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Predictors of Severe COVID-19 Outcomes (PRESCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04388813
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Verily Life Sciences LLC

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
Acute Respiratory Distress Syndrome COVID-19

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Severe COVID-19 Outcomes (PRESCO)
Actual Study Start Date : May 28, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants confirmed positive for COVID-19.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388813


Contacts
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Contact: Leera Choi 650-880-5106 leerac@verily.com

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60607
Contact: Lauren Castro    312-413-3291    lschra3@UIC.EDU   
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: James Moy, MD    312-942-6176    jmoy@rush.edu   
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Stephanie Reyes       Stephanie.Reyes@utsouthwestern.edu   
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Ivan Rosas, MD    713-798-8842    ivan.rosas@bcm.edu   
United States, Virginia
Inova Health Care Services Recruiting
Falls Church, Virginia, United States, 22042
Contact: Stephanie Garofalo    703-776-2018    Stephanie.Garofalo@inova.org   
Sponsors and Collaborators
Verily Life Sciences LLC
Investigators
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Study Director: Charlie Kim, PhD Verily Life Sciences
Study Director: Howard Zisser, MD Verily Life Sciences
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Responsible Party: Verily Life Sciences LLC
ClinicalTrials.gov Identifier: NCT04388813    
Other Study ID Numbers: 102293
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury