bamlanivimab monotherapy (n=588) vs. placebo (n=587)
randomized controlled trial
some concerns about risk of bias
Bamlanivimab
Single intravenous infusion of bamlanivimab 4200mg.
Placebo
COVID-19 prophylaxis (excluding children)
All participants were aged 18 years or older and had no known history of COVID-19. Participants provided both nasal and nasopharyngeal swabs (baseline samples) for detection of SARS-CoV-2 by reverse transcriptase–polymerase chain reaction (RT-PCR) and blood samples for SARS-CoV-2 serology tests.
Double-blind.
74 facilities in the United States.
The evaluation period was 8 weeks, with follow-up to 24 weeks. Mild or worse disease severity included mild, moderate, severe, and critical disease severity and death due to COVID-19. The trial enrolled residents and staff at 74 skilled nursing and assisted living facilities in the United States (California, Colorado, Florida, Illinois, Indiana, Kentucky, Missouri, North Carolina, Ohio, Pennsylvania, and Virginia). All 74 facilities had at least 1 confirmed SARS-CoV-2 index case.
EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly. < Study carried out before the release of the omicron variant >