May 21, 2020

Covid-19 roundup: CDC announces nationwide Covid-19 antibody study

Daily Briefing

    FDA approves a second at-home testing kit, a cigarette company seeks approval for an experimental vaccine, and more.

    Covid-19 weekly webinar: What health care leaders need to know

    • A study published last week in Medrxiv found that convalescent plasma therapy, which involves administering blood plasma transfusions from recovered Covd-19 patients to current Covid-19 patients, is safe for treating Covid-19, the disease caused by the new coronavirus. The study, which examined 5,000 hospitalized Covid-19 patients, revealed there were no excessive mortalities and few serious side effects associated with the treatment. Researchers from Mayo Clinic, Michigan State University, and Johns Hopkins University who were behind the study said the results could pave the way for future clinical trials involving the treatment. The study was not peer reviewed before it was published (Marcus, Wall Street Journal, 5/14).
    • CDC plans to launch a nationwide study this summer to track the spread of the novel coronavirus, an agency spokesperson told Reuters. Michael Busch, director of Vitalant Research Institute who is leading a preliminary version of the study, said the study will be conducted in 25 metropolitan areas. The study is expected to include 325,000 participants over the course of 18 months and will examine how antibodies for the new coronavirus evolved over time (Brown, Reuters, 5/18).
    • Cigarette company British American Tobacco (BAT) on Friday said its experimental coronavirus vaccine that uses proteins from tobacco leaves showed promise in pre-clinical trials. The company said it is seeking approval from FDA to move the vaccine into Phase 1 trials. BAT in April said it could produce one million to three million doses of the vaccine per week with support from government agencies (Cavale, Reuters, 5/15).
    • FDA has temporarily halted an at-home coronavirus testing program being tested in Seattle. The Seattle Coronavirus Assessment Network (SCAN) said FDA requested the organization pause its research, saying a "separate federal emergency use authorization (EUA) is required to return results for self-collected tests." SCAN on Saturday said it was working with regulators to resume the program (Axelrod, The Hill, 5/15; Ponnezhath/Heavey, Reuters, 5/16).
    • FDA on Saturday granted an EUA for Everlywell's at-home coronavirus testing kit. The kit allows individuals to perform a nasal swab at home and send the sample to a laboratory for diagnostic testing. The testing kits, which cost $135 each, will be available by the end of May. This is the second at-home coronavirus test to receive an EUA, according to the New York Times (Kaplan, New York Times, 5/16).
    • FDA on Tuesday announced it is collaborating with health tech startup Aetion to launch a research project focused on analyzing "real-world" Covid-19 data, STAT News reports. The project will focus on data from insurance companies and EHRs and aims to help researchers learn more about how best to study the disease (Herper, STAT News, 5/19).
    • Gilead Sciences has increased the number of doses of remdesivir, its experimental Covid-19 treatment, it will donate to the federal government, according to a letter an HHS official sent to governors Saturday. According to the letter, Gilead plans to increase the number of donated doses from 607,000 to 940,000. STAT News reports that the 300,000 extra doses could treat between 30,000 and 55,000 additional patients (Boodman, STAT News, 5/18).
    • NIH has started a clinical trial that will study whether the combination of the anti-malaria drug hydroxychloroquine and the antibiotic azithromycin could be an effective Covid-19 treatment. The study will test the combined drug therapy in 2,000 adult patients with Covid-19 (Hellmann, The Hill, 5/14).
    • UnitedHealth Group (UHG) and Microsoft have partnered to launch a smartphone app that allows employers to screen workers for symptoms of Covid-19. The app, called ProtectWell, asks users a series of questions that screen them for exposure to the new coronavirus or symptoms of Covid-19. Employees who may be infected with the virus then can be referred for diagnostic testing. The app, which is available to employers at no cost, is designed to help employers determine which workers to bring back to the office as states reopen nonessential businesses and ease social distancing measures. (Daily Briefing is published by Advisory Board, a wholly own subsidiary of UHG) (Livingston, Modern Healthcare, 5/15; Japsen, Forbes, 5/15; UHG release, 5/15).
    • University Hospitals has partnered with the Manufacturing Advocacy and Growth Network (MAGNET) to develop protective booths for coronavirus testing. The booths allow health workers to administer tests for the new coronavirus using gloves attached to a barrier on the booth. David Sylvan, president of UH Ventures, said the barriers will protect patients and health workers from the virus. The development also could reduce personal protective equipment (PPE) usage, since workers will not have to change PPE between each test (WSKU, 5/14).

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