Predictors of Severe COVID-19 Outcomes

Completed

• Conditions: Acute Respiratory Distress Syndrome; COVID-19

• Registration Number: NCT04388813
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-14
• Study Start: 2020-05-28
• Primary Completion: 2021-09-23
• Study Completion: 2021-09-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

The University of Arizona; 🇺🇸 Tucson, Arizona, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Inova Health Care Services; 🇺🇸 Falls Church, Virginia, United States