NCT04388813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
494

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

May 28, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2021

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

May 4, 2020

Last Update Submit

May 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants confirmed positive for COVID-19.

You may qualify if:

  • 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

You may not qualify if:

  • Self reported pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

The University of Arizona

Tucson, Arizona, 85719, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Inova Health Care Services

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Respiratory Distress SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Study Officials

  • Charlie Kim, PhD

    Verily Life Sciences LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 14, 2020

Study Start

May 28, 2020

Primary Completion

September 23, 2021

Study Completion

September 23, 2021

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations