.S. is mandating that its employees be vaccinated as a condition of employment. The lawsuit claims the mandate is not only unconstitutional, but it is unethical and violates the most fundamental human rights laws. The Los Angeles County Department of Public Health has reported 1,191,923 positive coronavirus-related cases, accounting for 11 percent of the population, since last March. Among them are 21,345 COVID-related deaths and 1,661 current hospitalizations. Of the county’s 9.9 million residents, those who have died from or with the coronavirus account for 0.2 percent of the population; those who are currently hospitalized, 0.01 percent. Los Angeles Unified School District sued over mandatory vaccine, digital tracking policy:

The COVID-19 vaccines were made possible through a federal Emergency Use Authorization initially issued under the direction of former President Donald Trump and renewed under President Joe Biden. No COVID-19 vaccines have been licensed or approved by FDA. Through emergency use authorization, medical products like vaccines are referred to as “investigational.” Prior to receiving the shot, recipients are required to be informed that the drug is experimental and be given “the option to accept or refuse administration of the product.” Unlike traditional vaccines that inject part of a virus into the body to force the body to create an antibody, the Pfizer and Moderna shots inject genetic technology to alter the body’s approach to creating an antibody. The shots are not vaccines according to the CDC’s definition of a vaccine, numerous doctors have pointed out, including Dr. Steven Hotze, in Houston, who has sued Gov. Greg Abbott over several emergency orders related to the coronavirus. The injections being pushed out by public officials and healthcare providers are new, genetic engineering technology, which have never been introduced to the public and involve injecting a genetic sequence, a messenger RNA (mRNA), into the body. The mRNA prompts the body to manufacture a spike protein believed to be on the surface of Sars-CoV-2 that is supposed to cause the body to create an antibody response. Los Angeles Unified School District sued over mandatory vaccine, digital tracking policy:

None of the pharmaceutical companies that have manufactured the drugs have provided any evidence of their short, medium, or long-term effects over any period of time, critics, including the HFDF, argue. It is also unknown how long the body’s response to creating antibodies will continue, where the spike proteins will migrate, how long they will continue to be produced, or which organs they would impact, the HFDF points out. “Since implementation of the Nuremberg Code, free nations have recognized that forced medical experimentation of any kind is both inhumane and unethical,” the HFDF states in a news release. The internationally recognized human right against medical experimentation was ratified by the 1964 Declaration of Helsinki and is protected by U.S. federal code. In 2005, the General Conference of UNESCO adopted the Universal Declaration on Bioethics and Human Rights to require free and informed consent for participation in medical research-oriented drug therapies. “There can be no doubt these treaties and regulations reaffirm the basic human right to bodily autonomy and the right to voluntary informed consent,” the plaintiffs argue. “By choosing to mandate experimental Covid-19 vaccines, LAUSD is forcing employees to choose between providing for their families and being the victim of human experimentation. Forced vaccination is not only unethical, it violates the tenets fundamental to a free society and must stop,” the HFDF argues. “There is no pandemic exception to the law or the Constitution.” Los Angeles Unified School District sued over mandatory vaccine, digital tracking policy:

Dallas Morning News Photo URL Their complaint states that the FDA can only authorize emergency use medicines through federal code, 21 U.S.C. § Section 360bbb-3, which requires informed consent and the right to refuse receiving the experimental drug. Also, emergency use authorization is not permanent. The current injections can only be administered legally for the duration of the emergency authorization. The FDA published several fact sheets related to COVID-19 vaccines including instructions to providers, Fact Sheet for Health Care Providers and Fact Sheet for Recipients and Caregivers, both of which require informed consent and the option to refuse administration of the drug. According to the complaint, LAUSD employees began receiving communication last month from Superintendent Austin Beutner and others instructing them to make appointments to get vaccinated. On March 4, employees received guidance from LAUSD, saying, “The Moderna vaccine is currently being administered by Los Angeles Unified nurses and other licensed healthcare professionals to Los Angeles Unified employees. You will schedule your appointment . You will provide proof of vaccination via the DailyPass for time reporting purposes.” The LAUSD also launched Daily Pass, an app “designed to coordinate health checks, COVID tests and vaccinations for a safe reopening of schools.” “Sort of like the golden ticket in ‘Willy Wonka,’ everyone with this pass can easily get into a school building,” Beutner said during his weekly update on Feb. 22. Los Angeles Unified School District sued over mandatory vaccine, digital tracking policy:

The Cochran Firm -Photo URL The technology, which was developed with support from Microsoft, generates a QR code for each student and staff member allowing them entry to a specific LAUSD location for one day only, as long as the individual receives a negative test result for COVID, shows no symptoms and has a temperature under 100 degrees. “Since last June, our teams have been collaborating closely with Los Angeles Unified to support running schools remotely,” Microsoft's corporate vice president of Windows product and education, Eran Meggido, told Fox Business. Once an individual arrives on campus, their QR code is scanned by a LAUSD site leader who also takes the individual’s temperature. The Daily Pass will be used to register and schedule appointments, track vaccines in stock, perform check-in and data capture at time of appointment, sort high-risk individuals, offer waitlists to low-risk individuals and dashboards to view data, among other features. Los Angeles Unified School District sued over mandatory vaccine, digital tracking policy:

ICTworks- photo URL LAUSD is the first school district to announce it is requiring every student and employee to have a Daily Pass in order to receive education in a taxpayer-funded public school system. All LAUSD employees and students 13 years and older, their family members, using computers and mobile devices, will be required to use it. Anonymized data will be shared with public health officials, research and health care collaborators – Stanford University, UCLA, The Johns Hopkins University, Anthem Blue Cross, and Healthnet and Cedars Sinai. In December 2020, Children’s Health Defense published “Vaccine Mandates: An Erosion of Civil Rights?” which surveys the history of vaccine mandates in the U.S. and provides information to help Americans understand their constitutional rights. Los Angeles Unified School District sued over mandatory vaccine, digital tracking policy: - Bethany Blankley For More California news VISIT # Los Angeles Unified School District #  mandatory vaccine # digital tracking Read the full article

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Coronavirus updates: Wuhan reports first day with zero new cases

Health workers screen a patient for coronavirus on March 18 at a drive-through testing site in Arlington, Virginia.

Drew Angerer/Getty Images

For the most up-to-date news and information about the coronavirus pandemic, visit the WHO website.

COVID-19, the disease caused by the novel coronavirus, has rapidly spread and reached the stage of international pandemic. Cities, states and countries have mandated quarantines. Health care systems are scrambling. Entire industries have shut down. Companies have switched to working from home and tried measures to help hourly workers. Tech giants have been hit by supply chain problems. Social media networks have wrestled with the spread of misinformation and conspiracy theories.

Get all the latest on the coronavirus that’s now been declared a pandemic.

The spread of COVID-19 has progressed at a blistering pace. If you’re wondering what a coronavirus is, what the symptoms are and how you can protect yourself, head over to CNET’s FAQ. We’ve created a timeline for the virus below, in reverse chronological order, and will update it with the latest developments each day.

Coronavirus timeline

March 19

FDA approves ‘compassionate use’ for several patients, Trump says

During a briefing Thursday, US President Donald Trump said his administration has “slashed red tape” to develop vaccines and therapies for coronavirus as fast as possible. The president also said the US Food and Drug Administration has approved “compassionate use” for several coronavirus patients, allowing them to try experimental drugs that haven’t yet been approved by the FDA. 

Also during the briefing, FDA Commissioner Stephen Hahn said the agency is looking at drugs already approved for other uses, including an anti-malaria drug called hydroxychloroquine, as possible treatments for coronavirus. However, he stressed that experts would be doing this in the setting of a clinical trial. 

March 18

Wuhan reports first day with zero new cases

The central Chinese city of Wuhan is reporting zero new COVID-19 cases for the first time since the outbreak began in December last year. According to CGTN, a Chinese media service, the Chinese mainland reported zero new domestically transmitted cases, marking a turning point in the battle against the virus at the outbreak’s epicenter. 

NYSE moves to digital trading

The New York Stock Exchange will move temporarily to fully electronic trading as of market opening on Monday, March 23. Facilities closing include the NYSE equities trading floor in New York, NYSE American Options trading floor in New York and NYSE Arca Options trading floor in San Francisco. NYSE called it a “precautionary” measure.

Deferring tax payments will keep $300B in the economy

The US Treasury and the IRS say deferring of tax payments from April 15 to July 15 “will result in about $300 billion of additional liquidity in the economy in the near term.” Individuals owing $1 million or less and corporations owing $10 million or less may take advantage, but they must still file their tax returns by April 15.

US Census collection delayed

Field collection of the 2020 US Census is being postponed, with in-person teams suspended until April 1. In late May, census takers are set to visit households that have not yet responded. “As we continue to monitor the evolving COVID-19 outbreak, we will adjust census taker and survey operations as necessary in order to follow the guidance of federal, state and local health authorities,” the Census Bureau said.

It’s possible to complete the Census online, however. The bureau encourages filling it out as soon as possible.

UK shuts schools starting Friday

All schools in the UK will be closed from Friday until further notice, UK Prime Minister Boris Johnson announced on Wednesday. Schools will be required to make provisions for the children of key workers, including doctors and nurses, and must also continue to care for the most vulnerable children. Children who receive free school meals will be given vouchers to ensure they still are able to claim a free daily lunch. No school exams will take place this year. Johnson has asked parents not to leave children with older grandparents or those in other vulnerable groups.

FCC bends rules on remote learning and health

The FCC will allow healthcare providers, schools and libraries to accept gifts like Wi-Fi hotspots, networking equipment and other equipment and services from internet providers for telehealth and remote learning efforts during the coronavirus pandemic, Chair Ajit Pai tweeted. The FCC’s Wireline Competition Bureau is waiving the gift rules for its Rural Health Care (RHC) and E-Rate programs until Aug. 30.

Trump invoking Defense Production Act

President Trump said he’s invoking the Defense Production Act, which allows him to expedite and expand production of critical equipment — such as ventilators, respirators and protective gear — from the US industry. “It can do a lot of good things if we need it and we will have it all completed, signing it in just awhile,” Trump said at a coronavirus task force briefing.

Americans asked to wait on elective medical procedures 

Also at the briefing, Vice President Mike Pence called on Americans to postpone all elective medical procedures. 

