Predictors of Severe COVID-19 Outcomes | NCT04388813

Studies
Predictors of Severe COVID-19 Outcomes

NCT04388813

Sponsor

Verily Life Sciences LLC

Status

Completed

Last Update Posted

May 28, 2024Actual

Enrollment

494Actual

Phase

Not provided

Conditions

Acute Respiratory Distress Syndrome
COVID-19

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 28, 2020Actual

Primary Completion Date

Sep 23, 2021Actual

Completion Date

Sep 23, 2021Actual

First Submitted Date

May 4, 2020

First Submission Date that Met QC Criteria

May 13, 2020

First Posted Date

May 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2024

Last Update Posted Date

May 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

494Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants confirmed positive for COVID-19.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charlie Kim, PhD	Verily Life Sciences LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Arizona		Tucson	Arizona	85719	United States
Cedars-Sinai Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome
D000086382	COVID-19

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D011024	Pneumonia, Viral

Browse Leaves

Not provided

Browse Branches

Not provided