Predictors of Severe COVID-19 Outcomes

COVID-19 Clinical Trial

— PRESCO  

Official title:

Predictors of Severe COVID-19 Outcomes (PRESCO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388813
• Other study ID #: 102293
• Status: Completed
• Start date: May 28, 2020
• Est. completion date: September 23, 2021

Study information

• Verified date: May 2024
• Source: Verily Life Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: September 23, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Inova Health Care Services	Falls Church	Virginia
United States	Baylor College of Medicine	Houston	Texas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Weill Cornell Medical College	New York	New York
United States	The University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Verily Life Sciences LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance (discrimination / calibration) of models	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.	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).