Naval hospital ships will be deployed 

Secretary of Defense Mark Esper said he has directed the Navy hospital ships Mercy and Comfort to deploy “to increase the nation’s medical capacity.” Each ship contains 1,000 beds, a pharmacy, operating rooms and a medical laboratory. It is unclear at this point exactly how the ships will be used once deployed.

US closes border with Canada to ‘non-essential’ traffic

The US will close its northern border with Canada to all “non-essential” traffic amid the pandemic, President Trump announced. “We will be, by mutual consent, temporarily closing our Northern Border with Canada to non-essential traffic,” the president tweeted. “Trade will not be affected.”

Australia announces global travel ban

Australian Prime Minister Scott Morrison has announced an indefinite ban on international travel across the entire globe for Australian citizens and residents. “Do not go overseas,” Morrison said in a press conference, adding the most cases the nation has seen have been from Australians returning from an international trip.

Australia has also banned non-essential indoor gatherings of 100 or more people, with the outdoor limit still set for 500. Morrison called for hoarders of household goods to stop, labelling them “un-Australian.”

Anzac Day services for April 25 will now only be held online.

March 17 

Coronavirus spreads to all 50 US states

With West Virginia reporting its first case of coronavirus, COVID-19 has now spread to all 50 states in the US.

Kansas closes schools through summer

Kansas Gov. Laura Kelly on Tuesday ordered all public schools serving kindergarten through high school students to be closed for the rest of the academic year.  Officials plan to continue educating students and have formed a panel produce lesson plans and other guidance for schools.

Stocks up on Trump economic plans

Stocks rose as US President Donald Trump promised he’s “going big” and preparing to ask for an $850 billion aid package to blunt the economic impact of the coronavirus. Treasury Secretary Steven Mnuchin said the Trump administration wants to get emergency funds in Americans’ pockets “immediately.”

“Americans need cash now,” Mnuchin said during a White House press briefing. “I mean now in the next two weeks.” The proposal to send checks requires congressional approval. The previous day saw one of the worst drops in the market’s history as the US and the world continued to react to the pandemic’s spread.

New York halts state debt collection

Gov. Andrew Cuomo announced New York won’t be collecting any state debts for at least the next 30 days. This includes “student debt, medical debt & other state-referred debt,” Cuomo tweeted.

Tax day payments postponed

The IRS has extended its tax payment due date by 90 days, said Treasury Secretary Steven Mnuchin. People are still encouraged to file on time by April 15, but you can delay payments if you owe money to the IRS, with interest and penalties being waived.

MGM resorts close across Vegas

Some of the biggest resorts and casinos in Las Vegas have closed, with MGM Resorts shutting down Bellagio, Aria, MGM Grand, Mandalay Bay, Delano, Mirage, New York New York, Luxor and Excalibur. The company won’t take reservations prior to May 1. 

“We will plan to reopen our resorts as soon as it is safe to do so,” Jim Murren, CEO of MGM Resorts, said. 

UK government warns against travel

British residents were advised against “all but essential international travel.” The government sent a travel advisory email adding that “any country or area may restrict travel without notice.”

March 16

Trump announces new guidelines for next 15 days

Trump announced a series of guidelines for all Americans to follow over the next 15 days:

Avoid gatherings of more than 10 people.

Avoid discretionary travel like shopping trips and social visits.

Avoid bars and restaurants and food courts — instead use drive-through, pickup and delivery options.

Do not visit aged care facilities.

If you work in health care, pharmaceutical or food supply, “you have a special responsibility to maintain your normal work schedule.”

If someone in your house has tested positive, the entire household should stay home.

Older people and those with underlying health conditions should stay home.

The guidelines also recommend states with evidence of community spread should close all bars, restaurants, food courts, gyms and indoor and outdoor venues. “It’s just so contagious,” Trump said during a White House briefing.

Trump said he was tested for the coronavirus “very late Friday night,” with the results coming back negative.

San Francisco Bay Area locks down

San Francisco Bay Area residents will be required to stay home except for essential needs due to the spread of the coronavirus, Mayor London Breed announced Monday at a joint press conference with leaders of the surrounding six counties. The measures go effect Tuesday to slow the spread of COVID-19, although “necessary government functions and essential stores” will still be open.

New Jersey ‘strongly discourages’ travel between 8 p.m. and 5 a.m.

A curfew is being recommended by New Jersey Gov. Phil Murphy for between 8 p.m. and 5 a.m., saying “This will remain in effect for the foreseeable future. We want everyone to be home, and not out.” As of 8 p.m. PT Monday, all gatherings of over 50 are banned, and all movie theaters, gyms, casinos and racetracks will be shut down. Essential businesses like supermarkets, grocery stores, medical offices, gas stations and pharmacies may remain open later than 8 p.m., Murphy said.

Microsoft’s Bing launches tracking map

Microsoft’s search tool Bing has launched its own web portal to track the spread of coronavirus globally. It also links to news articles.

G7 leaders pledge to do ‘whatever is necessary’ to fight pandemic

In a statement on Monday, world leaders said they’re committed to working together in order to protect people during the coronavirus pandemic. The Group of Seven — a intergovernmental organization of seven countries including the US — said it will pool “epidemiologic and other data to better understand and fight the virus,” as well as “forcefully address” the economic impact of the outbreak.

Qantas refunding all flights

One day after Australian Prime Minister Scott Morrison announced a mandatory 14-day quarantine on anyone flying into Australia — aside from those from Pacific islands — Qantas has said it will refund all flights that have been booked for travel up to May 31 in Qantas store credit.

Europe proposes ban on incoming travel

The president of the European Commission on Monday proposed a month-long ban on nonessential incoming foreign travel to the EU. Individual governments would have to agree to the restrictions, which would apply to travelers from outside the EU, but not to British citizens. 

“Here in Europe we are heavily affected by the virus and we know that everything that reduces social interaction also reduces the speed of the spread of the virus,” said President Ursula von der Leyen. “The less travel, the more we can contain the spread of the virus.”

NY, NJ and CT take join action

The governors of New York, New Jersey and Connecticut on Monday said they’re taking joint regional action to reduce the spread of COVID-19. Gyms, movie theaters and casinos in all three states will be temporarily closed starting Monday evening. Bars and restaurants will be restricted to take-out and delivery only. Also, in line with CDC recommendations, gathering are being restricted to no more than 50 people throughout the three states. 

March 15

CDC recommends eight-week hold on public events

The CDC recommended that US gatherings of 50 or more be canceled or postponed for the next two months. 

“CDC, in accordance with its guidance for large events and mass gatherings, recommends that for the next eight weeks, organizers (whether groups or individuals) cancel or postpone in-person events that consist of 50 people or more throughout the United States,” the CDC said in a statement. The recommendation does not apply to the day-to-day operation of schools, businesses or institutions of higher learning, the CDC said. 

Fed slashes rates to almost zero 

The Federal Reserve slashed interest rates a full percentage point to near-zero to prop up the economy amid the coronavirus outbreak. “Consistent with its statutory mandate, the Committee seeks to foster maximum employment and price stability,” the Federal Reserve said in a statement. The effects of the coronavirus will weigh on economic activity in the near term and pose risks to the economic outlook.

Italy reports sharp one-day increases 

Italian health officials reported 3,590 more cases Sunday, the country’s largest single-day increase so far, and 368 deaths (also a single-day record). Total cases in the country total more than 24,000, with deaths at more than 1,800. That’s the most outside China. 

California night clubs, wineries and bars ordered closed

California Gov. Gavin Newsom on Sunday ordered the closure of all “bars, nightclubs, wineries, brewpubs and the like” to combat the spread of coronavirus. Restaurants are exempt from the order because they’re considered an essential business, but they will be required to halve their occupancy to maintain appropriate social distancing.

New York City closes schools

New York City’s public school system will shut down to stem the spread of the coronavirus, New York Gov. Andrew Cuomo announced. The system, the largest in the country with more than 1 million students, previously shut down nine public schools because a student or school personnel had tested positive for the virus.

No public Easter celebrations, Vatican says 

The Vatican said its traditional Easter week celebrations would be held without worshippers this year. “Because of the current global public health emergency, all the liturgical celebrations of Holy Week will take place without the physical presence of the faithful,” the Prefecture of the Pontifical Household said in a statement.

Also on Sunday, Pope Francis left the Vatican to visit two important pilgrimage sites in Rome and to pray all who are either sick and caring for the sick, a Vatican statement said. “With his prayer, the Holy Father pleaded for an end to the pandemic that has struck Italy and the world. He also implored the healing of the many sick people, remembered the numerous victims of these past days and asked that their families and friends might find consolation and comfort.” 

Germany closes land borders 

As cases in Germany reached 5,000, the country announced that it will temporary close its borders with France, Switzerland, Austria Luxembourg and Denmark starting 8 a.m. local time on Monday. Goods will still move freely and commuters will be allowed to cross borders for work. Interior Minister Horst Seehofer said the government needed to “disrupt the chains of infection” to contain the spread of the disease and “to do that, we have to limit not only large events and social contact, but also the movement of people.”  

Former Schiff aide tests positive

Rep. Adam Schiff (D-California) said Sunday that a former aide on his staff has tested positive for coronavirus. Schiff said in a tweet that the former staffer likely contracted the virus after leaving his office 10 days ago and that no other staffers are exhibiting any flu-like symptoms.

In Rome on March 15, Pope Francis prays in S. Marcello al Corso church, where home to a crucifix that in 1552 was carried around Rome in a procession to stop the great plague.

Vatican Media/AFP via Getty Images

March 14

Spain, France impose restrictions

After imposing a lockdown Friday on the Catalonia region, the Spanish government on Saturday ordered all the country’s citizens not to leave their homes except to go to work, buy food, seek health care or help those in need of care, The New York Times reported. The Times also said France has ordered all “non-indisensible” businesses to close as of midnight. That includes bars, restaurants and movie theaters but excludes grocery stores, banks and gas stations. Meanwhile, the paper noted, Poland said that come Sunday, it would seal its borders to everyone except citizens, and Denmark said all foreigners without an essential reason for visiting would be refused entry. In a move earlier in the week, all of Italy had already been sealed off, and only banks, grocery stores and pharmacies remain open there.

