I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations.

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 outc

SUBMITTER: Files DC 

PROVIDER: S-EPMC9170797 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature