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0 0.5 1 1.5 2+ Symptomatic case 93% Improvement Relative Risk Case 93% c19regn.com Isa et al. NCT04519437 Casirivimab/i.. for COVID-19 RCT Prophylaxis Favors casirivimab/im.. Favors control
Isa, 969 patient casirivimab/imdevimab prophylaxis RCT: 93% fewer symptomatic cases [p=0.002] and 93% fewer cases [p=0.002] https://c19p.org/isa
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Repeat Subcutaneous Administration of REGEN-COV® in Adults is Well-Tolerated and Prevents the Occurrence of COVID-19
Isa et al., medRxiv, doi:10.1101/2021.11.10.21265889 (Preprint)
16 Nov 2021    Source   PDF   Share   Tweet
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.
Efficacy is variant dependent. Unlikely to be effective for omicron [Liu, Sheward, Tatham, VanBlargan].
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%), NNT 20, 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%), NNT 24, 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.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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, trial NCT04519437.
Contact: flonza.isa@regeneron.com.
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