I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations
Abstract
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.
Document Details
- Document Type
- Pub Defense Publication
- Publication Date
- Jun 01, 2022
- Source ID
- 10.1136/bmjopen-2021-060664
Entities
People
- Adam L Asare
- Alejandra Jauregui
- Alessio Crippa
- Andrea Discacciati
- Caroline A. G. Ittner
- Carolyn Calfee
- Daniel Clark Files
- Derek W. Russell
- Ellen L. Burnham
- George Cimino
- Jeffrey D Mckeehan
- Jeremy R Beitler
- Joe Levitt
- Jonathan L Koff
- Julie Lang
- Karl W Thomas
- Kashif T Khan
- Kathleen D Liu
- Kevin W Gibbs
- Laura J. Esserman
- Martin Eklund
- Mary Larose
- Melissa H Coleman
- Michael A. Matthay
- Neil R Aggarwal
- Nuala J Meyer
- Paul A Berger
- Paul T. Henderson
- Ruixiao Lu
- Sheetal Gandotra
Organizations
- United States Department of Defense