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November 30, 2020

Covid-19 roundup: FDA approves first at-home Covid-19 test

Daily Briefing

    Below we round up the latest news on efforts to combat the Covid-19 epidemic

    • AdventHealth last week announced it will partner with biotechnology company Berg on a project to better identify treatments for people with Covid-19. The companies will use medical record data from AdventHealth to develop a biobank of Covid-19 patients. They will then use artificial intelligence developed by Berg to analyze the data and identify Covid-19 treatments that produced better outcomes in specific patient groups, such as those with certain comorbidities or those of the same race or ethnicity. The companies hope to use the data to develop decision-support tools to help clinicians treat Covid-19 patients (Kim Cohen, Modern Healthcare, 11/23).
    • FDA earlier this month issued an emergency use authorization (EUA) for Lucira Health's Covid-19 All-In-One Test Kit, which is an at-home coronavirus test that can be used to screen people who are at least 14 years old for the virus. According to FDA, the test works "by swirling the self-collected sample swab in a vial that is then placed in the test unit." The test provides results on a light-up display within 30 minutes, FDA said. As of now, FDA has authorized the test only for prescription use (Folley, The Hill, 11/17; Romo, NPR, 11/17; Armus/Kornfield, Washington Post, 11/18; Wu, New York Times, 11/18).
    • FDA earlier this month also issued an EUA for the first serology test that is able to screen samples for antibodies generated by a previous novel coronavirus infection. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at FDA's Center for Devices and Radiological Health, said while it's still not known whether antibodies generated by a previous infection can generate immunity to the new coronavirus, the new serological test will help researchers study neutralizing antibodies that "can help us gain additional insight into what the existence of antibodies may mean for patients" (Feuer, CNBC, 11/6).
    • FDA earlier this month issued an EUA for baricitinib, Eli Lilly's antibody drug, to be used alongside remdesivir as treatment for Covid-19 patients. The authorization is for the treatment of hospitalized adult and pediatric patients at least two years old, who need supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (Reuters, 11/19; Wang, Inside Health Policy [subscription required], 11/19).
    • FDA earlier this month granted an EUA for the experimental antibody cocktail developed by Regeneron that was given to President Trump after he was diagnosed with Covid-19. The drug, a one-time treatment administered through an IV, utilizes two antibodies that have been shown in earlier studies to reduce medical visits in Covid-19 patients who receive the drug early on in their treatment. Under the EUA, the drug can be used to treat adults and children 12 and older who are at high risk of developing severe Covid-19 and weigh at least 88 pounds (Thomas/Weiland, New York Times, 11/21; McGinley/Johnson, Washington Post, 11/21; Marchione, Associated Press, 11/21).
    • Fitbit is testing an algorithm it developed for its wearable devices to see whether the devices are able to detect cases of coronavirus infection early, utilizing a person's breathing rate, resting heart rate, and heart rate variability. Fitbit plans to test the algorithm in a study conducted in partnership with Northwell Health's Feinstein Institutes for Medical Research. Meanwhile, a study published in Nature earlier this month by researchers at the Scripps Research Translational Institute found that wearables could help to detect coronavirus cases by monitoring sleep changes, as well as changes in activity levels and heart rate alongside symptom data. Using data on 30,500 people, including 3,811 who reported having Covid-19 symptoms and 54 who tested positive for the novel coronavirus, researchers developed an algorithm that was able to identify a patient who was likely to be infected with the virus based on their symptoms with 80% accuracy (Reuter, MedCity News, 10/29; Reuter, MedCity News, 11/1).
    • Earlier this month, a panel from the World Health Organization in a revised guidance published in the BMJ said it now has a "weak or conditional recommendation" against the use of remdesivir for treating hospitalized Covid-19 patients. The panel said data from four international clinical trials comparing the use of several drug treatments for Covid-19 found that remdesivir "has no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement" (Joseph, STAT News, 11/19; Walker, Wall Street Journal, 11/19; Carey, New York Times, 11/19).
    • A study from Oxford University suggests that recovered Covid-19 patients are "highly unlikely" to contract the new coronavirus for at least six months. For the study, which has yet to be peer-reviewed, researchers looked at 12,180 health care workers over a 30-week period between April and November. Throughout the study period, all of the workers were tested for new coronavirus antibodies and for Covid-19. The researchers found that just 89 of the 11,052 workers without coronavirus antibodies developed a new infection of the virus with symptoms—however, none of the 1,246 workers with coronavirus antibodies developed a symptomatic case of Covid-19, and those with antibodies were found to be less likely to test positive for an asymptomatic case of Covid-19 (Meredith, CNBC, 11/20).
    • In a recent study published in Science, researchers found that 10% of the nearly 1,000 Covid-19 patients studied who developed life-threatening pneumonia had antibodies known as autoantibodies, which disabled immune system proteins called interferons. The researchers did not find the autoantibodies in any of the 663 participants with mild Covid-19 or asymptomatic coronavirus infections, though they did find the autoantibodies in four of the 1,227 healthy participants. In addition, the researchers in a second study also published in Science found that 3.5% of participants who were critically ill with Covid-19 had mutations in the genes controlling interferons that fight viruses (Szabo, Kaiser Health News, 11/13).
    • A recent study that has yet to be peer-reviewed or published in a scientific journal suggests that people who have recovered from a novel coronavirus infection may have enough immune cells to combat the virus for as long as eight months after their initial infection clears. Meanwhile, a separate study published earlier this month in Nature found that patients who have recovered from a novel coronavirus infection developed powerful, killer immune cells even if antibodies to the virus aren't detectable (Mandavilli, New York Times, 11/17).

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