April 27, 2020

Covid-19 roundup: FDA authorizes first at-home test for Covid-19

Daily Briefing

    NIH releases its first guidance on potential coronavirus treatments, health care companies turn to 3D printing to address testing and PPE shortages, and more.

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    • A study by Veterans Affairs researchers released last week found that the anti-malaria drug hydroxychloroquine was linked to higher rates of death in hospitalized Covid-19 patients. Of the 368 patients researchers followed for the study, 27% who were treated with hydroxychloroquine died, as well as 22% of patients who were treated with a combination of the hydroxychloroquine and an antibiotic. In comparison, 11.4% of patients who were not treated with hydroxychloroquine died. The researchers also found that hydroxychloroquine did not appear to have any benefits for Covid-19 patients on ventilators (Rowland, Washington Post, 4/21; Marchione, Associated Press, 4/21).

    • The World Health Organization (WHO) on Thursday accidentally published a draft summary of results of a clinical trial that suggested Gilead Sciences' experimental coronavirus treatment remdesivir did not benefit most patients with Covid-19. Further, the draft indicated that remdesivir was linked to side effects in Covid-19 patients, and that more patients who were treated with remdesivir died when compared with patients who were not treated with the drug—though the mortality differences were not statistically significant. WHO has since deleted the clinical trial results from its website, and Gilead spokesperson Sonia Choi said the results are "inconclusive" because the study ended early. Choi said Gilead felt "the post included inappropriate characterization of the study" and that "trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease" (Owermohle, Politico, 4/23; Silverman et al., STAT News, 4/23; Herman, Axios, 4/23; Owens, "Vitals," Axios 4/24).


    • FDA on Tuesday granted emergency use authorizations for the first at-home testing kit for the new coronavirus. The kit, which will be sold by LabCorp, comes with a nose swab that patients will use themselves to collect a sample and mail it back to LabCorp for testing. LabCorp said it is making the first batch of tests available to health care and emergency workers who either have symptoms of Covid-19 or may have been exposed to the new coronavirus. The company said the kits will be available to consumers in most states in "the coming weeks" (Thomas/Singer, New York Times, 4/21; Wang, Inside Health Policy, 4/21 [subscription required]).

    • An NIH panel has issued the agency's first guidelines on potential treatments for Covid-19. The panel in the guidelines warned there currently is not enough data to either support or rule out most potential treatments for the disease, but it advised against using some potential treatments, including the anti-malaria drug hydroxychloroquine and the HIV drug combination lopinavir and ritonavir, outside of clinical trials. The panel explained that those treatments haven't been linked to improved patient outcomes and have the potential to cause patients harm (Owermohle, Politico, 4/21; Grady, New York Times, 4/21; NIH release, 4/21).

    • Researchers at the University of South Florida Health and Northwell Health are collaborating with Formlabs to develop a 3D-printed swab that can be made at hospitals on-site, which could help to speed up mass testing efforts for the new coronavirus as the nation faces a shortage of nasal swabs used for such testing. Northwell said it plans to make up to 8,000 swabs per day with 3D printers (Repko, CNBC, 4/22).

    • Researchers at Northwestern University have developed a new 3D-printing technique that allows them to generate more than 1,000 protective face shields for health care workers per day. Chad Mirkin and David Walker, researchers at the university, in an article published last year in the journal Science revealed that the printing technique, called high-area rapid printing, can print half a yard in an hour. Mirkin said a team of researchers decided to use the printing method to create face shields to address the shortage of PPE due to the new coronavirus epidemic (Morris, Northwestern University release, 3/29).

    • UVA Health is using a new robot to help health care workers disinfect PPE. The robot uses UV sources to disinfect up to 6,000 N95 masks per day. UVA said it was able to train staff to use the robot within five days, and UVA Health officials said the robot will help address a shortage of PPE throughout the hospital (Swensen, UVA Today, 4/10).

    • UnitedHealth Group, Boston Scientific, Medtronic, and the University of Minnesota on Thursday announced they are collaborating to distribute 3,000 "light" ventilators to health care facilities that do not have "immediate access to traditional ventilators." The organizations said they are sending the first 500 units of the ventilator, called the Coventor, this week to regions that are experiencing extreme ventilator shortages. (Daily Briefing is published by Advisory Board, a division of Optum, which is a wholly owned subsidiary of UnitedHealth Group) (O'Brien, HealthLeaders Media, 4/23; UnitedHealth Group release, 4/23).

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