Report of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trial
Consortium T, Files D, Aggarwal N, Albertson T, Auld S, Beitler J, Berger P, Burnham E, Calfee C, Cobb N, Crippa A, Discacciati A, Eklund M, Esserman L, Friedman E, Gandotra S, Khan K, Koff J, Kumar S, Liu K, Martin T, Matthay M, Meyer N, Obermiller T, Robinson P, Russell D, Thomas K, Wong F, Wunderink R, Wurfel M, Yen A, Youssef F, Darmanian A, Dzierba A, Garcia I, Gosek K, Madahar P, Mittel A, Muir J, Rosen A, Schicchi J, Serra A, Wahab R, Gibbs K, Landreth L, LaRose M, Parks L, Wynn A, Ittner C, Mangalmurti N, Reilly J, Harris D, Methukupally A, Patel S, Boerger L, Kazianis J, Higgins C, McKeehan J, Daniel B, Fields S, Hurst-Hopf J, Jauregui A, Swigart L, Blevins D, Nguyen C, Suarez A, Tanios M, Sarafian F, Shah U, Adelman M, Creel-Bulos C, Detelich J, Harris G, Nugent K, Spainhour C, Yang P, Haczku A, Hardy E, Harper R, Morrissey B, Sandrock C, Budinger G, Donnelly H, Singer B, Moskowitz A, Coleman M, Levitt J, Lu R, Henderson P, Asare A, Dunn I, Barragan A. Report of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trial. EClinicalMedicine 2023, 58: 101889. PMID: 36883141, PMCID: PMC9981330, DOI: 10.1016/j.eclinm.2023.101889.Peer-Reviewed Original ResearchInvestigational agentsSevere COVID-19Hazard ratioModified intention-to-treat analysisEvaluating investigational agentsRegimen of dexamethasoneIntention-to-treat analysisBackbone regimensOpen-labelDornase alfaEfficacy signalsScreening of agentsScreening potential therapeuticsData monitoring committeeHigh morbidityAdaptive platform trialCOVID trialsMedical CentrePfizer Inc.Controlled trialsHospitalised patientsI-SPYPre-specified criteriaFast GrantTime-to-recovery
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