The Johns Hopkins Bloomberg School of Public Health launches a no-cost contact tracing course open to the public, Twitter begins alerting users when tweets might include misleading or disputed claims about the new coronavirus, and more.
- FDA last week issued an emergency use authorization (EUA) allowing Quidel to distribute its rapid antigen test for the new coronavirus. While providers commonly use antigen tests to screen patients for infections such as influenza or strep throat, Quidel's new antigen test is the first specifically tailored to the new coronavirus. For the test, providers use a nasal swab to collect a sample from a patient and can run the test immediately, getting results within 15 minutes. The EUA allows providers to administer the tests in a doctor's office or other point-of-care location. Quidel last week said it already had begun shipping the antigen test kits to customers (Mettler, Washington Post, 5/9).
- FDA in a guidance document released Monday called on drugmakers to study potential antiviral treatments for Covid-19, the disease caused by the new coronavirus, via randomized, placebo-controlled trials and include individuals with high-risk conditions and renal impairment in the trials. In addition, FDA urged drugmakers to ensure elderly individuals and racial and ethnic minorities are represented in such trials. FDA said the guidance will remain in effect until the federal government lifts the national public health emergency regarding Covid-19 (Wang, Inside Health Policy, 5/12 [subscription required]).
- Gilead Sciences has signed agreements with five generic drugmakers in India and Pakistan to manufacture and distribute its promising Covid-19 treatment remdesivir in 127 countries. Under the agreements, the companies will be able to set their own prices for remdesivir, but they will not have to pay royalties to Gilead until the World Health Organization ends its public health emergency declaration for Covid-19 or until another medication is approved to prevent or treat the disease (Silverman, "Pharmalot," STAT News, 5/12).
- The Johns Hopkins Bloomberg School of Public Health on Monday launched a new, online course that teaches people about contact tracing for the new coronavirus. The six-hour course informs students about the origins of the new coronavirus, the clinical signs of Covid-19, the purpose of quarantines, communication skills for contact tracing, and ethics and privacy standards for contact tracing. New York is requiring the course for individuals hired as contact tracers in the state, but the school has made the course available to the public, including individuals outside of New York and those who have not been hired as contact tracers, at no cost (West, Wall Street Journal, 5/11; Guarino, Washington Post, 5/11).
- Researchers from Massachusetts General Hospital (MGH) and London-based King's College used a symptom-checker app from Zoe Global to predict cases of Covid-19 with 80% accuracy, according to a study published Monday in Nature. The researchers found that loss of smell and taste were the top symptoms associated with individuals who developed Covid-19. Andrew Chan, MGH's chief of clinical and translational epidemiology and the lead investigator on the study, said the app could help public health officials identify individuals who are in the early stages of Covid-19 and may be unaware they have the disease (Drees, Becker's Health IT, 5/12; Jacobs, New York Times, 5/11).
- Moderna on Tuesday announced that FDA has granted the company a fast-track designation for its potential vaccine against the new coronavirus. The designation aims to accelerate the regulatory approval process for new treatments and vaccines. Moderna currently is testing the potential vaccine, called mRNA-1273, in phase 1 clinical trials and is preparing to launch phase 2 and phase 3 trials soon (Adams, FierceBiotech, 5/12; Grossman, Dow Jones/Wall Street Journal, 5/12).
- NIH last week announced that it has started a randomized, controlled clinical trial to examine whether a combination of Gilead's remdesivir and an anti-inflammatory drug known as baricitinib can be used to treat Covid-19. NIH said it is working to enroll more than 1,000 hospitalized, U.S. patients with Covid-19 in the trial. Anthony Fauci, director of NIH's National Institute of Allergy and Infectious Diseases, said data has shown "that remdesivir diminishes to a modest degree the time to recovery for people hospitalized with Covid-19," and the new trial seeks to determine whether treating patients with both baricitinib and remdesivir will produce additional benefits, including reducing the mortality rate among such patients (Reuters, 5/8).
- Science 37, a company that uses telehealth tools to facilitate virtual clinical trials, has partnered with AiCure, a medication adherence company, to help ensure clinical trials continue running during America's Covid-19 epidemic. The companies aim to help researchers recruit and enroll clinical trial participants, track participants' progress remotely, and connect participants with researchers and providers via telemedicine (Reuter, MedCity News, 5/10).
- Twitter on Monday announced it will alert users when a tweet includes misleading or disputed claims about the new coronavirus. Some tweets will feature a label positioned underneath the tweet that directs users to a page with information about Covid-19, while other tweets may be covered entirely with a warning stating that "some or all of the content shared in this tweet conflict with guidance from public health experts regarding Covid-19," the company said. Twitter said it will determine which tweets will include the alert (Seitz, Associated Press, 5/11; Wells, Wall Street Journal, 5/11).