2023
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
2022
I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations
Files DC, Matthay MA, Calfee CS, Aggarwal NR, Asare AL, Beitler JR, Berger PA, Burnham EL, Cimino G, Coleman MH, Crippa A, Discacciati A, Gandotra S, Gibbs KW, Henderson PT, Ittner CAG, Jauregui A, Khan KT, Koff JL, Lang J, LaRose M, Levitt J, Lu R, McKeehan JD, Meyer NJ, Russell DW, Thomas KW, Eklund M, Esserman LJ, Liu KD, Esserman L, Calfee C, Liu K, Coleman M, Matthay M, Beitler J, Mittel A, Asare A, Yen A, Jauregui A, Crippa A, Suarez A, Serra A, Amin A, Rosen A, Dzierba A, Discacciati A, Haczku A, Barker A, Weisman A, Daniel B, Morrissey B, Ittner C, Jones C, Creel-Bulos C, Angelucci C, Files D, Russell D, Ng D, Burnham E, Youssef F, Chaparro-Rojas F, Harris G, Barot H, Su H, Garcia I, Sutter J, Dodin J, McKeehan J, Lee J, Kazianis J, Reilly J, Koff J, Detelich J, Lang J, Muir J, Thomas K, Khan K, Gosek K, Nugent K, Gibbs K, Yee K, Rodrigues L, Macias L, Orr L, Boerger L, Rosario-Remigio L, Kufa L, Huerta L, Tanios M, Reyes M, Eklund M, LaRose M, Adelman M, Juarez M, Jung M, Meyers M, Sternlieb M, Cobb N, Aggarwal N, Mangalmurti N, Meyer N, Jones P, Berger P, Henderson P, Saban P, Marshall P, Robinson P, Yang P, Madahar P, Nair R, Sonti R, Lee R, Wunderink R, Wahab R, Lupu R, Lu R, Kumar S, Auld S, Fields S, Wong F, Gandotra S, Pearson S, Whealon S, Albertson T, Obermiller T, Oliver T, Darmanian A, Schicchi J, Martinez E, Sarafian F, Nguyen J, Weiler-Lisowski B, Wyatt J, Blevins D, Melendrez M, Lopez B, Tzehaie H, Amosu O, Simonson A, Patel C, Levitt J, Hardy E, Lindgren B, Peterfreund G, Landreth L, Parks L, Aggarwal N. I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations. BMJ Open 2022, 12: e060664. PMID: 35667714, PMCID: PMC9170797, DOI: 10.1136/bmjopen-2021-060664.Peer-Reviewed Original ResearchConceptsSevere COVID-19COVID-19 trialsInvestigational agentsPlatform trialsCOVID-19 acute respiratory failureDefinitive efficacy trialAcute respiratory failureAdaptive platform trialPeer-reviewed medical journalsCOVID-19Novel effective therapeuticsCentral institutional review boardInstitutional review boardRespiratory failureIneffective therapyTherapeutic responseCommunity hospitalEfficacy trialsSerial studiesTrial designWake Forest SchoolEffective therapeuticsTrials NetworkPromising agentPatients