New phase 3 analyses show that a single dose of REGEN-COV® (casirivimab and imdevimab) provides long-term protection against COVID-19

Regeneron Press Release (News), NCT04452318 (history)

Regeneron, New phase 3 analyses show that a single dose of REGEN-COV® (casirivimab and imdevimab) provides long-term.., Press Release (News), NCT04452318

Nov 2021 Source PDF

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Long-term results for PEP RCT NCT04452318 (history), with 841 baseline seronegative casirivimab/imdevimab patients and 842 placebo patients, showing significantly lower cases with treatment.

Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron [Liu, Sheward, Tatham, VanBlargan].

1. Liu et al., bioRxiv, doi:10.1101/2021.12.14.472719, Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2, https://www.biorxiv.org/content/10.1101/2021.12.14.472719.

2. Sheward et al., bioRxiv, doi:10.1101/2021.12.19.473354, Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron), https://www.biorxiv.org/content/10.1101/2021.12.19.473354.

3. Tatham et al., bioRxiv, doi:10.1101/2022.01.23.477397, Lack of Ronapreve (REGN-CoV; casirivimab and imdevimab) virological efficacy against the SARS-CoV 2 Omicron variant (B.1.1.529) in K18-hACE2 mice, https://www.biorxiv.org/content/10.1101/2022.01.23.477397.

4. VanBlargan et al., bioRxiv, doi:10.1101/2021.12.15.472828, An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies, https://www.biorxiv.org/content/10.1101/2021.12.15.472828v1.

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risk of hospitalization, 92.3% lower, RR 0.08, p = 0.03, treatment 0 of 841 (0.0%), control 6 of 842 (0.7%), NNT 140, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), 8 months.

risk of case, 81.5% lower, RR 0.19, p < 0.001, treatment 20 of 841 (2.4%), control 108 of 842 (12.8%), NNT 9.6, months 1-8.

risk of case, 81.6% lower, RR 0.18, p < 0.001, treatment 7 of 841 (0.8%), control 38 of 842 (4.5%), NNT 27, months 2-8.

risk of hospitalization/ER, 88.9% lower, RR 0.11, p = 0.06, treatment 0 of 753 (0.0%), control 4 of 752 (0.5%), NNT 188, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 29.

risk of symptomatic case, 81.4% lower, RR 0.19, p < 0.001, treatment 11 of 753 (1.5%), control 59 of 752 (7.8%), NNT 16, day 29.

recovery time, 62.5% lower, relative time 0.37, p < 0.001, treatment 753, control 752, short-term followup, relative time with symptoms.

time to viral-, 69.2% lower, relative time 0.31, p < 0.001, treatment 753, control 752, short-term followup, relative time with high viral load.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Regeneron et al., 8 Nov 2021, Double Blind Randomized Controlled Trial, multiple countries, preprint, 1 author, trial NCT04452318 (history).

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