Trump tests negative; US expands travel ban; House OKs relief package

US President Donald Trump tested negative for the coronavirus, his doctor said late Saturday, according to The Washington Post. During a Saturday morning press conference, Trump said he’d been tested for the coronavirus Friday night, with the results still to come. Several people Trump has had contact with at his Mar a Lago property have tested positive.

Also at that press conference, Vice President Mike Pence said the federal government is extending a ban on travel from Europe to the US, with the ban now including Britain and Ireland. That move is set to go into effect at midnight on Monday.

On Friday, the US House of Representatives passed a major relief package for people affected by the coronavirus. Among other things, the package ensures paid sick and emergency leave, enhances unemployment insurance, and increases federal funding for Medicaid and for food assistance programs.

New York Gov. Andrew Cuomo reported the first death in New York City. Cuomo said the victim was an 82-year-old woman with a preexisting respiratory disease. The New York Times later clarified that the woman died in Brooklyn. Later still, officials announced the second death in New York state, a 65-year-old man north of Manhattan with “significant health problems,” the paper noted.

Apple continues coronavirus efforts

Apple said it’s closing all its stores outside of Greater China until March 27 due to coronavirus worries. The company also said it will accept COVID-19 and coronavirus-related apps only from “recognized entities such as government organizations, health-focused NGOs, companies deeply credentialed in health issues, and medical or educational institutions.”

March 13

AMC has capped its movie theaters at 50% capacity, with no more than 250 seats to be filled per movie, so those inside can practice social distancing; the Everest climbing season has been shut down early; Washington, DC, is banning gatherings of 250 or more people; and Boston closes all schools for six weeks.

Trump to host talks with G7 leaders

US President Donald Trump spoke with French President Emmanuel Macron, discussing how the two nations could work together to stop the coronavirus pandemic, with Trump agreeing to “host a videoconference on the coronavirus with all of the G7 leaders early next week,” Judd Deere, special assistant to the president and White House deputy press secretary, announced late Friday. The G7 includes the US, France, the UK, Germany, Canada, Italy and Japan.

Trump declares national emergency

Trump declared a national emergency, saying the move will open access to $50 billion in federal funds for states, territories and localities in the fight against the coronavirus. The president said he’ll “most likely” be personally tested for the coronavirus soon.

Trump also said the UK might have to be included in the US’ European travel ban due to more cases being reported there overnight, and he announced that Google is helping build a website for coronavirus information. Later, the president tweeted that cruise line companies Carnival, Royal Caribbean, Norwegian and MSC have agreed to suspend outbound cruises for 30 days from midnight.

Trump Friday evening declared Sunday, March 15 as a “national day of prayer.”

US looks at Families First Coronavirus Response Act

House Speaker Nancy Pelosi said she reached agreement with the Trump administration to pass the Families First Coronavirus Response Act that she said will protect families. Trump said Friday evening he “fully supports” the legislation, which he said covers free coronavirus tests and paid sick leave.

San Francisco bans evictions, prohibits gatherings of 100 people

San Francisco Mayor London Breed announced a moratorium on evictions caused by “loss of income related to a business closure, loss of hours or wages, layoffs, or out-of-pocket medical costs caused by the coronavirus pandemic.”

“Protecting public health means keeping people secure in their homes,” Breed said. The mayor also prohibited all non-essential gatherings of 100 or more people effective immediately.

March 12

US states have begun banning large gatherings of people with some exceptions; France has closed all schools and universities until further notice; head coach of English soccer club Arsenal Mikel Arteta has been diagnosed with COVID-19, with the entire first squad now in self-isolation; all Smithsonian Museums across New York and Washington DC, as well as the National Zoo, will close March 14; and a second Utah Jazz player, Donovan Mitchell, has tested positive for the coronavirus, according to ESPN.

Sophie Trudeau tests positive for COVID-19

Sophie Trudaeu, former TV host and wife of Canadian prime minister Justin Trudeau, has tested positive for COVID-19. According to tweets by the prime minister on Wednesday, Sophie was experiencing mild flu-like symptoms upon return from the United Kingdom. As a precaution, the prime minister will go into self-isolation for 14 days. 

Disneyland is closing as California halts gatherings of 250 or more

California Gov. Gavin Newsom introduced new guidelines that say all private and public gatherings of 250 people or more should be canceled for the rest of March. Newsom said this didn’t apply to casinos, card rooms, theaters or Disneyland “because of the complexity of their unique circumstance,” and he added that he’d spoken with former Disney CEO Bob Iger on March 11 and decided the Disney theme parks in Anaheim could remain open. Nevertheless, later Thursday, Disney Parks decided to shut down those venues till the end of the month.

It’ll be closing the doors of the Disneyland and California Adventure theme parks as of March 14, though the Downtown Disney shopping and dining area will remain open. Disney’s three hotels at Disneyland — the Disneyland Hotel, Paradise Pier and the Grand Californian — will remain open until March 16 to allow for guests to make travel plans. Disney Parks said there have been no reported cases of COVID-19 at Disneyland.

Disney World and Disneyland Paris are closing

Following the announcement of Disneyland closing, the Disney company said Walt Disney World and Disneyland Paris would also be closing on Sunday, March 15, through the end of the month. This includes the Disneyland Paris and Walt Disney Studios parks in France, and the Magic Kingdom, Epcot, Animal Kingdom, Disney’s Hollywood Studios, Typhoon Lagoon and Blizzard Beach parks in Orlando, Florida.

The Disney Village and Disney Springs shopping and dining areas and the multiple hotels on each property will remain open, said ABC, which is owned by Disney. Disney Cruise Line will also suspend new departures as of March 14 for the remainder of the month.

New York stops gatherings of 500, including Broadway shows

New York Gov. Andrew Cuomo announced that all gatherings of 500 or more people should stop, with the rule going into effect Friday. The exception is Broadway theaters, which’ll be closed as of 5 p.m. ET tonight.

Ohio bans gatherings of 100-plus people

Ohio Gov. Mike DeWine announced a ban of 100 or more people in a single room or single space, including stadiums, arenas, conference rooms, meeting halls, cafeterias, auditoriums, parades, fairs and festivals but not including airports, bus and train stations, medical facilities, malls, grocery stores, restaurants, factories, offices and schools where there can be large groups but “it is unusual for them to be within an arm’s length of one another.” The Ohio ban also doesn’t include religious gatherings. Ohio has five confirmed cases of COVID-19.

US Capitol reportedly stops all public tours

The US Capitol will reportedly halt all public tours through at least the end of March. The decision was made jointly by congressional leaders, Capitol security officials and medical staff, Politico reported. By the end of the week, the Capitol complex is expected to be restricted to official business only. 

Princess Cruises halts operations

The Carnival-owned cruise line said Thursday that all 18 of its cruise ships will cease operations for 60 days, starting Thursday. “Those currently onboard a cruise that will end in the next five days will continue to sail as expected through the end of the itinerary so that onward travel arrangements are not disrupted. Current voyages that are underway and extend beyond March 17 will be ended at the most convenient location for guests, factoring in operational requirement,” the company said in a statement.

March 11

Coronavirus has been declared a pandemic, E3 has been canceled, the US House and Senate may announce a halt to tours of the US Capitol, production on CW series Riverdale has been shut down, and the GLAAD Awards have been cancelled.  

WHO declares outbreak a pandemic

The World Health Organization has officially declared the coronavirus outbreak a pandemic. Tedros Adhanom Ghebreyesus, WHO director-general, made the announcement Wednesday, saying that “pandemic is not a word to use lightly or carelessly.”

Trump suspends travel from Europe to US

No travelers will be allowed to enter the US from most of Europe for 30 days, the president said during an evening briefing. “These restrictions will be adjusted subject to conditions on the ground,” Trump said in a rare televised address from the Oval Office. “There will be exemptions for Americans who have gone through appropriate screenings.”

Tom Hanks, wife Rita Wilson test positive

In what is perhaps the highest-profile coronavirus case yet, the actor shared on Instagram that he and his wife tested positive for the illness. They will self-isolate until instructed otherwise. 

Italy to close most stores

Italy is closing all stores apart from food shops and chemists, according to a report.

NBA suspends rest of season

The rest of the NBA’s 2020 season is suspended indefinitely, following follows Utah Jazz player Rudy Gobert testing positive for the coronavirus. 

Earlier in the day, the Golden State Warriors barred fans from home basketball games, announcing in an official statement that its March 12 game vs. the Nets at San Francisco’s Chase Center will be played without fans in attendance. Fans with tickets to this game will receive a refund in the amount paid. All events though March 21 will also be canceled or postponed. 

NCAA limits number of fans at games

The NCAA announced that only essential staff, players, coaches, and limited family members will be able to attend the 2020 men’s and women’s NCAA championships. “While I understand how disappointing this is for all fans of our sports, my decision is based on the current understanding of how COVID-19 is progressing in the United States,” NCAA President Mark Emmert said in a statement. This includes holding March Madness without any fans in attendance.

Annual NAB Show canceled 

The annual Las Vegas show is off. “NAB is evaluating a number of alternatives to the April show,” organizers said in a statement. 

E3 2020 canceled

Rumors have been swirling for weeks that the world’s biggest video game trade show would be canceled. On Wednesday, the Entertainment Software Association, the group behind E3, called the event off. The ESA said it’ll look into conducting an online showcase in place of E3 in June. 

Trump: We are putting together a plan

Trump says the government is “putting into policy a plan to prevent, detect, treat and create a vaccine against CoronaVirus to save lives in America and the world.” Trump said he is prepared to use the government’s “full power” to deal with the spread of COVID-19. Trump will be addressing the nation at 6:00 p.m. PT from the Oval Office.

CES Asia 2020 postponed

CES Asia, the sibling of the world’s biggest tech trade show, CES, was scheduled to take place June 10-12 in Shanghai but has been postponed by the organizing committee, the Consumer Technology Association. No new date was announced.

“Our decision reflects the concerns of our stakeholders including exhibitors, buyers, media and speakers. Given the evolving global concerns about and impact of the coronavirus (COVID-19), we feel this is the best decision for everyone involved, ” the Consumer Technology Association said in a statement.  

