Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19

作者：Christoph D. Spinner, Robert Gottlieb, Gerard J. Criner, José Ramón Arribas, Anna Maria Cattelan, Àlex Soriano, Onyema Ogbuagu, Prashant Malhotra, Kathleen M. Mullane, Antonella Castagna, Louis Yi Ann Chai, Meta Roestenberg, Owen Tak Yin Tsang, Enos Bernasconi, Paul Le Turnier, Shan‐Chwen Chang, Devi SenGupta, Robert H. Hyland, Anu Osinusi, Huyen Cao, Christiana Blair, Hongyuan Wang, Anuj Gaggar, Diana M. Brainard, Mark McPhail, Sanjay Bhagani, Mi Young Ahn, Arun J. Sanyal, Gregory Huhn, Francisco M. Marty, for the GS-US-540-5774 Investigators · 发表于：JAMA · 年份：2020 · DOI：10.1001/jama.2020.16349 · 被引用次数：1280 · 研究领域：COVID-19 Clinical Research Studies、SARS-CoV-2 and COVID-19 Research、Pharmacological Receptor Mechanisms and Effects

Importance: Remdesivir demonstrated clinical benefit in a placebo-controlled trial in patients with severe coronavirus disease 2019 (COVID-19), but its effect in patients with moderate disease is unknown. Objective: To determine the efficacy of 5 or 10 days of remdesivir treatment compared with standard care on clinical status on day 11 after initiation of treatment. Design, Setting, and Participants: Randomized, open-label trial of hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation >94%) enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia. The date of final follow-up was May 20, 2020. Interventions: Patients were randomized in a 1:1:1 ratio to receive a 10-day course of remdesivir (n = 197), a 5-day course of remdesivir (n = 199), or standard care (n = 200). Remdesivir was dosed intravenously at 200 mg on day 1 followed by 100 mg/d. Main Outcomes and Measures: The primary end point was clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7). Differences between remdesivir treatment groups and standard care were calculated using proportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicates difference in clinical status distribution toward category 7 for the remdesivir group vs the standard care grou...