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Trial record 1 of 1 for:    NCT04388813
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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. Read our disclaimer for details. Identifier: NCT04388813
Recruitment Status : Active, not recruiting
First Posted : May 14, 2020
Last Update Posted : August 17, 2021
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
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
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT04388813

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United States, Arizona
The University of Arizona
Tucson, Arizona, United States, 85719
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60607
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Inova Health Care Services
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Verily Life Sciences LLC
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Study Director: Charlie Kim, PhD Verily Life Sciences
Study Director: William Marks, MD Verily Life Sciences
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Responsible Party: Verily Life Sciences LLC Identifier: NCT04388813    
Other Study ID Numbers: 102293
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021

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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
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury