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PRESCO: Predictors of Severe COVID-19 Outcomes

Sponsor
Verily Life Sciences LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04388813
Collaborator
(none)
494
Enrollment
8
Locations
16.1
Anticipated Duration (Months)
61.8
Patients Per Site
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    494 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Predictors of Severe COVID-19 Outcomes (PRESCO)
    Actual Study Start Date :
    May 28, 2020
    Anticipated Primary Completion Date :
    Oct 1, 2021
    Anticipated Study Completion Date :
    Oct 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Performance (discrimination / calibration) of models [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Arizona Tucson Arizona United States 85719
    2 Cedars-Sinai Medical Center Los Angeles California United States 90048
    3 University of Illinois at Chicago Chicago Illinois United States 60607
    4 Rush University Medical Center Chicago Illinois United States 60612
    5 Weill Cornell Medical College New York New York United States 10065
    6 University of Texas Southwestern Medical Center Dallas Texas United States 75390
    7 Baylor College of Medicine Houston Texas United States 77030
    8 Inova Health Care Services Falls Church Virginia United States 22042

    Sponsors and Collaborators

    • Verily Life Sciences LLC

    Investigators

    • Study Director: Charlie Kim, PhD, Verily Life Sciences
    • Study Director: William Marks, MD, Verily Life Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Verily Life Sciences LLC
    ClinicalTrials.gov Identifier:
    NCT04388813
    Other Study ID Numbers:
    • 102293
    First Posted:
    May 14, 2020
    Last Update Posted:
    Aug 17, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Acute Lung Injury

    Study Results

    No Results Posted as of Aug 17, 2021