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Clinical Trials/NCT04388813
NCT04388813
Completed
Not Applicable

Predictors of Severe COVID-19 Outcomes (PRESCO)

Verily Life Sciences LLC8 sites in 1 country494 target enrollmentMay 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Verily Life Sciences LLC
Enrollment
494
Locations
8
Primary Endpoint
Performance (discrimination / calibration) of models
Status
Completed
Last Updated
last year

Overview

Brief Summary

This 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 duration of the study participation is approximately 3 months.

Registry
clinicaltrials.gov
Start Date
May 28, 2020
End Date
September 23, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Participant or legally authorized representative willing and able to provide informed consent
  • Receiving care at a participating site
  • Age 18 years old or older
  • U.S. Resident
  • Confirmed positive for COVID-19
  • Willing and able to comply with all study procedures

Exclusion Criteria

  • Self reported pregnancy

Outcomes

Primary Outcomes

Performance (discrimination / calibration) of models

Time Frame: From date of study enrollment until the date of first documented ARDS diagnosis or date of death from any cause, whichever comes first, assessed up to study end (estimated at 3 months).

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.

Study Sites (8)

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