Conv. Plasma
Nigella Sativa
Nitric Oxide
Peg.. Lambda

Home   COVID-19 treatment studies for Sotrovimab  COVID-19 treatment studies for Sotrovimab  C19 studies: Sotrovimab  Sotrovimab   Select treatmentSelect treatmentTreatmentsTreatments
Alkalinization Meta Lactoferrin Meta
Melatonin Meta
Bromhexine Meta Metformin Meta
Budesonide Meta Molnupiravir Meta
Cannabidiol Meta
Colchicine Meta Nigella Sativa Meta
Conv. Plasma Meta Nitazoxanide Meta
Curcumin Meta Nitric Oxide Meta
Ensovibep Meta Paxlovid Meta
Famotidine Meta Peg.. Lambda Meta
Favipiravir Meta Povidone-Iod.. Meta
Fluvoxamine Meta Quercetin Meta
Hydroxychlor.. Meta Remdesivir Meta
Iota-carragee.. Meta
Ivermectin Meta Zinc Meta

Other Treatments Global Adoption
All Studies   Meta Analysis   Recent:  
0 0.5 1 1.5 2+ Mortality 67% Improvement Relative Risk Ventilation 80% ICU admission 91% Hospitalization 81% Hospitalization (b) 86% primary Gupta et al. NCT04545060 Sotrovimab RCT EARLY TREATMENT Is early treatment with sotrovimab beneficial for COVID-19? Double-blind RCT 583 patients in the USA Lower hospitalization with sotrovimab (p=0.00071) Gupta et al., NEJM, doi:10.1056/NEJMoa2107934 Favors sotrovimab Favors control
Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
Gupta et al., NEJM, doi:10.1056/NEJMoa2107934 (news release 5/26/2021) (Preprint), NCT04545060 (history)
Gupta et al., Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab, NEJM, doi:10.1056/NEJMoa2107934 (news release 5/26/2021) (Preprint), NCT04545060
May 2021   Source   PDF  
  All Studies   Meta
Interim results from the COMET-ICE trial showing significantly lower hospitalization with treatment. NCT04545060 (history).
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 [Liu, Sheward, VanBlargan] and a lack of efficacy for BA.2 [Zhou]. US EUA has been revoked.
risk of death, 66.6% lower, RR 0.33, p = 1.00, treatment 0 of 291 (0.0%), control 1 of 292 (0.3%), NNT 292, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of mechanical ventilation, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 291 (0.0%), control 2 of 292 (0.7%), NNT 146, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of ICU admission, 90.9% lower, RR 0.09, p = 0.06, treatment 0 of 291 (0.0%), control 5 of 292 (1.7%), NNT 58, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of hospitalization, 80.9% lower, RR 0.19, p < 0.001, treatment 4 of 291 (1.4%), control 21 of 292 (7.2%), NNT 17.
risk of hospitalization, 85.7% lower, RR 0.14, p < 0.001, treatment 3 of 291 (1.0%), control 21 of 292 (7.2%), NNT 16, >24hrs, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Gupta et al., 26 May 2021, Double Blind Randomized Controlled Trial, USA, preprint, 22 authors, trial NCT04545060 (history).
All Studies   Meta Analysis   Submit Updates or Corrections
This PaperSotrovimabAll
Abstract: The n e w e ng l a n d j o u r na l of m e dic i n e Original Article Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab Anil Gupta, M.D., Yaneicy Gonzalez‑Rojas, M.D., Erick Juarez, M.D., Manuel Crespo Casal, M.D., Jaynier Moya, M.D., Diego R. Falci, M.D., Ph.D., Elias Sarkis, M.D., Joel Solis, M.D., Hanzhe Zheng, Ph.D., Nicola Scott, M.Sc., Andrea L. Cathcart, Ph.D., Christy M. Hebner, Ph.D., Jennifer Sager, Ph.D., Erik Mogalian, Pharm.D., Ph.D., Craig Tipple, M.B., B.S., Ph.D., Amanda Peppercorn, M.D., Elizabeth Alexander, M.D., Phillip S. Pang, M.D., Ph.D., Almena Free, M.D., Cynthia Brinson, M.D., Melissa Aldinger, Pharm.D., and Adrienne E. Shapiro, M.D., Ph.D., for the COMET-ICE Investigators*​​ A BS T R AC T BACKGROUND Coronavirus disease 2019 (Covid-19) disproportionately results in hospitalization or death in older patients and those with underlying conditions. Sotrovimab is a pan-sarbecovirus monoclonal antibody that was designed to prevent progression of Covid-19 in high-risk patients early in the course of disease. METHODS In this ongoing, multicenter, double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, nonhospitalized patients with symptomatic Covid-19 (≤5 days after the onset of symptoms) and at least one risk factor for disease progression to receive a single infusion of sotrovimab at a dose of 500 mg or placebo. The primary efficacy outcome was hospitalization (for >24 hours) for any cause or death within 29 days after randomization. RESULTS In this prespecified interim analysis, which included an intention-to-treat population of 583 patients (291 in the sotrovimab group and 292 in the placebo group), 3 patients (1%) in the sotrovimab group, as compared with 21 patients (7%) in the placebo group, had disease progression leading to hospitalization or death (relative risk reduction, 85%; 97.24% confidence interval, 44 to 96; P = 0.002). In the placebo group, 5 patients were admitted to the intensive care unit, including 1 who died by day 29. Safety was assessed in 868 patients (430 in the sotrovimab group and 438 in the placebo group). Adverse events were reported by 17% of the patients in the sotrovimab group and 19% of those in the placebo group; serious adverse events were less common with sotrovimab than with placebo (in 2% and 6% of the patients, respectively). CONCLUSIONS Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression. No safety signals were identified. (Funded by Vir Biotechnology and GlaxoSmithKline; COMET-ICE number, NCT04545060.) From the Albion Finch Medical Centre, William Osler Health Centre, Toronto (A.G.); Optimus U (Y.G.-R.) and Florida International Medical Research (E.J.), Miami, Pines Care Research Center, Pembroke Pines (J.M.), and Sarkis Clinical Trials, Gainesville (E.S.) — all in Florida; Álvaro Cunqueiro Hospital, IIS Galicia Sur, Vigo, Spain (M.C.C.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (D.R.F.); Centex Studies, McAllen (J. Solis), and Central Texas Clinical Research, Austin (C.B.) — both in Texas; Vir Biotechnology, San Francisco (H.Z., A.L.C., C.M.H., J. Sager, E.M., E.A., P.S.P., M.A.); GlaxoSmithKline, Stevenage, United Kingdom (N.S., C.T.); GlaxoSmithKline, Cambridge, MA (A.P.); Pinnacle Research Group, Anniston, AL (A.F.); and the Departments of Global Health and Medicine, University of Washington, and Fred Hutchinson Cancer Research..
Please send us corrections, updates, or comments. Vaccines and treatments are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment, vaccine, 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.
  or use drag and drop