Ontology highlight
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.
SUBMITTER: Files DC
PROVIDER: S-EPMC9170797 | biostudies-literature | 2022 Jun
REPOSITORIES: biostudies-literature
Files Daniel Clark DC Matthay Michael A MA Calfee Carolyn S CS Aggarwal Neil R NR Asare Adam L AL Beitler Jeremy R JR Berger Paul A PA Burnham Ellen L EL Cimino George G Coleman Melissa H MH Crippa Alessio A Discacciati Andrea A Gandotra Sheetal S Gibbs Kevin W KW Henderson Paul T PT Ittner Caroline A G CAG Jauregui Alejandra A Khan Kashif T KT Koff Jonathan L JL Lang Julie J LaRose Mary M Levitt Joe J Lu Ruixiao R McKeehan Jeffrey D JD Meyer Nuala J NJ Russell Derek W DW Thomas Karl W KW Eklund Martin M Esserman Laura J LJ Liu Kathleen D KD
BMJ open 20220606 6
<h4>Introduction</h4>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 ...[more]