Making tax day less taxing

Trump suggested on Monday that his administration might give wage earners a “very substantial relief” in the form of a payroll tax cut. Trump might also be looking to extend the April 15 deadline for US residents to file their federal taxes, The Wall Street Journal reported. A filing extension would effectively serve as a “bridge loan” for individuals and businesses affected by the virus since they wouldn’t face fines or interest penalties.

US cases hit 1,000

The US has reported over 1,000 cases of COVID-19. The increasing number of positive cases comes against a backdrop of increased scrutiny on the US response, after reports showed the federal government “missed chances” to contain the outbreak early. 

Britain’s health minister infected

Nadine Dorries, the British health minister, has confirmed she tested positive for the coronavirus. According to the BBC, Dorries self-isolated at home and had started tracing people she had contact with. The same day she began showing symptoms, she had attended an event at which British Prime Minister Boris Johnson also was present. 

Dorries took to Twitter late on Tuesday to thank her followers for “many good wishes.”

Thanks for so many good wishes. It’s been pretty rubbish but I hope I’m over the worst of it now. More worried about my 84yo mum who is staying with me and began with the cough today. She is being tested tomorrow. Keep safe and keep washing those hands, everyone.

— Nadine Dorries

(@NadineDorries) March 10, 2020

Australia bans travel to Italy, announces AU$2.4B package

Australian Prime Minister Scott Morrison held a press conference Wednesday morning local time, announcing that Australians will be banned from traveling to Italy as of 6 p.m. AEDT on March 11. Morrison also provided details on how a AU$2.4 billion ($1.6 billion) response package will be spent, including on establishing 100 pop-up fever clinics across the nation; providing free health sessions with doctors over FaceTime, Skype and WhatsApp video calls; and helping support aged care facilities. The government is still finalizing some of the measures, with Morrison saying the package is about “keeping Australians in jobs, and keeping business in business.”

AU$30 million will be spent on research into vaccines and treatments. The Australian government said there’s “no point” in being tested for COVID-19 right now even if you do feel sick unless you’ve traveled or been in contact with someone who is a confirmed case.

Meanwhile, another three cases were diagnosed in Melbourne on Wednesday — all three patients had recently traveled from the US to Australia.

March 10

Massachusetts declared a state of emergency, with 51 new cases reported and a total of 92 in the state. And in Nevada, buffets across Las Vegas are shutting down starting Sunday, at hotels including the Aria, Bellagio, MGM Grand, Mandalay Bay, Mirage, Luxor and Excalibur.

Zuckerberg works to increase testing in the Bay Area

The Chan Zuckerberg Initiative, owned by Facebook CEO Mark Zuckerberg and his wife, Priscilla Chan, are working with Stanford University to “quadruple UCSF’s COVID-19 testing and diagnostics capacities by funding the acquisition of two state-of-the-art FDA-approved clinical diagnostic machines.”

EU pledges 25 billion euros for coronavirus response

The European Union is setting up a 25 billion euro ($28 billion) investment fund to help address the financial crisis caused by the spread of COVID-19, Reuters said Tuesday. The European Parliament will be asked to finance the fund with 7.5 billion euros this week, European Commission President Ursula von der Leyen announced at a news conference. 

Trump hasn’t been tested for coronavirus

Trump confirmed he hasn’t been tested for COVID-19 because he’s feeling “extremely good” and has no symptoms. During a press conference Tuesday afternoon, Vice President Mike Pence said he and Trump will continue shaking hands with people.

New York sets up containment zone

The state of New York has created a “containment zone” in the city of New Rochelle just north of Manhattan, Gov. Andrew Cuomo said. The zone falls within “a 1 mile radius around the site of the most cases in New Rochelle,” Cuomo said on Twitter, adding that the city has the “biggest cluster of coronavirus cases in the state.” In the zone, large gathering places, including schools and places of worship, will be closed from March 12 till March 25. The National Guard will deliver food to those living in the zone, and a temporary testing facility has been set up. The move comes as New York announced another 31 cases in the state, for a total of 173.

Coachella and Stagecoach music festivals canceled

Coachella said the festival, originally scheduled for April 10-19, has been rescheduled for two weekends in October — Oct. 9-11 and 16-18. The corresponding Stagecoach festival will take place on Oct. 23, 24 and 25. Festival organizers say refunds will be given for those who can’t attend on the new dates.

Now playing: Watch this: Coronavirus and COVID-19: Everything you need to know

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March 9

Selling overwhelmed the US stock market, triggering an automatic halt that paused trading for 15 minutes, amid fears over the virus’ effect on the global economy. Sliding oil prices and a fall in Treasury yields contributed to the selling. Stocks rebounded when trading resumed, but then resumed sliding. The major indexes were off by more than 7% for the day. As measured by the S&P 500, stocks are down more than 15% since the beginning of the year, shortly after the new coronavirus was identified.

In Silicon Valley, companies urged employees to work from home to prevent the spread of the coronavirus. Santa Clara County, where many US tech giants are headquartered, and the San Francisco Bay Area more broadly, are the epicenter of the outbreak in California, the most populous state. Tech companies have said they’ll continue paying hourly staff during the outbreak. 

Meanwhile, sporting events like the lighting of the Olympic torch in Greece have reportedly been closed to the public, while the Serie A soccer tournament in Italy has been suspended.

Trump and Pence announce guidelines, more tests, financial help

President Trump said he will be announcing “very substantial relief” on a payroll tax cut “that’s a huge number,” as well as giving help to hourly wage earners and small businesses. During a White House press conference March 9, Trump said he’s been working with the airline, cruise ship and hotel industries because “we want people to travel to certain locations and not to other locations.”

Also speaking during the conference, Pence said all travel from China into the US has been suspended, while there are travel advisories for portions of South Korea and Italy, with all passengers coming from those countries to be screened on arrival in the US. Pence said commercial labs have brought a test forward and are making it available. Also, all state labs have a test available.

Pence said the Grand Princess cruise ship has docked in Oakland, California, with the 21 infected people in isolation. His team was hoping to disembark California residents to Travis Air Force Base that day, and made arrangements with Canada and the UK to take their passengers back. Those passengers were to be transported directly to the tarmac and flown home on chartered planes.

Trump didn’t respond to questions about whether he’s been tested. Pence hasn’t been tested, and said he will find out if Trump has. The guidance was to be released that evening on coronavirus.gov. The White House has also given additional guidelines to nursing homes around the country, with the virus now present in 35 states and the District of Columbia.

Italy shuts down entire country

Italy’s population of 60 million is now under restrictions, with Prime Minister Giuseppe Conte banning public gatherings and travel except for work and emergencies.

Qantas slashes international flights

Australian airline Qantas announced a series of changes to its flights due to the coronavirus, including grounding eight of its largest aircraft, the A380, until September. It’s also rerouting its Sydney-Singapore-London flights to go through Perth instead of Asia and delaying the launch of its new Brisbane-Chicago route. Its budget airline, Jetstar, has suspended flights to Bangkok (it suspended flights to Seoul last week) and reduced flights to Vietnam and Japan by almost half. 

Seattle confirms three more deaths

King County, home to Seattle, confirmed 33 new cases of coronavirus and three more deaths, bringing total deaths in the county to 20 and in the state of Washington to 22. 

Justice Department warns price gougers

The US Department of Justice warned that anyone found to be fixing prices or rigging bids of personal health protection equipment like gloves and face masks could face criminal prosecution.

FTC warns seven companies on cure and prevention claims

The US Federal Trade Commission and Food and Drug Administration sent warning letters to seven companies for advertising products that they falsely claim can cure or prevent coronavirus, including Silver Lozenges, herbal products, colloidal silver products, essential oils and frankincense.

NASA worker reportedly infected 

The NASA Ames Research Center in Silicon Valley in California is reportedly asking employees to work from home until further notice after one tested positive for COVID-19. The facility works on advanced computing, aerosciences and astrobiology. NASA didn’t immediately respond to a request for comment.

March 8 

In the US, coronavirus cases hit 500, with the worldwide case numbers topping 100,000. A full breakdown can be found using the Johns Hopkins case tracking tool. 

Sen. Ted Cruz in isolation US Sen. Ted Cruz released a statement Sunday detailing his interaction with a person who tested positive for COVID-19. Given the esposure, Cruz said he has decided to remain at his home in Texas for 14 days. The interaction occurred at the Conservative Political Action Conference approximately 10 days earlier. According to his statement, Cruz feels “fine and healthy.”

US State Department: ‘Avoid cruise ships’ The US State Department is advising travelers to forgo cruise ship travel, particularly those with underlying health conditions. In an update to its travel site March 8, the department said the “CDC notes increased risk of infection of COVID-19 in a cruise ship environment.”

The warning came as the Grand Princess cruise ship, which departed from San Francisco on a trip to Hawaii, was scheduled to dock in Oakland, California, on Monday. At least 21 passengers were confirmed as COVID-19 positive, including 19 members of the staff. The ship itself contained approximately 3,500 people and was to undergo a 14-day quarantine when it docked March 9. Passengers wouldn’t be required to stay on the vessel but would be moved to military bases around the country, according to CBS News.

Italy lockdown  The Italian government signed a decree ordering millions of people into lockdown across the northern part of the country. The order put the northern region of Lombardy, as well as 14 other regions, under travel restrictions, CNN reported. The lockdown quarantined tens of millions of citizens. Italy’s outbreak is the worst outside Asia and the worst in Europe, with over 7,000 cases and 300 deaths.

Public health checks have kicked in worldwide. Here, health workers take a man’s temperature before a soccer game in Italy in early March.

Gabriele Maricchiolo/NurPhoto via Getty Images

March 7: In the US, New York Gov. Cuomo declared a state of emergency and announced that the number of cases in the state had risen to 76. Elsewhere, Washington DC Mayor Muriel Bowser reported the US capital’s first infection, and Florida and Georgia both reported new coronavirus cases, a day after the Florida Department of Health announced the first deaths on the East Coast.

Also near DC, the American Conservative Union said an attendee at last week’s CPAC event had tested positive for the coronavirus, CNN reported. Trump and Pence were among those at the conference. The White House told CNN that “at this time there is no indication that either President Trump or Vice President Pence met with or were in close proximity to the attendee.” That person was receiving medical care in New Jersey. And Amtrak said its Acela nonstop train service between New York and Washington would be suspended from March 10 to May 26.

In the western US, Arizona, California and Oregon reported new cases, and an employee at a downtown Seattle Starbucks was diagnosed with COVID-19. The employee was quarantined at home, Starbucks told USA Today. “We quickly activated our protocols, immediately closing the store and initiating a deep clean overnight, following all recommended guidelines from the City of Seattle and King County public health authorities,” the company told the news service in a statement. It’s the first US coronavirus case reported by Starbucks, according to USA Today. Earlier in the week, Redmond, Washington-based Microsoft said two of its employees had been diagnosed with COVID-19.

The head of Italy’s co-governing Democratic Party, Nicola Zingaretti, said in a tweet that he’d been diagnosed with COVID-19, adding that he’s fine but has to remain at home. He said on Facebook that his family was following protocols and that local health officials were contacting people he’d been in contact with, CNN reported. Also in Italy, a US Navy sailor in Naples tested positive for coronavirus, the first recorded COVID-19 case for an American service member in Europe, the Navy Times reported. 

In Iran, a member of parliament, 55-year-old Fatemeh Rahbar, died from the coronavirus, Bloomberg reported. Rahbar was the second lawmaker in Iran killed by the coronavirus and one of several politicians and government officials who’d succumbed during the outbreak, The Times of Israel reported.

On the social media front, Facebook said it’s temporarily banning face mask ads to help curb the exploitation of fears around the coronavirus.

March 6: Coronavirus cases reached the 100,000 milestone globally, while Trump signed an emergency funding package, and the South by Southwest festival got canceled. The US also saw the first coronavirus deaths on the East Coast, with the Florida Department of Health announcing that two people had died from COVID-19.

Global cases hit a milestone Confirmed global cases of COVID-19 have now topped 100,000, according to a tracker developed at Johns Hopkins University. The tracker pulls data from the Centers for Disease Control and Prevention, the World Health Organization and other local and international health authorities.

Trump signs $4 billion emergency funding package Trump signed an emergency funding package, later tweeting that he spoke to California Gov. Gavin Newsom “about the cruise ship quarantined off the California coast.” Trump said test kits had been delivered for the cruise ship.

South by Southwest gets canceled Austin, Texas-based SXSW joined a growing list of events to pull the plug amid coronavirus concerns.  The event drew 417,4000 attendees in 2019. “Based on the recommendation of our public health official and director of public health and after consultation with our city manager, I’ve gone ahead and declared a local disaster. And along with that issued an order that cancels SXSW this year,” Austin Mayor Steve Adler said in a press conference, later calling the cancelation “unfortunate.” The cancellation followed multiple dropouts from companies and artists slated to appear at SXSW.

Deaths on the East Coast The East Coast of the US saw its first coronavirus deaths, with the Florida Department of Health announcing that two people had died from COVID-19. Both victims had traveled internationally, the department said.

Pennsylvania, Indiana, Minnesota, Kentucky, Hawaii confirm first cases Pennsylvania Gov. Tom Wolf confirmed that two people in the state had presumptive positive test results for the coronavirus. One of them, an adult from Wayne County who recently traveled to a country with an outbreak, was at home in isolation. The other, an adult from Delaware County who recently traveled to an area in the US where the coronavirus is spreading, was also at home in isolation.

Indiana health officials confirmed the first presumptive positive case of coronavirus. The adult patient, a Marion County resident, had recently returned from a conference in Boston. Officials said he’s now in isolation and in stable condition, according to officials. An investigation was underway. Indiana Gov. Eric Holcomb declared a public emergency to ensure additional funding.

Minnesota also confirmed its first case: an “older adult” in Ramsey County who traveled on a cruise ship with a known coronavirus case. The patient developed symptoms Feb. 25 and sought health care March 5, and was in quarantine at home while recovering.

Kentucky Gov. Andy Beshear confirmed the first case in Lexington and declared a state of emergency. There have been 10 tests, with nine coming back negative, he said in a press conference. Beshear gave no details about the sick person, except that he or she was in a medical facility. Kentucky repurposed the poison control hotline for COVID-19 calls  (800-222-1222).

Hawaii also confirmed its first case. The patient was likely exposed while aboard the Grand Princess cruise ship, with the Hawaii Department of Health saying it doesn’t think the patient came into close contact with anyone who was ill. There’s so far no evidence of community spread in Hawaii.

Kansas was investigating two potential cases. The Kansas Department of Health and Environment said 11 people previously been tested for COVID-19 but received negative results.

Passengers stranded on Grand Princess cruise More than 2,000 passengers remain stranded onboard a cruise ship off the coast of Northern California, CNET sister site CBS San Francisco reported. Pence said 46 people were swabbed, with 21 testing positive for the coronavirus — 19 crew members and two passengers. The ship was banned from docking in San Francisco but would be brought into a “noncommercial port” where all passengers and crew would be tested for the coronavirus, Pence said at a press conference.

The ship’s previous voyage from San Francisco to Mexico Feb. 11-21 so far resulted in one death and five diagnoses. Former passenger Margie Hartle told CBS that passengers weren’t tested before getting off the ship and that many were coughing during the bus ride back to Sacramento. “We were ground zero and you have 2,500 people walking out right now in Sacramento, up in the foothills, whatever, that might be carriers,” she said. 

March 5: Tennessee Gov. Bill Lee announced the first case of COVID-19 in Williamson County. A 44-year-old man tested positive on Wednesday and was quarantined at home. He had returned from Boston on a nonstop flight before falling ill, according to a report.

Maryland Gov. Larry Hogan said three people in the state have tested positive for the coronavirus. All three cases were in Montgomery County, and the patients were in quarantine at their homes. All three people, a couple in their 70s and an unrelated woman in her 50s, contracted the virus during overseas travel. Hogan declared a state of emergency to ramp up the state’s response. 

Google, Microsoft, Amazon tell some employees to work from home Some companies with offices in Seattle were telling employees to work from home when possible. A Google spokesperson confirmed the move after talking with local health officials. Microsoft published a post Wednesday saying that all Puget Sound and San Francisco Bay Area employees who can work from home should do so through March 25. New York Gov. Cuomo said the state is increasing its coronavirus testing capacity after approval to partner with more labs. Starbucks won’t let you fill your own cup anymore due to virus-spreading concerns, but it will continue to honor the 10-cent discount for those who do bring in their own cups.

San Francisco confirms two cases of unknown origin Mayor London Breed of San Francisco has confirmed two “community-spread” cases of COVID-19 in the city, meaning the patients weren’t known to have traveled or had contact with an infected person. During a press conference, Breed said a man in his 90s with an underlying health condition was in serious condition, and a woman in her 40s was in fair condition. The patients were unrelated and were being cared for in isolation at separate hospitals in the city.

Pelosi signs $8.5 billion emergency response package House Speaker Nancy Pelosi signed a bipartisan US emergency response package, which covers issues across employment insurance, food, telehealth, small businesses and schooling. It’ll help states and local governments with the costs they incur, and also help fund vaccine research. It was headed to President Trump’s desk for final signature.

IBM’s supercomputer is on the case IBM’s Summit supercomputer, one of the most powerful in the world, was joining the fight against COVID-19. Simulations can examine the virus faster than growing the microorganism in labs, IBM said. Jeremy Smith, governor’s chair at the University of Tennessee and director of the UT/ORNL Center for Molecular Biophysics, said the team was “very hopeful” the findings would help inform studies to find a treatment.

“Using Summit, researchers were able to simulate 8,000 compounds in a matter of days to model which could impact that infection process by binding to the virus’s spike, and have identified 77 small-molecule compounds, such as medications and natural compounds, that have shown the potential to impair COVID-19’s ability to dock with and infect host cells,” IBM said in a blog post, adding that this would’ve taken months on a normal computer.

March 4: One death in California was attributed to COVID-19, while New York City began cracking down on price gouging and Australia reported its second fatality.

Contagion movie rose on iTunes Steven Soderbergh’s decade-old story of how humans might respond to a deadly airborne virus hit the top 10 rentals.

Apple out of SXSW Apple canceled appearances at SXSW 2020, joining other huge tech brands like Facebook, TikTok, Amazon and Twitter in skipping this year’s festival because of coronavirus concerns. 

First fatality in California, state of emergency declared On Wednesday, Placer County Public Health in Northern California announced the first death in the state. The victim was an elderly adult with underlying health conditions, who tested positive on Tuesday after likely contracting the disease during a Princess Cruise from Feb. 11-21 between San Francisco and Mexico. The patient was put in isolation at Kaiser Permanente Roseville.

“The state is working with federal officials to follow up on contact tracing of individuals that may have been exposed,” California Gov. Newsom said in a statement. “This case demonstrates the need for continued local, state and federal partnership to identify and slow the spread of this virus.” During a press conference in Sacramento, Newsom then declared a state of emergency for California.

Washington also reported its 10th coronavirus death, while the virus was spreading further in New York. President Trump tweeted late Wednesday that Congress had voted to provide $8 billion in funding to help the COVID-19 response.

Pence says 1.5 million more test kits coming During a coronavirus conference, Vice President Pence said 1.5 million test kits were going out that day to hospitals. In addition, every state health lab and university lab could now conduct a coronavirus test. The goal was to get to a place where all doctors and clinics have access to tests, which he said would be possible “within a number of weeks.”

Second Australian fatality reported in Sydney A second COVID-19 death was confirmed in Australia. A 95-year-old resident of the Dorothy Henderson Lodge at Macquarie Park, an aged care facility just north of Sydney, was diagnosed with the coronavirus after dying. The first Australian coronavirus fatality occurred March 1 in Western Australia after a 78-year-old man returned from the Diamond Princess cruise ship.

The number of cases had risen to 22 in New South Wales, the state’s department of health said. The new cases included an female resident in her 70s at the same Macquarie Park facility; a female doctor from Liverpool Hospital; a female in her 30s from the Northern Beaches; a man in his 50s from Cronulla; and a woman in her 60s believed to have returned from the Philippines on March 3.

New York City to fine stores that jack up prices on supplies New York City tweeted it would begin issuing fines “to any store found price gouging supplies.” (Residents can call 311 to report price gouging.) Sen. Ed Markey on Wednesday sent a warning letter to Amazon CEO Jeff Bezos, asking him not to allow price gouging on the online retailer, while Washington Attorney General Bob Ferguson also warned stores against jacking up prices, saying “we are taking formal investigative actions.”

