Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
| العنوان: | Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab |
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| المؤلفون: | Anil, Gupta, Yaneicy, Gonzalez-Rojas, Erick, Juarez, Manuel, Crespo Casal, Jaynier, Moya, Diego R, Falci, Elias, Sarkis, Joel, Solis, Hanzhe, Zheng, Nicola, Scott, Andrea L, Cathcart, Christy M, Hebner, Jennifer, Sager, Erik, Mogalian, Craig, Tipple, Amanda, Peppercorn, Elizabeth, Alexander, Phillip S, Pang, Almena, Free, Cynthia, Brinson, Melissa, Aldinger, Adrienne E, Shapiro, Luis, Zepeda |
| المصدر: | The New England journal of medicine. 385(21) |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Adult, Male, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Antibodies, Monoclonal, Humanized, Older patients, Double-Blind Method, Ambulatory Care, Medicine, Humans, Neutralizing antibody, Infusions, Intravenous, Aged, biology, business.industry, SARS-CoV-2, Incidence, General Medicine, Length of Stay, Middle Aged, Virology, Antibodies, Neutralizing, Intention to Treat Analysis, COVID-19 Drug Treatment, Hospitalization, biology.protein, Disease Progression, Female, business |
| الوصف: | 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.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 (for24 hours) for any cause or death within 29 days after randomization.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).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.). |
| تدمد: | 1533-4406 0454-5060 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3b5f445ae6fb12ebf06154da972781a2 https://pubmed.ncbi.nlm.nih.gov/35294998 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....3b5f445ae6fb12ebf06154da972781a2 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15334406 04545060 |
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