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Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days

Authors :
Erin K. McCreary
J. Ryan Bariola
Tami Minnier
Richard J. Wadas
Judith A. Shovel
Debbie Albin
Oscar C. Marroquin
Mark Schmidhofer
Mary Kay Wisniewski
David A. Nace
Colleen Sullivan
Meredith Axe
Russell Meyers
Tina Khadem
William Garrard
Kevin Collins
Alan Wells
Robert D. Bart
Kelsey Linstrum
Stephanie K. Montgomery
Ghady Haidar
Graham M. Snyder
Bryan J. McVerry
Christopher W. Seymour
Donald M. Yealy
David T. Huang
Derek C. Angus
Source :
Contemporary Clinical Trials
Publication Year :
2021
Publisher :
The Authors. Published by Elsevier Inc., 2021.

Abstract

Outpatient treatments that limit progression to severe coronavirus disease 2019 (COVID-19) are of vital importance to optimise patient outcomes and public health. Monoclonal antibodies (mAb) demonstrated ability to decrease hospitalizations in randomized, clinical trials. However, there are many barriers to mAb treatment such as patient access and clinician education. There are no data comparing efficacy or safety of available mAbs. We sought to rapidly launch an adaptive platform trial with the goals of enhancing access to treatment, regardless of geography and socioeconomic status, and evaluating comparative efficacy and safety of available mAbs. Within 21 days from idea genesis, we allocated mAb treatment to all patients within the context of this clinical trial. Within 2 months, we closed the gap of the likelihood of receiving mAb, conditional on background positivity rate, between Black and White patients (Black patients 0.238; White patients 0.241). We describe trial infrastructure, lessons learned, and future directions for a culture of learning while doing.

Details

Language :
English
ISSN :
15592030 and 15517144
Volume :
113
Database :
OpenAIRE
Journal :
Contemporary Clinical Trials
Accession number :
edsair.doi.dedup.....e73a31577d98adf547ad249060bbc7e7