NIH Launches Effort To ID Promising COVID-19 Treatments For Clinical Trials
Staff Contact: Terrie Bauer
The National Institutes of Health announced a study designed to identify promising COVID-19 therapies and investigational drugs that merit larger clinical trials. The ACTIV-5 Big Effect Trial, which will enroll adult volunteers hospitalized with COVID-19 at as many as 40 U.S sites, will be administered by the National Institute of Allergy and Infectious Diseases in collaboration with NIH’s public-private Accelerating COVID-19 Therapeutic Innovations and Vaccines partnership. NIH said the phase 2 adaptive, randomized, double-blind, placebo-controlled trial will compare different investigational therapies to a common control arm to determine which experimental treatments have relatively large effects, with approximately 100 hospitalized volunteers assigned to each study arm.
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FDA Authorizes COVID-19 Antibody Test’s Emergency Use
Staff Contact: Terrie Bauer
The U.S. Food and Drug Administration issued an emergency use authorization for Abbott Laboratories’ AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test. Abbott said the test, which is used on its ARCHITECT and Alinity platforms, has demonstrated high reliability in its research and external virology laboratory studies, with 99.56% specificity and 95% sensitivity for patients tested 15 days after symptom onset.
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HHS, DOD Award $481 Million For Point-Of-Care Test, Announce Vaccine Manufacturer Partnership
Staff Contact: Terrie Bauer
The U.S. Department of Health and Human Services and the Department of Defense awarded $481 million to Cue Health, Inc. to expand production of a point-of-care COVID-19 molecular test with capabilities to produce results in 20 minutes. Cue said the highly sensitive test uses a nasal swab sample to detect RNA of SARS-CoV-2, the virus that causes COVID-19. HHS said the partnership allows Cue to increase production to 100,000 test kits per day by March 2021.
HHS and DOD announced a separate $31 million agreement with Cytiva to expand the company’s capacity to produce items essential to the production of COVID-19 vaccines, such as liquid and dry powder cell culture media, cell culture buffers, mixer bags and bioreactors.
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