Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Horby et al., The Lancet, doi:10.1016/S0140-6736(22)00163-5, Jun 2021 (preprint)

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https://c19early.org/recoveryr.html

Casirivimab/imdevimab

17th treatment shown to reduce risk in March 2021, now with p = 0.00018 from 33 studies, recognized in 52 countries. Efficacy is variant dependent.

Lower risk for hospitalization, progression, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine treatments.

5,600+ studies for 131 treatments. c19early.org

RCT 9,785 hospitalized patients in the UK showing lower mortality with casirivimab/imdevimab, with statistical significance reached for baseline seronegative patients.

Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for many omicron variants1-7.

Standard of Care (SOC) for COVID-19 in the study country, the United Kingdom, is very poor with very low average efficacy for approved treatments8. The United Kingdom focused on expensive high-profit treatments, approving only one low-cost treatment, which required a prescription and had limited adoption. The high-cost prescription treatment strategy reduces the probability of treatment—especially early—due to access and cost barriers, and eliminates complementary and synergistic benefits seen with many low-cost treatments. This may explain in part the very high mortality seen in this study. Results may differ in countries with improved SOC.

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risk of death, 6.0% lower, RR 0.94, p = 0.16, treatment 943 of 4,839 (19.5%), control 1,029 of 4,946 (20.8%), NNT 76, all patients.

risk of mechanical ventilation, 1.0% higher, RR 1.01, p = 0.88, treatment 484 of 4,556 (10.6%), control 488 of 4,642 (10.5%), all patients.

risk of death, 21.0% lower, RR 0.79, p = 0.001, treatment 396 of 1,633 (24.2%), control 452 of 1,520 (29.7%), NNT 18, seronegative patients.

risk of mechanical ventilation, 13.0% lower, RR 0.87, p = 0.13, treatment 190 of 1,599 (11.9%), control 202 of 1,484 (13.6%), NNT 58, seronegative patients.

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

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

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

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

4. Tatham et al., 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, bioRxiv, doi:10.1101/2022.01.23.477397.biorxiv.org, doi.org.

5. Pochtovyi et al., In Vitro Efficacy of Antivirals and Monoclonal Antibodies against SARS-CoV-2 Omicron Lineages XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1, Vaccines, doi:10.3390/vaccines11101533.mdpi.com, doi.org.

6. Haars et al., Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023, Microorganisms, doi:10.3390/microorganisms11102417.mdpi.com, doi.org.

7. Uraki et al., Antiviral efficacy against and replicative fitness of an XBB.1.9.1 clinical isolate, iScience, doi:10.1016/j.isci.2023.108147.sciencedirect.com, doi.org.

8. c19early.org, c19early.org/soc/united-kingdom.html.c19early.org/soc/united-kingdom.html.

Horby et al., 16 Jun 2021, Randomized Controlled Trial, United Kingdom, peer-reviewed, 32 authors, study period 18 September, 2020 - 22 May, 2021, average treatment delay 9.0 days.

This Paper Casirivimab/i..All

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Late treatment
is less effective

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