TED Vancouver conference reportedly delayed TED2020 Uncharted, a conference slated to take place April 20-24 in Vancouver, has reportedly been delayed. TED was considering postponing until July or doing “an expanded and ambitious digital experience,” a spokesperson told CNET in an email.

NASA and the US Air Force to reportedly test working from home Due to fears about the spread of the coronavirus, NASA and the US Air Force were set to test teleworking, according to a Politico report that cited a NASA spokesperson and an Air Force memo. The US Air Force said it’s required to test its telework capacity once a year, which it typically does during snow days. NASA said it’s “taking various actions” to be prepared for the spread of the coronavirus, including making Friday an agencywide work-from-home day. 

March 3: Two deaths in the Seattle area in the week beginning Feb. 24 were attributed to COVID-19, state health officials revealed, according to The New York Times. That brought the death toll in Washington state to nine. Seven new cases were announced in the state, bringing the total number of infections to 21. 

More SXSW cancellations After Facebook and Twitter pulled out of the SXSW festival in Texas on March 2, another social media platform followed suit: the short form video giant, TikTok.

In an emailed statement, the company said: “TikTok has decided not to participate in SXSW this year. While we think the risk is relatively low, we are erring on the side of caution as we prioritize safety for our team, creators, partners, artists, and brands. We are looking at a variety of alternative ways to bring parts of the previously scheduled experience to audiences in creative new forms.”

Tokyo 2020 in doubt Japan Olympic minister Seiko Hashimoto suggested the 2020 Tokyo Olympics could be postponed. 

“The IOC has the right to cancel the games only if they are not held during 2020,” Hashimoto reportedly told parliament. “This can be interpreted to mean the games can be postponed as long as they are held during the calendar year.”  

The International Olympic Committee has doubled down on efforts to ensure the games go ahead as planned. The opening ceremony is scheduled for July 24. The Paralympics are scheduled to run from Aug. 25. 

Google cancels I/O The biggest event on search giant Google’s calendar each year is I/O, a developers conference held in the San Francisco Bay Area. The I/O 2020 conference was scheduled to begin May 12, but Google has decided not to go ahead with the conference this year. Attendees will get a full refund, the company said in an email. 

“Due to concerns around the coronavirus (COVID-19), and in accordance with health guidance from the CDC, WHO, and other health authorities, we have decided to cancel the physical Google I/O event at Shoreline Amphitheater,” Google said in a statement. 

March 2: Confirmation of another four deaths in the US, all in Washington state.

German automaker BMW placed 150 employees under at-home quarantine, according to a report by Automotive News Europe. Germany at that point had reported around 160 cases of the disease.

SXSW sees two big names drop out Twitter announced it’s pulling out of SXSW, citing coronavirus concerns. A blog post from Twitter noted that the company is adjusting its travel policy. “On February 29, we informed our people and started notifying partners that we are suspending all non-critical business travel and events,” the blog post said.

Twitter’s attendance would have included a keynote address from CEO Jack Dorsey, as well as a larger presence from the company. In past years, Twitter has hosted speakers and events at its “Twitter House.”

Facebook announced it’s pulling out of SXSW due to fears over the COVID-19 outbreak.

Google Cloud, a platform that runs a suite of services on the search giant’s cloud, made its biggest event of the year, Google Cloud Next, digital-only. Scheduled for April in San Francisco, the event would now take place digitally, with “streamed keynotes, breakout sessions, interactive learning and digital “ask an expert” sessions with Google teams,” according to a blog post.

Coronavirus virus gets an official name: SARS-CoV-2 A paper, published in the journal Nature Microbiology by the Coronaviridae Study Group, officially designated the coronavirus that causes the disease “SARS-CoV-2.” In a slightly confusing move, the authors suggest it should be considered distinct from the virus that caused the SARS outbreak in 2002 and 2003 — but the virus is closely related to the coronavirus responsible for that outbreak.

The latest data shows that over half of all patients have recovered, with a total of 45,605 COVID-19 cases resolved. It’s unclear whether recovered individuals can be infected a second time.

March 1: A second US death was confirmed in Washington state, in the same facility as the first fatality. New York state confirms its first positive case.

In France, the Louvre, the world’s largest art museum, closed, as a secondary outbreak in Italy continued to spread through the northern region. Around 9.6 million people visited the museum in 2019. 

Feb. 29: The first fatality in the US from the coronavirus was confirmed by the Washington State Department of Health. The man was in his 50s with an underlying health condition, state health officials said. 

Washington Gov. Jay Inslee said Saturday that the state was working to keep its citizens safe, and he declared a state of emergency.

US Surgeon General Jerome Adams tweeted advice for the public to stop buying face masks, suggesting they’re not effective at preventing transmission. This echoed advice from the CDC, which “does not recommend” healthy people wear a face mask to protect themselves from any respiratory disease.

Feb. 28: The Game Developers Conference, a huge gathering of video game developers that takes place in San Francisco every year, was postponed. The event was scheduled to take place March 16-20 but big-name developers like Epic, Facebook/Oculus, Blizzard and Microsoft more decided to pull out.

“After close consultation with our partners in the game development industry and community around the world, we’ve made the difficult decision to postpone the Game Developers Conference this March,” the organizers said in a statement. “Having spent the past year preparing for the show with our advisory boards, speakers, exhibitors, and event partners, we’re genuinely upset and disappointed not to be able to host you at this time.”

The GDC didn’t provide a new date for the event, saying only that “we fully intend to host a GDC event later in the summer.” 

Feb. 27: Coronavirus concerns prompted cancellation of Facebook’s F8 developers conference, the biggest event for the social media giant. The event was scheduled for May 5-6.

“This was a tough call to make — F8 is an incredibly important event for Facebook and it’s one of our favorite ways to celebrate all of you from around the world — but we need to prioritize the health and safety of our developer partners, employees and everyone who helps put F8 on,” Konstantinos Papamiltiadis, Facebook’s director of developer platforms and programs, said in a statement.

Instead of F8, Facebook said it’s planning to bring developers together through locally hosted events, videos and livestreamed content.

Feb. 26: In a press conference, President Trump said the risk to Americans remains low. “The No. 1 priority from our standpoint is the health and safety of the American people,” he said. He noted that of the original 15 US cases, one remained in hospital and was “pretty sick,” with 14 others either fully recovered or in recovery. He also announced that Vice President Pence would coordinate the response to the virus.

The CDC confirmed local transmission of the virus had occurred in the US. This means the virus was able to spread from person-to-person in the US, rather than being imported by a traveler.

Feb. 25: A top Olympics official suggested the 2020 Tokyo Olympic games, scheduled to begin July 24, could be canceled, with a decision to be made by the end of May. 

Feb. 23: A number of high-profile events were canceled in Italy, including Serie A football matches and one of the world’s biggest fashion shows in Milan. The Venice Carnival, a world-famous masquerade, was also cut short. Tens of thousands of Italians were put into lockdown after a third death was recorded in the country.

Feb. 21: Italy reported the first person-to-person transmission of the virus and the total number of COVID-19 infections had risen to six. The cases were clustered in Italy’s Lombardy region, in the north. A day later, Feb. 22, Italy reported its first two deaths.

Feb. 20: South Korea reported its first death from the coronavirus.

Feb. 19: Iran’s first confirmed cases of COVID-19 were reported and, on the same day, its first two deaths.

One of the biggest video game conferences, PAX East, which takes place in Boston, saw a few cancellations. Sony, which manufactures the PlayStation and was scheduled to show off the highly anticipated title The Last of Us Part II, decided not to attend because of coronavirus concerns.

In a breakthrough, researchers working with the coronavirus created the first 3D map of a special protein that allows the coronavirus to get into human cells. Using state-of-the-art microscopy, the team at the University of Texas at Austin showed the virus is able to bind to human cells stronger than the SARS coronavirus but also noted the spike proteins can be targeted in the creation of a vaccine or treatment.

A vaccine, however, is still at least 18 months away. 

Feb. 17: Apple announced that the coronavirus outbreak would likely hurt its first-quarter revenue as factories were shuttered and fewer Chinese customers were purchasing iPhones.

“Work is starting to resume around the country, but we are experiencing a slower return to normal conditions than we had anticipated,” Apple said in a statement. “As a result, we do not expect to meet the revenue guidance we provided for the March quarter.”

Shigeru Omi, the chief director of the Japan Community Health Care Organization, suggested the Olympics could be disrupted or even canceled, depending on how the virus continues to spread and evolve over the next few months.

“Whether the virus is under control by the time of the Olympics is anyone’s guess,” he said.

Feb. 14: The US National Institute of Allergy and Infectious Diseases released new images of the virus for the first time. NIAID’s Rocky Mountain Laboratories in Montana used specialized equipment, scanning and transmission electron microscopes, to capture the digitally colorized close-ups.

Feb. 12: Mobile World Congress, the world’s largest trade show for the mobile industry, was canceled by the show’s organizer, the GSMA. The cancellation came after numerous big names including LG, Nvidia, Nokia, Vodafone, Amazon and Facebook announced they would be pulling out.

Chinese health authorities reported a jump in the number of cases and deaths in Hubei, the epicenter of the outbreak. Over 13,300 new cases were recorded in Hubei alone, an increase of 700% over the previous day. Chinese authorities had adopted a new clinical method for confirming cases, which saw them add “clinically diagnosed cases” to the count, potentially helping patients receive treatment sooner, according to CNN.

Feb. 11: The WHO officially named the disease caused by the novel coronavirus “COVID-19” (for coronavirus disease 2019.) That made things a little confusing, because the virus itself is not named COVID-19, but SARS-CoV-2.

Feb. 9: The outbreak reached a grim milestone: 811 deaths — more than the 2002-2003 SARS epidemic, which killed around 800 people.

Feb. 8: The first US citizen died from COVID-19 in Wuhan.

Feb. 7: Li Wenliang, the Chinese doctor who originally sounded the alarm about a spate of mysterious SARS-like illnesses in his WeChat group, died. He was 34.

Feb. 4: The Diamond Princess returned to port but Japanese health authorities were invited onboard to check the crew for signs of the coronavirus. It had 2,666 guests and 1,045 crew on board.

