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bamlanivimab monotherapy (n=588) vs. placebo (n=587)
randomized controlled trial
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 >
casirivimab/imdevimab (Ronapreve) (n=753) vs. placebo (n=752)
randomized controlled trial
REGEN-COV (casirivimab 600mg plus imdevimab 600mg)
Single dose of REGEN-COV 1200 mg at day 1 via subcutaneous injection.
Placebo
Placebo at day 1 via subcutaneous injection.
COVID-19 prophylaxis (excluding children)
Double-blind.
112 sites in the US, Romania and Moldova.
The trial consists of a 1-day screening/baseline period, a 28-day efficacy assessment period (EAP), and a 7-month follow-up period.
*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.*
cilgavimab and tixagevimab (Evusheld) (n=3460) vs. placebo (n=1737)
randomized controlled trial
tixagevimab (AZD8895) and cilgavimab (AZD1061)
single dose (two consecutive intramuscular injections, one containing tixagevimab and the other containing cilgavimab) of 300 mg of AZD7442
placebo
COVID-19 prophylaxis (excluding children)
double-blind
87 sites in the US, UK, Spain, France and Belgium
*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.* preliminary results reported in a press release https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-prophylaxis-trial-met-primary-endpoint.html
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