학술논문
Evaluating Primary Endpoints for COVID-19 Therapeutic Trials to Assess Recovery.
Document Type
article
Author
Douin, David J; Siegel, Lianne; Grandits, Greg; Phillips, Andrew; Aggarwal, Neil R; Baker, Jason; Brown, Samuel M; Chang, Christina C; Goodman, Anna L; Grund, Birgit; Higgs, Elizabeth S; Hough, Catherine L; Murray, Daniel D; Paredes, Roger; Parmar, Mahesh; Pett, Sarah; Polizzotto, Mark N; Sandkovsky, Uriel; Self, Wesley H; Young, Barnaby E; Babiker, Abdel G; Davey, Victoria J; Kan, Virginia; Gelijns, Annetine C; Matthews, Gail; Thompson, B Taylor; Lane, H Clifford; Neaton, James D; Lundgren, Jens D; Ginde, Adit A
Source
American journal of respiratory and critical care medicine. 206(6)
Subject
Language
Abstract
Rationale: Uncertainty regarding the natural history of coronavirus disease (COVID-19) led to difficulty in efficacy endpoint selection for therapeutic trials. Capturing outcomes that occur after hospital discharge may improve assessment of clinical recovery among hospitalized patients with COVID-19. Objectives: Evaluate 90-day clinical course of patients hospitalized with COVID-19, comparing three distinct definitions of recovery. Methods: We used pooled data from three clinical trials of neutralizing monoclonal antibodies to compare: 1) the hospital discharge approach; 2) the TICO (Therapeutics for Inpatients with COVID-19) trials sustained recovery approach; and 3) a comprehensive approach. At the time of enrollment, all patients were hospitalized in a non-ICU setting without organ failure or major extrapulmonary manifestations of COVID-19. We defined discordance as a difference between time to recovery. Measurements and Main Results: Discordance between the hospital discharge and comprehensive approaches occurred in 170 (20%) of 850 enrolled participants, including 126 hospital readmissions and 24 deaths after initial hospital discharge. Discordant participants were older (median age, 68 vs. 59 years; P