Feb. 2: The first death outside China was reported in the Philippines. A 44-year-old man from Wuhan with preexisting health conditions developed severe pneumonia and died at a hospital in Manila.

Feb. 1: A passenger who stayed aboard the Diamond Princess cruise from Yokohama, Japan, and disembarked in Hong Kong was confirmed to have the coronavirus. The ship was scheduled to return to port Feb. 4.

Jan. 30: The WHO declared a public health emergency of international concern. Tedros Adhanom Ghebreyesus, the director general of the WHO, said the organization was working with national and international public health partners to get the outbreak under control. It also issued recommendations to prevent the spread of the virus and ensure a “measured and evidence-based response.”

Jan. 28: 100 deaths were recorded in China, with most of them coming from Hubei province, the epicenter of the outbreak.

Jan. 24: Major attractions began closing down, including Disney Parks in Shanghai and Hong Kong. 

Jan. 23: China began to lock down cities including Wuhan, the epicenter of the outbreak. Public transport was suspended, as were flights and trains out of the city.  The travel restrictions were extended to four other cities (Huanggang, Ezhou, Chibi and Zhijiang) later that day, and constraints were announced in eight more cities on Jan. 24. Beijing canceled Lunar New Year plans, which were to begin Jan. 25.

Jan. 20: The first human-to-human transmission was reported by a Chinese expert on infectious diseases after two individuals caught the disease from family members and 14 health workers were infected by patients. This was a significant development in the spread of the virus and suggested cases could be much higher.

Jan. 16: Japan saw its first case of the virus, a man who had traveled to Wuhan.

Jan. 13: The first case outside China was reported by the WHO. A woman who had traveled from Wuhan to Thailand tested positive for the novel coronavirus.

Jan. 11: The first death was reported. A 61-year-old male with an underlying health condition who had visited the seafood market died from heart failure on Jan. 9.

Jan. 10: The genetic sequence of the isolated coronavirus was shared for the first time. In total, four sequences of the virus were shared by various Chinese research institutes. A team investigating the virus eventually published their research in the New England Journal of Medicine on Jan. 24.

Jan. 7: A novel coronavirus was identified from patients and given a placeholder name: 2019-nCoV. 

Jan. 1: China shut down the Huanan Wholesale Seafood Market in Wuhan, which was linked to a number of patients with the disease.

2019

Dec. 31: China alerted the WHO of a spate of illnesses in Wuhan, China. The central city lies some 650 miles south of Beijing and is home to more than 11 million people.

Dec. 30: Dr. Li Wenliang, a doctor at Wuhan Central Hospital, warned colleagues from his medical school via WeChat about a cluster of patients being treated for viral pneumonia, linking it to the SARS coronavirus. Investigations would later rule out that virus, which had caused an outbreak in 2002-2003.

Wenliang was reprimanded by Chinese authorities for speaking out about the mysterious illnesses he had seen at his hospital and was forced to sign a statement saying he was spreading rumors.

Dec. 1: The first patient experienced symptoms of the mysterious pneumonia-like illness now known as COVID-19. No epidemiological link was established between this case and later instances of the disease.

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[inhandnetworks-blog]

Zika Testing: Why the FDA Recommended It for All Blood Donated in U.S.

www.inhandnetworks.com

The U.S. Food and Drug Administration recommended on Friday that all blood donated in the United States and its territories be tested for Zika virus, as it moves to prevent transmission of the virus through the blood supply.

The agency said its decision to expand blood screening in the United States was based on concerns about more cases of local transmission in Florida, the growing number of travel-related infections and concerns that Zika-tainted blood could unwittingly be given to a pregnant woman, putting her unborn baby at risk of severe birth defects.

“The transfusion of a pregnant woman with blood infected with the Zika virus could have terrible consequences,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during a conference call with reporters.

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The current Zika outbreak was first detected in Brazil last year and has since spread across the Americas. In Brazil, Zika has been linked to more than 1,800 cases of microcephaly, and U.S. officials expect as many as 270 cases in Puerto Rico, where local transmission of the virus is widespread.

"Over 8,000 travel associated and over 2,000 non-travel associated cases of Zika have been reported in the United States and U.S. territories," Marks told reporters.

Given frequency of travel of individuals within the United States, he said there was a risk that people without symptoms of Zika could donate blood and transmit the virus.

Testing of donated blood is underway in Florida, Puerto Rico, as well as in other areas of the United States, and has been proven helpful in finding infected donations.

"About 1 percent of donations in Puerto Rico have tested positive for Zika virus," Marks said.

Such testing also helped spot one unit of Zika-tainted blood in the past few weeks. Marks said testing discovered the infected blood before it reached any patients.

FDA to Roll Out Testing in Stages

The Food and Drug Administration plans to roll out its recommendations in stages. In states and territories with local, mosquito-borne transmission, the recommendations will go into effect immediately. This affects Florida and Puerto Rico.

In 11 states near areas with local transmission or high rates of travel-related infections, the guidelines must be implemented within four weeks. These states include Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas.

For the rest of country, the guidelines must be implemented within 12 weeks.

Marks said Hologic Inc and Roche Molecular Systems had been granted special approval for their tests to be used to screen the blood supply.

Marks said the FDA had already reviewed data submitted by the companies and was confident these investigational tests would "perform appropriately” in this setting.

In addition to tests to check whole blood for Zika RNA, the agency said blood collection centers were permitted to use Cerus Corp's Intercept pathogen inactivation system in certain blood products, such as plasma.

America’s Blood Centers, a network of 63 blood centers with 600 donation sites in 45 U.S. states, is currently testing for Zika primarily in Florida, where local transmission has been reported. It also has centers testing in areas of Texas that are considered at high risk for the spread of the virus, and an affiliate in Arizona testing high-risk donors.

Dr. Louis Katz, chief medical officer for America’s Blood Centers, said it would take a “titanic” effort to implement testing in the first-tier states expected to be online in four weeks, but stressed the organization’s commitment to a safe blood supply.

“Testing labs and the test vendors are working feverishly to allow testing to start on time in the areas subject to the 12-week timeline,” he said in an email. “My conversations with the vendors suggest that if all goes smoothly that goal is feasible. Then, whether things go smoothly in an incredibly complex set of processes becomes critical.”

In March, the FDA granted Roche approval for a clinical trial testing its Zika blood screening test in Puerto Rico, where local blood donations had been halted and blood had to be imported from the continental United States.

The company said its second phase of deployment would be to prepare for blood donations in the southern United States.

OneBlood, a part of America’s Blood Centers network whose coverage area includes most of Florida and smaller parts of Alabama, Georgia and South Carolina, has been testing all collections for close to a month as part of the Roche trial, said Dr. Rita Reik, chief medical officer.

"We aren’t surprised, nor do we disagree, with the FDA guidance that just came out,” Reik said in a telephone interview.

The American Red Cross has been conducting blood tests for Zika as part of a clinical trial of aZika blood screening test made by Hologic and Grifols the FDA approved in June.

The trial involved five southeastern states believed to be at greatest risk for local Zikatransmission. Over the next two weeks, the Red Cross said it will expand this testing to four additional states in the south central and southwestern United States.

Hologic said in an emailed statement that the company has been ramping up for months and is confident it can meet the added demand from the FDA's guidance.

Shares of Hologic closed up 1 percent at $38.80 on Nasdaq.

Blood Transfusion Risk 'Is Really Low'

Dr. Alyssa Ziman, medical director of the clinical laboratories and transmission medicine at the University of California Los Angeles, said the new recommendations for Zika follow the similar steps the FDA took to protect the blood supply from the West Nile virus.

In that case, the FDA also had to rush out an unapproved test to detect the West Nile virus in the blood supply, Ziman said. Such tests are now approved.

"We are gathering data on the performance of the test while the test is in a sense being required by the FDA," she said.

Because the products are investigational, UCLA will need special permission from an independent ethics committee known as an Institutional Review Board, then each patient will need to sign a special consent form before receiving a transfusion.

Ziman said with the testing on top of the questioning already being done about people's travel histories to places where Zika is being spread, she believes the risk of getting Zika through a blood transfusion "is really low."

She said people who need a blood transfusion need to balance the risk of not getting transfused against their perceived risk of contracting Zika.

Vijay Kumar, an analyst for Evercor ISI, estimates that the FDA's recommendation for Zikauniversal testing "will add at least $30 million to revenues, which are likely to be split between Roche and Hologic."

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[ccrpsorg]

Virtual Clinical Trial

Clinical Research Remote Summary

A new method of collecting safety and efficacy data from clinical trial participants to from study start-up through execution. The trial takes full advantage of technologies and online social engagement platforms to conduct each stage with the comfort of the patient.

The COVID 19 pandemic has rapidly challenged the pharmaceutical industry to implement remote clinical research. The industry lacks extensive experience with distant methods of clinical trials. The opportunity for the remote clinical trial has been recognized for some time. The industry is making indoors with this operational paradigm. Remote data collection will not be feasible for all types of measurements. A decision tree should be defined to identify which clinical measure translates to candidate remote measurement. Regardless of the clinical to remote measurement pathway taken, several activities are required to ensure that the remote data that is collected is safe, usable, and valid. Attention must also be given to measurement frequency and schedule assessment for remote measurement. Many connected devices that can measure data can record it continuously. Collecting clinical trial assessment in remote mode is different and have their advantages as well as disadvantages.

  FDA guidance on remote monitoring 

FDA plays a crucial role in protecting the united states from threats such as emerging infections including pandemics such as coronavirus. FDA is issuing this guidance to provide general consideration to assist sponsors in assuring the safety of participants, maintains compliance, and minimizing risk to trial integrity. FDA guidance on the conduct of the clinical trial of the medical product during COVID-19 pandemic is important, in case to know about the drug safety or proper usage.

The progress of adopting a decentralized clinical trial model and remote data collection was limited before the COVID-19 pandemic. However, the rapid adoption of telehealth during COVID-19 when the remote doctor visits become vital. Remote monitoring clinical trials during COVID-19 become crucial. The rapid rate of adoption to remote measurements and sharing the experience and results can accelerate the field of clinical trials. During COVID-19 pandemic, many details still need to be figured out regarding remote monitoring. However, the current situation could be an opportunity to revamp the conventional clinical trial models.

