1. Report of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trialResearch in context
- Author
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D. Clark Files, Neil Aggarwal, Timothy Albertson, Sara Auld, Jeremy R. Beitler, Paul Berger, Ellen L. Burnham, Carolyn S. Calfee, Nathan Cobb, Alessio Crippa, Andrea Discacciati, Martin Eklund, Laura Esserman, Eliot Friedman, Sheetal Gandotra, Kashif Khan, Jonathan Koff, Santhi Kumar, Kathleen D. Liu, Thomas R. Martin, Michael A. Matthay, Nuala J. Meyer, Timothy Obermiller, Philip Robinson, Derek Russell, Karl Thomas, Se Fum Wong, Richard G. Wunderink, Mark M. Wurfel, Albert Yen, Fady A. Youssef, Anita Darmanian, Amy L. Dzierba, Ivan Garcia, Katarzyna Gosek, Purnema Madahar, Aaron M. Mittel, Justin Muir, Amanda Rosen, John Schicchi, Alexis L. Serra, Romina Wahab, Kevin W. Gibbs, Leigha Landreth, Mary LaRose, Lisa Parks, Adina Wynn, Caroline A.G. Ittner, Nilman S. Mangalmurti, John P. Reilly, Donna Harris, Abhishek Methukupally, Siddharth Patel, Lindsie Boerger, John Kazianis, Carrie Higgins, Jeff McKeehan, Brian Daniel, Scott Fields, James Hurst-Hopf, Alejandra Jauregui, Lamorna Brown Swigart, Daniel Blevins, Catherine Nguyen, Alexis Suarez, Maged A. Tanios, Farjad Sarafian, Usman Shah, Max Adelman, Christina Creel-Bulos, Joshua Detelich, Gavin Harris, Katherine Nugent, Christina Spainhour, Philip Yang, Angela Haczku, Erin Hardy, Richart Harper, Brian Morrissey, Christian Sandrock, G. R. Scott Budinger, Helen K. Donnelly, Benjamin D. Singer, Ari Moskowitz, Melissa Coleman, Joseph Levitt, Ruixiao Lu, Paul Henderson, Adam Asare, Imogene Dunn, and Alejandro Botello Barragan
- Subjects
SARS-CoV-2 ,Respiratory insufficiency ,Clinical trial ,Acute lung injury ,Medicine (General) ,R5-920 - Abstract
Summary: Background: An urgent need exists to rapidly screen potential therapeutics for severe COVID-19 or other emerging pathogens associated with high morbidity and mortality. Methods: Using an adaptive platform design created to rapidly evaluate investigational agents, hospitalised patients with severe COVID-19 requiring ≥6 L/min oxygen were randomised to either a backbone regimen of dexamethasone and remdesivir alone (controls) or backbone plus one open-label investigational agent. Patients were enrolled to the arms described between July 30, 2020 and June 11, 2021 in 20 medical centres in the United States. The platform contained up to four potentially available investigational agents and controls available for randomisation during a single time-period. The two primary endpoints were time-to-recovery (
- Published
- 2023
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