NCT05471011

Brief Summary

Severe acute respiratory syndrome coronavirus 2-mediated coronavirus disease (COVID-19) is an evolutionarily unprecedented natural experiment that causes major changes to the host immune system. We propose to develop a test that accurately predicts short- and long-term (within one-year) outcomes in hospitalized COVID-19 patients broadly reflecting US demographics who are at increased risk of adverse outcomes from COVID-19 using both clinical and molecular data. We will enroll patients from a hospitalized civilian population in one of the country's largest metropolitan areas and a representative National Veteran's population.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
active not recruiting

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

Study Progress98%
Aug 2022May 2026

First Submitted

Initial submission to the registry

July 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

August 8, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

July 15, 2022

Last Update Submit

April 22, 2026

Conditions

Keywords

outcome predictionsystems biologymultiomicsalgorithmveteranshigh-risk populations

Outcome Measures

Primary Outcomes (1)

  • New onset or worsening frailty, single organ dysfunction, multi-organ dysfunction, and death within one year

    The primary outcome clinical composite endpoints that include new onset or worsening frailty, single organ dysfunction, multi organ dysfunction, and death within one year will include a follow-up period of time of at least 52 weeks after initial enrollment encounter. The assessment of time to event (outcome events will include various frailty measurement tools including short physical performance battery, laboratory test-based organ function assessment measures, and survival status as per publicly-accessible databases) will consist of calculating the time difference between first outcome event and baseline encounter date.

    From hospital admission to one year

Secondary Outcomes (1)

  • New onset or worsening frailty, single organ dysfunction, multi-organ dysfunction, and death at time of discharge

    From hospital admission to time of discharge

Study Arms (2)

civilian

Other: Blood and nasal swab sampling

Veteran

Other: Blood and nasal swab sampling

Interventions

Blood and nasal swab sampling

Veterancivilian

Eligibility Criteria

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

Symptomatic COVID-19 infected civilians and symptomatic COVID-19 infected veterans

You may qualify if:

  • Symptomatic COVID-19 infection with hospital admission
  • Age 18 and above
  • Informed consent

You may not qualify if:

  • Absence of symptomatic COVID-19 infection with hospital admission
  • Age 17 or below
  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Olive View-UCLA Education & Research Institute

Sylmar, California, 91342, United States

Location

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Bronx VA Medical Center

The Bronx, New York, 10468, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Deng MC. Multi-dimensional COVID-19 short- and long-term outcome prediction algorithm. Expert Rev Precis Med Drug Dev. 2020;5(4):239-242. doi: 10.1080/23808993.2020.1785286. Epub 2020 Jun 24. No abstract available.

    PMID: 33283045BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and nasal swab

MeSH Terms

Conditions

COVID-19Post-Acute COVID-19 SyndromeMultiple Organ FailureFrailty

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 15, 2022

First Posted

July 22, 2022

Study Start

August 8, 2022

Primary Completion

April 30, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

After our data is cleaned, quality checked, and analyzed, we will make the data available to the general research community. Data collected in this proposal will be submitted to the appropriate public databases (e.g. Gene Expression Omnibus), along with complete documentation to enable efficient use of the data by the general research community. Cumulative datasets will be submitted on a regular basis in a timely manner. All data made available for public use will be de-identified data, i.e., stripped of private, protected health information that could be used to deduce the identity of individual subjects, in compliance with the HIPPA Privacy Rule. The study will be registered in the database of Genotypes and Phenotypes and the following data and information will be shared through the Sequence Read Archive and Gene Expression Omnibus.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will be available following the completion of the study and will be available indefinitely.
Access Criteria
COPA Study website to be determined

Locations