FDA approves the first saliva-based Covid-19 test, new data on Gilead's experimental Covid-19 treatment, and more.
- A study published Friday in the New England Journal of Medicine found that two-thirds of a small group of patients with severe cases of Covid-19, which is the disease caused by the new coronavirus, showed improvement after being treated with Gilead Sciences' remdesivir, which researchers were testing as an experimental treatment for Covid-19 through a compassionate use trial. According to the study, 36 out of 53 patients in the trial showed improved oxygen levels on the drug, while 17 other patients were able to be taken off ventilators. Researchers will now begin conducting controlled clinical trials on the drug (Rowland, Washington Post, 4/10).
- Beaumont Health has said it will test all employees for novel coronavirus antibodies to determine who has been infected and therefore may be immune to the virus. The Michigan-based health system intends to test blood samples from 38,000 employees and thousands of physicians and affiliates, which could make the initiative the largest Covid-19 antibody test in the country. Beaumont officials said participation in the program is voluntary (Harris, Washington Post, 4/13).
- Eli Lilly on Friday announced it has initiated clinical testing of potential therapies for Covid-19. The drugmaker said it will start testing baricitinib, a drug used to treat atopic dermatitis, in the United States this month and that it will later expand testing to Asia and Europe. The company said it likely will have initial results from the study within two months (Singh, Reuters, 4/10).
- FDA on Friday warned consumers against using the veterinary anti-parasitic drug ivermectin as a treatment for Covid-19. FDA made the announcement to address reports of a yet-to-be-published study that found ivermectin prevented the new coronavirus' replication in a lab setting. FDA cautioned that researchers did not test ivermectin in animals or humans for the study, and said more testing will be needed to determine whether ivermectin could be effective at treating Covid-19 in humans (Tan, Washington Times, 4/11).
- In addition, FDA on Friday announced that it has granted Emergency Use Authorization (EUA) for a blood purification system to treat patients infected with the new coronavirus who are at least 18 years old and have been admitted to the ICU with respiratory failure. The purification process is intended to reduce the amount of pro-inflammatory cytokines in a patient's blood, which FDA said could reduce severe immune responses, often referred to as cytokine storm, to Covid-19. The system's EUA will remain in effect for the duration of the United States' Covid-19 epidemic (Wang, Inside Health Policy, 4/10 [subscription required]).
- FDA on Monday also granted EUA for the first saliva-based Covid-19 test. For the test, developed at the Rutgers University lab RUCDR Infinite Biologics, patients will spit in a tube that they will then give to health professionals for testing. Health experts say the test will increase safety for health care workers performing the tests. The tests will be available in hospitals and clinics associated with the university (Coleman, The Hill, 4/13).
- Also on Monday, FDA published new guidance regarding hydroxychloroquine sulfate and chloroquine phosphate that could encourage the development of generic versions of the drugs, as researchers evaluate whether the therapies are effective at treating Covid-19. The guidance could allow some sponsors to skip in vivo studies for the drugs and could provide drugmakers with information that could help them start or speed up drug development (Wang, Inside Health Policy, 4/13 [subscription required]).
- HHS through a partnership with UnitedHealth Group on Friday started delivering $30 billion in relief funds to providers that were allocated under a recently enacted $2 trillion stimulus package. The funds aim to reimburse providers for Covid-19-related expenses and to ensure uninsured Americans can access testing and treatment for Covid-19 without receiving inflated bills for the services. HHS said it has yet to determine how it will distribute the remaining $70 billion in funds, but noted that it will prioritize distributing remaining funds to providers in Covid-19 hot zones, rural providers, and providers that serve Medicaid populations. Daily Briefing is published by Advisory Board, a division of Optum, which is a wholly owned subsidiary of UnitedHealth Group (HHS release, 4/10; Cohrs, Modern Healthcare, 4/10; King, FierceHealthcare, 4/10).
- The Yale School of Public Health and Amazon Web Services are partnering with Volunteer Surge to train one million volunteer health care workers online in Covid-19 care. After completing a 30-hour online community health worker course, volunteers will be certified to assist with drive-thru testing sites, take patients' vital signs in tent triage centers, and assist home-bound patients over the telephone (Drees, Becker's Hospital Review, 4/10).