Rationale and Design of the Awake Prone Position for Early Hypoxemia in COVID-19 Study Protocol A Clinical Trial

Michael A. Garcia, Garrett L. Rampon, Gheorghe Doros, Shijing Jia, Nikhil Jagan, Kari Gillmeyer, Andrew Berical, James Hudspeth, Michael Ieong, Katherine L. Modzelewski, Elissa M. Schechter-Perkins, Craig S. Ross, Justin M. Rucci, Steven Simpson, Allan J. Walkey, Nicholas A. Bosch

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

The unprecedented public health burdens of coronavirus disease (COVID-19) have intensified the urgency of identifying effective, low-cost treatments that limit the need for advanced life support measures and improve clinical outcomes. However, personal protective equipment and staffing shortages, disease virulence, and infectivity have created significant barriers to traditional clinical trial practices. We present the novel design of a pragmatic, adaptive, multicenter, international, prospective randomized controlled clinical trial evaluating the safety and effectiveness of awake prone positioning in spontaneously breathing patients with COVID-19 (APPEX-19 [Awake Prone Position for Early Hypoxemia in COVID-19]). Key innovations of this trial include 1) a novel smartphone-based communication process that facilitates rapid enrollment and intervention delivery while allowing social distancing and conservation of personal protective equipment, 2) Bayesian response-adaptive randomization to allow preferential assignment to the most effective intervention and expedite trial completion compared with frequentist designs, 3) remote electronic collection of patient-reported outcomes and electronic medical record data, and 4) pragmatic prospective use of patient-reported data and data collected as part of routine clinical care.

Original languageEnglish (US)
Pages (from-to)1560-1566
Number of pages7
JournalAnnals of the American Thoracic Society
Volume18
Issue number9
DOIs
StatePublished - Sep 2021

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine

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