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Evaluating Primary Endpoints for COVID-19 Therapeutic Trials to Assess Recovery

Am J Respir Crit Care Med. 2022-09; 
David J Douin, Lianne Siegel, Greg Grandits, Andrew Phillips, Neil R Aggarwal, Jason Baker, Samuel M Brown, Christina C Chang, Anna L Goodman, Birgit Grund, Elizabeth S Higgs, Catherine L Hough, Daniel D Murray, Roger Paredes, Mahesh Parmar, Sarah Pett, Mark N Polizzotto, Uriel Sandkovsky, Wesley H Self, Barnaby E Young, Abdel G Babiker, Victoria J Davey, Virginia Kan, Annetine C Gelijns, Gail Matthews, B Taylor Thompson, H Clifford Lane, James D Neaton, Jens D Lundgren, Adit A Ginde
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Catalog Antibody … ‡ SARS-CoV-2 antibodies refer to GenScript antibody interpretation and SARS-CoV-2 … Healthcare utilization and costs in ARDS survivors: a 1-year longitudinal national US multicenter … Get A Quote

摘要

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. Evaluate 90-day clinical course of patients hospitalized with COVID-19, comparing three distinct definitions of recovery. We used pooled data from three clinical trials of neutralizing monoclonal antibodies to compare: ) the hospital discharge approach; ) the TICO (Therapeutics for Inpatients with COVID-19) trials sustained recovery approach; and ) a comprehensive approach. At the time of enrollment, all patients were hospi... More

关键词

COVID-19, monoclonal antibodies, outcomes assessment
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