   Virtual clinical trials can satisfy the need for vigorous clinical trials by using distributed technologies. Virtual clinical trials can reduce cost, shorten trial timelines, increase protocol adherence, and boost recruitment members and participants diversity. These trails provide access to the participant to the research team through a technology’s web portal. Although complete development regarding the collection of a lot of data. This approach holds growth potential. It is also critical in the social component of clinical trials along with the trust that can develop between participants and researchers. A VR based communication hub for VCT should reinsert some human of elements to these studies Use of VR to support interpersonal relation between participant and researchers are important for the single-blind study.

 . 

References: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency - FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7307062/ - Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487205/ - Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6969384/ - A Virtual Home for the Virtual Clinical Trial https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7051945/ - Conducting a Virtual Clinical Trial in HER2-Negative Breast Cancer Using a Quantitative Systems Pharmacology Model With an Epigenetic Modulator and Immune Checkpoint Inhibitors

#clinical research remote #clinical trials remote jobs #fda guidance on remote monitoring #remote monitoring clinical trials #remote monitoring clinical trials covid #fda guidance on conduct of clinical trials of medical products during covid-19 pandemic #remote monitoring clinical trials sop #virtual clinical trials #fda guidance remote consent

[ccrpsorg]

Principal Investigator Training - Role of Principal Investigator in Clinical Research

Principal Investigator

Principal Investigator Training - Advanced Principal Investigator Physician Certification (APIPC)™

CCRPS offers online principal investigator training to physicians interested in beginning a career as a PI or advancing their trial efficiency & outcomes. The principal investigator training course is designed for physicians seeking advanced review and understanding to assist in obtaining the knowledge needed for initial PI roles.

CCRPS courses are accredited by the Accreditation Council for Clinical Research & Education (ACCRE) and jointly accredited with PIMED by the American Medical Association (AMA) to provide 17.5 CME credits for physicians. ICH GCP and E6 certification (required Q3 years) is provided and recognized through meeting Transcelerate BioPharma requirements.

Because PI certification through examination (not required to conduct trials, but an asset to getting more sponsors/funding) requires at least 3,000 hours of experience as a principal investigator, physicians in our online principal investigator training program seek this course to assist in their positions as a PI. With CCRPS training physicians and PIs can function as a certified principal investigator.

The benefits of the PI training course is to improving efficiency, learning about multiple similar trials, and getting the fund of knowledge needed to improve quality, teamwork, and data.

While certification is not required for PIs to conduct trials, PI-sponsors and organization sponsors can show sponsors that PIs receive therapeutic-specific education and content-backed certification.

Most broadly, training can be another quality initiative to prevent trial errors. We teach in-depth with modules covering things like developing inclusion-exclusion criteria, writing protocols, etc. Our focus is on including multiple practical references, applications, and perspectives such that PIs can feel more comfortable making critical decisions in the trial.

Know that non-MDs/PharmDs can be a principal investigator if a physician is a co principal investigator.

Principal Investigator Definition

A Principal Investigator in Research is the primary individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research.

What is a principal investigator

PI principal investigator is responsible for the preparation, conduct, and completion of the research or project being funded by a grant or sponsor. This is increased by having additional educational training such as through CCRPS’s Advanced Principal Investigator Physician Certification (APIPC)™.

Principal Investigator Salary ranges heavily based on the physicians ability to manage both trials and their typical clinical caseload. While most MDs have a high salary from their career, running a trial can add between $37,000 to $279,000 as their additional clinical research principal investigator salary. Although this can be demanding, the reward of being able to offer new therapeutic advances to their patients is well worth it. Co Principal Investigator is a second physician helping assist in these duties usually for larger trials.

NIH principal investigator funding is best obtained by following and reviewing all of the resources available in the toolkit linked prior. See how to become a principal investigator at the NIH here.

Principal Investigator roles and responsibilities in clinical research

These are covered in the ICH GCP guidelines and are summarized below (Feehan, 2020):

Role of Principal Investigator in Clinical Research: Anyone qualified by training to run the trial; a physician or dentist must be listed as a sub-investigator if the principal investigator is not a physician

TO: Hire and train qualified individuals to run the trial AND

Protect subject safety: Protect subjects from harm, Keep track of drugs and distribute only as specified in the protocol, Obtain informed consent, Ensure IRB approval, Keep careful records and maintain them for as long as the protocol dictates or at least 2 years AND

Report: Progress, safety, financial, and a final report to the study sponsor, Adverse events; serious adverse events must be reported immediately, Update financial disclosures if any circumstances change during the study AND

Follow Form 1572: Strictly adhere to the protocol, Directly supervise the study and take responsibility for study staff, Inform subjects of experimental nature of the drug products, Report adverse events and stay updated on the investigational brochure, Maintain records, Ensure IRB compliance AND

Prepare for FDA inspections: Ensure all records are complete and easily accessible by FDA, Send a written response within 15 business days if any violations are found AND

Avoid violations: Read all communications from the IRB, Hire experienced staff and verify their credentials, Train staff regularly, Check for conflicts of interest/financial disclosures regularly, Write efficient protocols or reduce inefficiencies or confusing portions of the protocol, Keep regulatory binders up to date and conduct continuing reviews, Meet with the team regularly, Conduct several dry runs to ensure the study will run smoothly, Regularly check data processes

Download the FDA Principal Investigator roles and responsibilities powerpoint here.

PI Course Syllabus

Introduction

Accreditation Statement

CME Handout - How to Obtain 17.5 CME Credits through AMA/ACCME

Principal Investigator Toolkit

How to Effectively Use this Course

The Role Of The Principal Investigator

Principal Investigators Roles, Checklists, & GCP Guidelines

Principal Investigators Reporting Responsibilities for AEs and SAEs

FDA Form 1572 - Part 1

FDA Form 1572 - Part 2

Investigator Initiated Multi-Center Trials

Investigational Product Storage and Dispensing

Investigational Product Accountability in Clinical Trials

Clinical Trial Design & Protocol

Phases of Clinical Trials

Designs of Clinical Trials

Randomized Controlled Trials

Institutional Review Board (IRB)

The Clinical Trial Protocol - Advanced Mastery Review

Protocol Deviations and Violations

Inclusion and Exclusion Criteria in Clinical Research

IND Application

IND and NDA Process

Documents & Informed Consent

Source Documents and Informed Consent Forms

Informed Consent (ICH GCP Section 4.8)

Trial Management, Data Handling, and Record Keeping

Compliance with E-Signatures CFR 21 Part 11

Essential Regulatory Documents Guidance and Binder Tabs (Part 1)

Essential Regulatory Documents Guidance and Binder Tabs (Part 2)

Guidelines for Designing and Completing Case Report Forms

Do’s and Don’ts of a Case Report Form Design

Investigators Brochures

Trial Master File and DIA Model

Trial Master File Reference Guide

Financial Disclosure- Duties and Strategies for Clinical Studies

Financial Disclosures and Conflicts of Interest in Clinical Research

Adverse Events

Advanced Review of Adverse Events

Reporting of Adverse Events

Safety Reporting Requirements for Sponsor Investigators of An IND

Site Visits And Audits

Overview of Types of Monitoring Visits

Site and Investigator Selection

Site Selection/Qualification Visit (Pre-Study Visit)

Site Close Out Visit

Audits vs. Inspections

FDA Warning Letter

Site FDA Audit Inspection Checklist

How to Survive Through an FDA Inspection

Do and Don’ts during an FDA Inspection

Patient Safety, Recruitment, And Compliance

Introduction & History of ICH GCP

Compliance Requirements in Clinical Trials

Subject Recruitment and Retention (Part 1)

Subject Recruitment and Retention (Part 2)

Safety of Human Subjects in Clinical Research

Ethics of Research Involving Pregnant Women and Fetuses

Ethics of Research Involving Mentally Incapacitated

Ethics of Research Involving Children

Scientific Misconduct in Research and How to Prevent It

Increasing Subject Compliance in Clinical Trials

Misconduct in Research – Detecting Falsification

Self-Assessments

Self-Assessment MiniQuiz 1

Self-Assessment MiniQuiz 2

Self-Assessment Quiz A

Self-Assessment Quiz B

Final Quiz

How do I study for the course?

This course is extensive but that does not mean you need to review it like we may have for First Aid during Step 1. The course contains multiple checklists and references to help you get multiple angles of learning in order to understand the big picture of making the trials you run more efficient and successful.

At the end of the course, you should no memorize everything. Instead, run through this course and stop at checklists to see how they could be applied to your prior/future trials. Discussions are enabled so you can have a "social" way of jotting down notes to keep you engaged.

Online learning is tough, but this course should give you the references, checklists, and broad overview you may need to improve your trial (not remotely memorize protocols and document names). i.e. Look at images and diagrams to see what aspects pertain to you. Mark modules or screenshot checklists that you may want to use with your study coordinator.

In order to finish the course, you should skim each module and stop are parts that pertain to issues you may have with running the trial. Then take the mandatory final quiz to get certified. You can then get your 17.5 CME credits as well.

What does a PI need to run a trial?

-Examination rooms for conducting physicals and discussions with study subjects.

-Office equipment such as a computer with high speed internet access, fax machine, and telephone for patient scheduling and study correspondence.

-Phlebotomy and laboratory shipping materials storage area.

-A locked storage area for study materials and study medication.

-A locking calibrated refrigerator and freezer for lab samples (and potentially for study medication).

-Adequate working space for on-site visits from sponsor representatives or regulatory authorities.

-A secure storage area for archiving study records per regulatory requirements.

When should I take the ACRP PI Certification Exam?

CCRPS is not affiliated with ACRP. Our PI course covers the same industry-accepted topics as the ACRP PI certification exam to serve as an optional review course while gaining 17.5 CME credits. While the ACRP PI exam is not required, both this certification course and the ACRP exam (once you have 3,000 hours of experience) can be an asset in getting more sponsors/funding. Before you start the course, you can review the ACRP PI Exam Outline (see more detailed outline here) so you can use it as a tool to a) study the key concepts agreed upon by the industry during this course and also b) simultaneously prepared to sit for the ACRP PI exam.

How long is the course?

The course is fully self paced and be completed in as little as 2 week or over the course of a few months to cover all of the material. We like to provide comprehensive training materials so PIs can reference them at a later point but certification only requires the completion of self assessments, thus, certification can be completed as quickly as the assessments and self-review.

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