e-Article
The UPMC OPTIMISE-C19 (OPtimizing Treatment and Impact of Monoclonal antIbodieS through Evaluation for COVID-19) trial: a structured summary of a study protocol for an open-label, pragmatic, comparative effectiveness platform trial with response-adaptive randomization
Document Type
article
Author
David T. Huang; Erin K. McCreary; J. Ryan Bariola; Richard J. Wadas; Kevin E. Kip; Oscar C. Marroquin; Stephen Koscumb; Kevin Collins; Judith A. Shovel; Mark Schmidhofer; Mary Kay Wisniewski; Colleen Sullivan; Donald M. Yealy; Meredith Axe; David A. Nace; Ghady Haidar; Tina Khadem; Kelsey Linstrum; Graham M. Snyder; Christopher W. Seymour; Stephanie K. Montgomery; Bryan J. McVerry; Lindsay Berry; Scott Berry; Russell Meyers; Alexandra Weissman; Octavia M. Peck-Palmer; Alan Wells; Robert Bart; Debbie L. Albin; Tami Minnier; Derek C. Angus
Source
Trials, Vol 22, Iss 1, Pp 1-3 (2021)
Subject
Language
English
ISSN
1745-6215
Abstract
Abstract Objectives The primary objective is to evaluate the comparative effectiveness of COVID-19 specific monoclonal antibodies (mABs) with US Food and Drug Administration (FDA) Emergency Use Authorization (EUA), alongside UPMC Health System efforts to increase patient access to these mABs. Trial design Open-label, pragmatic, comparative effectiveness platform trial with response-adaptive randomization Participants We will evaluate patients who meet the eligibility criteria stipulated by the COVID-19 mAB EUAs who receive mABs within the UPMC Health System, including infusion centers and emergency departments. EUA eligibility criteria include patients with mild to moderate COVID-19,