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Casirivimab/imdevimab study #14   All Outcomes
0 0.25 0.5 0.75 1 1.25 1.5 1.75 2+ Symptomatic case 93% Imp. Relative Risk, 95% CI Case 93% Isa: Repeat Subcutaneous Administration of REGEN-COV® in Adul.. c19regn.com/isa.html Favors casiri/imdevimab Favors control
11/16 Prophylaxis study
Isa et al., medRxiv, doi:10.1101/2021.11.10.21265889 (Preprint)
Repeat Subcutaneous Administration of REGEN-COV® in Adults is Well-Tolerated and Prevents the Occurrence of COVID-19
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RCT 969 patients, 729 treated with monthly subcutaneous casirivimab/imdevimab, showing significantly lower risk of COVID-19 with treatment. There were no grade 3 injection site reactions or hypersensitivity reactions. Slightly more TEAEs were reported with treatment (54.9% vs. 48.3%), due to grade 1-2 ISRs. Serious adverse events were rare and occurred with similar percentages for treatment and control groups. There were no deaths. NCT04519437.
risk of symptomatic case, 92.6% lower, RR 0.07, p = 0.002, treatment 3 of 729 (0.4%), control 13 of 240 (5.4%), odds ratio converted to relative risk.
risk of case, 92.7% lower, RR 0.07, p = 0.002, treatment 0 of 729 (0.0%), control 10 of 240 (4.2%), odds ratio converted to relative risk, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), seroconversion.
Conflicts of interest: employee of the drug patent holder.
Isa et al., 11/16/2021, Double Blind Randomized Controlled Trial, USA, North America, preprint, 31 authors.
Contact: flonza.isa@regeneron.com.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. For an individual study the most serious outcome may have a smaller number of events and lower statistical significance, however this provides the strongest evidence for the most serious outcomes when combining the results of many trials.
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