Epidemiology, Immunology and Clinical Characteristics of COVID-19 (EPIC3)

NCT05764083 | Completed

• 1 other identifier: 2028
• Study Type: observational
• Target: 2,824
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to gather information to answer questions about the Coronavirus Disease 2019 (COVID-19) which is caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. This study will collect information and biological specimens from participants who have been tested for the SARS-CoV-2 infection. By doing this study, the investigators hope to learn important new information about SARS-CoV-2 infections and the potentially severe outcomes of COVID-19 to find better ways to manage and treat it in the future. The investigators also hope to learn what makes some people more susceptible to infection to help better inform Veterans on how to reduce their risk of infection. This study also involves the development and maintenance of a participant registry, a data repository, and a biorepository for future research.

Conditions

SARS-CoV-2; COVID-19

Keywords

Infectious disease; Chronic diseases; Critical care; Cohort; Epidemiologic; Observational; Prospective; Specimen banking; SARS-CoV-2; COVID-19

Outcome Measures

Primary Outcomes (1)

• Health Status Change

  Mortality

  Day 0 (enrollment) through 24 months

Secondary Outcomes (2)

• Viral shedding

  Day 0 (enrollment) through 6 months

• Immunity

  Day 0 (enrollment) through 6 months

Study Arms (3)

Inpatient Cohort

COVID-19-positive or -suspected inpatients: Eligible inpatient cohort participants include Veterans who receive inpatient care at VHA facilities and are tested for SARS-CoV-2. Members of this inpatient cohort include those with and without SARS-CoV-2 infection.

Outpatient Cohort

COVID-19-positive or -suspected outpatients: Eligible outpatient cohort participants include Veterans who seek care in (1) VA medical center emergency departments, (2) VA medical center urgent care clinics, or (3) VA medical center COVID-19-specific testing sites, and who are tested for SARS-CoV-2 but do not require hospital admission at the time of evaluation. Members of this outpatient cohort include those with and without SARS-CoV-2 infection.

Community Living Center Cohort

Community Living Center residents: Eligible Community Living Center cohort participants include all residents who reside in VA medical center-operated Community Living Centers. Members of this Community Living Center cohort include those with and without SARS-CoV-2 infection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is VA medical center inpatients, outpatients, and residents at Community Living Centers who meet the inclusion and exclusion criteria and are receiving healthcare at one of the VHA medical centers serving as study sites.

You may qualify if:

• Eligible inpatient cohort participants include Veterans with confirmed, suspected, or unsuspected COVID-19 who receive inpatient care at VHA facilities
• Eligible outpatient cohort participants include Veterans who seek care in (1) VA medical center emergency departments, (2) VA medical center urgent care clinics, or (3) VA medical center COVID-19-specific testing sites, and who are tested for SARS-CoV-2 but do not require hospital admission at the time of evaluation
• Eligible Community Living Center cohort participants include all residents who reside in VA medical center-operated Community Living Centers

You may not qualify if:

• Veterans without a legally authorized representative who are unable to provide consent
• Potential participants who are not Veterans
• Veterans who are illiterate or have limited or no English language proficiency

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Related Publications (3)

• Huang L, Li X, Kamal SI, Sugimoto JD, Liu CH, Wang T, Morelli DK, Midthun JB, Pakanati VR, Deardorff KV, Sporleder JL, Lopez J, Holodniy M, Smith NL, Lee JS, Shah JA, Ross JM. Epidemiology, Immunology and Clinical Characteristics of COVID-19 (EPIC3)-Database of a prospective longitudinal observational study within the Veterans Health Administration. Front Public Health. 2025 Jun 2;13:1535315. doi: 10.3389/fpubh.2025.1535315. eCollection 2025. No abstract available.

  PMID: 40538697 BACKGROUND

• Ross JM, Sugimoto JD, Timmons A, Adams J, Deardoff K, Korpak A, Liu C, Moore K, Wilson D, Bedimo R, Chang KM, Cho K, Crothers K, Garshick E, Gaziano JM, Holodniy M, Hunt CM, Isaacs SN, Le E, Jones BE, Shah JA, Smith NL, Lee JS; EPIC Investigators. Early Outcomes of SARS-CoV-2 Infection in a Multisite Prospective Cohort of Inpatient Veterans. Open Forum Infect Dis. 2023 Jun 27;10(7):ofad330. doi: 10.1093/ofid/ofad330. eCollection 2023 Jul.

  PMID: 37484899 RESULT

• Li X, Pakanati V, Liu C, Wang T, Morelli D, Korpak A, Baraff A, Isaacs SN, Vittor A, Chang KM, Le E, Smith NL, Lee JS, Ross JM, Shah JA; EPIC3 Investigators. Peripheral blood cytokine profiles predict the severity of SARS-CoV-2 infection: an EPIC3 study analysis. BMC Infect Dis. 2025 May 8;25(1):677. doi: 10.1186/s12879-025-10914-6.

  PMID: 40340594 RESULT

Related Links

• Seattle Epidemiologic Research and Information Center
• VA Cooperative Studies Program

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab, oropharyngeal swab, blood, saliva, stool, sputum, rectal swab, urine, and other residual clinical samples including cerebrospinal fluid and tissue

MeSH Terms

Conditions

COVID-19; Communicable Diseases; Chronic Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer S Lee, MD PhD MA

  VA Palo Alto Health Care System, Palo Alto, CA

  STUDY CHAIR

• Nicholas L. Smith, PhD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Years
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 10, 2023
• Study Start: July 22, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Data will be made available for sharing 1 year after the publication of the last manuscript addressing the primary aims of the study.
• Access Criteria: The VA Cooperative Studies Program (CSP) has a program for sharing CSP study data: Integrated Veteran Epidemiologic Study Data Resource (INVESTD-R). The INVESTD-R website is where information is provided on CSP studies with data that can be shared for secondary analyses or to support new data collection from study members who consented to be recontacted. Data will be shared with qualifying investigators at bona fide research institutions.

Locations

US (1)