Predictors of SEVERE COVID-19 Outcomes (PRESCO)

PRESCO stands for “Predictors of Severe COVID-19 Outcomes”.  PRESCO is a longitudinal, multi-center, observational study collecting diverse biological measurements and clinical and epidemiological data for the purpose of enabling a greater understanding of the onset of severe outcomes, primarily acute respiratory distress syndrome (ARDS) and/or mortality, in patients presenting to the hospital with suspicion or diagnosis of COVID-19. We seek to understand whether there are early signatures that predict progression to ARDS, mortality, and/or other comorbid conditions.

The primary objective of the study is to build models that predict the risk of development of ARDS and/or mortality among COVID-19 patients who present to the hospital for evaluation and treatment, to inform prioritization of those individuals at high-risk for earlier and more aggressive intervention. Risk prediction will be based on epidemiological, clinical, cellular, and/or molecular signatures that will be identified in the course of the study.  The primary endpoint of the study is performance (discrimination / calibration) of models that predict the risk of development of ARDS and/or mortality among COVID-19 patients who present to the hospital for evaluation and treatment.

Approximately 1500 participants classified as a Person Under Investigation (PUI) for COVID-19 or confirmed positive for COVID-19 will be enrolled from approximately 10 investigational sites. Investigational sites may include satellite locations of a primary site.  Participants will be enrolled from the time they present to the hospital until discharge (estimated to be approximately 0-21 days). An optional post-discharge follow-up visit will occur approximately 90 days after discharge.

Site PIs:  Dawood Darbar, MD; Patricia Finn, MD; Terry Vanden Hoek, MD; Jeff Jacobson, MD; Jan Kitajewski, PhD; Jerry Krishnan, MD, PhD; Janet Lin, MD, MHA, MBA; Heather Prendergast, MD, MPH, MS;