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Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab.
Gupta, Anil; Gonzalez-Rojas, Yaneicy; Juarez, Erick; Crespo Casal, Manuel; Moya, Jaynier; Falci, Diego R; Sarkis, Elias; Solis, Joel; Zheng, Hanzhe; Scott, Nicola; Cathcart, Andrea L; Hebner, Christy M; Sager, Jennifer; Mogalian, Erik; Tipple, Craig; Peppercorn, Amanda; Alexander, Elizabeth; Pang, Phillip S; Free, Almena; Brinson, Cynthia; Aldinger, Melissa; Shapiro, Adrienne E.
Afiliación
  • Gupta A; 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 Hospit
  • Gonzalez-Rojas Y; 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 Hospit
  • Juarez E; 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 Hospit
  • Crespo Casal M; 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 Hospit
  • Moya J; 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 Hospit
  • Falci DR; 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 Hospit
  • Sarkis E; 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 Hospit
  • Solis J; 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 Hospit
  • Zheng H; 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 Hospit
  • Scott N; 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 Hospit
  • Cathcart AL; 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 Hospit
  • Hebner CM; 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 Hospit
  • Sager J; 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 Hospit
  • Mogalian E; 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 Hospit
  • Tipple C; 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 Hospit
  • Peppercorn A; 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 Hospit
  • Alexander E; 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 Hospit
  • Pang PS; 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 Hospit
  • Free A; 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 Hospit
  • Brinson C; 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 Hospit
  • Aldinger M; 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 Hospit
  • Shapiro AE; 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 Hospit
N Engl J Med ; 385(21): 1941-1950, 2021 11 18.
Article en En | MEDLINE | ID: mdl-34706189
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 ClinicalTrials.gov number, NCT04545060.).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Progresión de la Enfermedad / Anticuerpos Neutralizantes / Anticuerpos Monoclonales Humanizados / SARS-CoV-2 / Tratamiento Farmacológico de COVID-19 Tipo de estudio: Clinical_trials / Etiology_studies / Incidence_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Progresión de la Enfermedad / Anticuerpos Neutralizantes / Anticuerpos Monoclonales Humanizados / SARS-CoV-2 / Tratamiento Farmacológico de COVID-19 Tipo de estudio: Clinical_trials / Etiology_studies / Incidence_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos