I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations. Issue 6 (6th June 2022)

• Record Type: Journal Article
• Authors: Files, Daniel Clark; Matthay, Michael A; Calfee, Carolyn S; Aggarwal, Neil R; Asare, Adam L; Beitler, Jeremy R; Berger, Paul A; Burnham, Ellen L; Cimino, George; Coleman, Melissa H; Crippa, Alessio; Discacciati, Andrea; Gandotra, Sheetal; Gibbs, Kevin W; Henderson, Paul T; Ittner, Caroline A G; Jauregui, Alejandra; Khan, Kashif T; Koff, Jonathan L; Lang, Julie; LaRose, Mary; Levitt, Joe; Lu, Ruixiao; McKeehan, Jeffrey D; Meyer, Nuala J; Russell, Derek W; Thomas, Karl W; Eklund, Martin; Esserman, Laura J; Liu, Kathleen D
• Other Names: author non-byline.; Esserman Laura J author non-byline.; Calfee Carolyn S author non-byline.; Liu Kathleen D author non-byline.; Coleman Melissa H author non-byline.; Matthay Michael A author non-byline.; Beitler Jeremy R author non-byline.; Mittel Aaron M author non-byline.; Asare Adam L author non-byline.; Yen Albert F author non-byline.; Jauregui Alejandra author non-byline.; Crippa Alessio author non-byline.; Suarez Alexis E author non-byline.; Serra Alexis L author non-byline.; Amin Alpesh N author non-byline.; Rosen Amanda author non-byline.; Dzierba Amy L author non-byline.; Discacciati Andrea author non-byline.; Haczku Angela author non-byline.; Barker Anna D author non-byline.; Weisman Ariel R author non-byline.; Daniel Brian M author non-byline.; Morrissey Brian M author non-byline.; Ittner Caroline AG author non-byline.; Jones Chayse author non-byline.; Creel-Bulos Christina author non-byline.; Angelucci Christina M author non-byline.; Files Daniel C author non-byline.; Russell Derek W author non-byline.; Ng Diana author non-byline.; Burnham Ellen L author non-byline.; Youssef Fady A author non-byline.; Chaparro-Rojas Fredy author non-byline.; Harris Gavin H author non-byline.; Barot Harsh V author non-byline.; Su Heny author non-byline.; Garcia Ivan author non-byline.; Sutter Jacqueline B author non-byline.; Dodin Jamal author non-byline.; McKeehan Jeffrey D author non-byline.; Lee Jerry S author non-byline.; Kazianis John author non-byline.; Reilly John P author non-byline.; Koff Jonathan L author non-byline.; Detelich Joshua F author non-byline.; Lang Julie E author non-byline.; Muir Justin author non-byline.; Thomas Karl W author non-byline.; Khan Kashif T author non-byline.; Gosek Katarzyna author non-byline.; Nugent Katherine L author non-byline.; Gibbs Kevin W author non-byline.; Yee Kimberly author non-byline.; Rodrigues Laura G author non-byline.; Macias Laura R author non-byline.; Orr Lindsey A author non-byline.; Boerger Lindsie L author non-byline.; Rosario-Remigio Lissette author non-byline.; Kufa Lucia author non-byline.; Huerta Luis E author non-byline.; Tanios Maged author non-byline.; Reyes Maria B author non-byline.; Eklund Martin author non-byline.; LaRose Mary author non-byline.; Adelman Max W author non-byline.; Juarez Maya M author non-byline.; Jung Michelle author non-byline.; Meyers Michelle author non-byline.; Sternlieb Mitchell P author non-byline.; Cobb Nathan K author non-byline.; Aggarwal Neil author non-byline.; Mangalmurti Nilam S author non-byline.; Meyer Nuala J author non-byline.; Jones Patrice author non-byline.; Berger Paul A author non-byline.; Henderson Paul author non-byline.; Saban Paul L author non-byline.; Marshall Peter S author non-byline.; Robinson Philiip A author non-byline.; Yang Philip author non-byline.; Madahar Purnema author non-byline.; Nair Rahul author non-byline.; Sonti Rajiv author non-byline.; Lee Richard Anthony author non-byline.; Wunderink Richard G author non-byline.; Wahab Romina author non-byline.; Lupu Roxana A author non-byline.; Lu Ruixiao author non-byline.; Kumar Santhi I author non-byline.; Auld Sara C author non-byline.; Fields Scott author non-byline.; Wong Se Fum author non-byline.; Gandotra Sheetal author non-byline.; Pearson Skyler J author non-byline.; Whealon Spencer author non-byline.; Albertson Timothy E author non-byline.; Obermiller Timothy F author non-byline.; Oliver Tony author non-byline.; Darmanian Anita author non-byline.; Schicchi John author non-byline.; Martinez Esmeralda author non-byline.; Sarafian Farjad author non-byline.; Nguyen Julie author non-byline.; Weiler-Lisowski Bethany author non-byline.; Wyatt Jaime author non-byline.; Blevins Daniel author non-byline.; Melendrez Marylee author non-byline.; Lopez Brenda author non-byline.; Tzehaie Hiwet author non-byline.; Amosu Omowunmi author non-byline.; Simonson Austin author non-byline.; Patel Chirag author non-byline.; Levitt Joe author non-byline.; Hardy Erin author non-byline.; Lindgren Brett author non-byline.; Peterfreund Gregory author non-byline.; Landreth Leigha author non-byline.; Parks Lisa author non-byline.; Aggarwal Neil author non-byline.;
• Is Part Of: BMJ open. Volume 12:Issue 6(2022)
• Publication Date: 2022-06-06
• Subjects: COVID-19 -- clinical trials -- adult intensive & critical care; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2021-060664
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: The COVID-19 pandemic brought an urgent need to discover novel effective therapeutics for patients hospitalised with severe COVID-19. The Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis (ISPY COVID-19 trial) was designed and implemented in early 2020 to evaluate investigational agents rapidly and simultaneously on a phase 2 adaptive platform. This manuscript outlines the design, rationale, implementation and challenges of the ISPY COVID-19 trial during the first phase of trial activity from April 2020 until December 2021. Methods and analysis: The ISPY COVID-19 Trial is a multicentre open-label phase 2 platform trial in the USA designed to evaluate therapeutics that may have a large effect on improving outcomes from severe COVID-19. The ISPY COVID-19 Trial network includes academic and community hospitals with significant geographical diversity across the country. Enrolled patients are randomised to receive one of up to four investigational agents or a control and are evaluated for a family of two primary outcomes—time to recovery and mortality. The statistical design uses a Bayesian model with 'stopping' and 'graduation' criteria designed to efficiently discard ineffective therapies and graduate promising agents for definitive efficacy trials. Each investigational agent arm enrols to a maximum of 125 patients per arm and is compared with concurrent controls. As of December 2021, 11 investigational agent arms had been activated, and 8 arms were complete. Enrolment and adaptation of the trial design are ongoing. Ethics and dissemination: ISPY COVID-19 operates under a central institutional review board via Wake Forest School of Medicine IRB00066805. Data generated from this trial will be reported in peer-reviewed medical journals. Trial registration number: NCT04488081 .