All Studies Meta Analysis

Sotrovimab versus usual care in patients admitted to hospital with COVID-19: a randomised, controlled, open-label, platform trial (RECOVERY)

Horby et al., medRxiv, doi:10.1101/2025.01.24.25321081

Jan 2025

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Sotrovimab for COVID-19

40th treatment shown to reduce risk in August 2022, now with p = 0.0016 from 27 studies, recognized in 38 countries. Efficacy is variant dependent.

Lower risk for mortality, ICU, and hospitalization.

No treatment is 100% effective. Protocols combine treatments.

5,300+ studies for 115 treatments. c19early.org

RCT 1,723 hospitalized COVID-19 patients showing lower 28-day mortality with sotrovimab in patients with high serum nucleocapsid antigen levels, but no significant benefit in the overall population. Sotrovimab reduced mortality from 29% to 23% in high-antigen patients, however there was no significant difference in the overall population (21% vs. 22%; rate ratio 0.95; 95% CI 0.77-1.16; p=0.60). The trial used a higher dose of sotrovimab (1g) due to reduced neutralization activity against Omicron BA.1, and no new safety concerns were identified.

Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.11-3, BA.4, BA.54, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.15, and no efficacy for BA.26, XBB, XBB.1.5, ХВВ.1.9.17, XBB.1.16, BQ.1.1.45, and CL.15. US EUA has been revoked.

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risk of death, 5.0% lower, HR 0.95, p = 0.64, treatment 177 of 828 (21.4%), control 201 of 895 (22.5%), NNT 92, all patients, Cox proportional hazards.

risk of death, 25.0% lower, HR 0.75, p = 0.047, treatment 82 of 355 (23.1%), control 106 of 365 (29.0%), NNT 17, high antigen patients, Cox proportional hazards.

risk of no hospital discharge, 4.2% higher, RR 1.04, p = 0.51, treatment 828, control 895, adjusted per study, inverted to make RR<1 favor treatment, all patients.

risk of death/ICU, 2.0% lower, RR 0.98, p = 0.82, treatment 184 of 799 (23.0%), control 201 of 863 (23.3%), NNT 382, adjusted per study, all patients.

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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. 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.

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. Zhou et al., SARS-CoV-2 Omicron BA.2 Variant Evades Neutralization by Therapeutic Monoclonal Antibodies, bioRxiv, doi:10.1101/2022.02.15.480166.biorxiv.org, 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.

Horby et al., 27 Jan 2025, Randomized Controlled Trial, United Kingdom, peer-reviewed, 32 authors, study period 4 January, 2022 - 19 March, 2024.

This Paper Sotrovimab All

Late treatment
is less effective

Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.

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