SARS-CoV-2EPIC3NCT05764083
Epidemiology, Immunology and Clinical Characteristics of COVID-19 (EPIC3)
An observational study of SARS-CoV-2 and COVID-19, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, COVID-19
- How many people
- 2,824 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2020to 30 Sep 2024
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
About this study
Official title: CSP #2028 - Epidemiology, Immunology and Clinical Characteristics of COVID-19 (EPIC3) Within the Veterans Health Administration
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.
Read the detailed description
The objective of the study is to answer key research questions about the SARS-CoV-2 infection and COVID-19 natural history, clinical outcomes, and the development of immunity while also gathering biospecimens for future study as questions emerge about this new pathogen. The study is an observational cohort study of Veterans that is designed to gather longitudinal data on the epidemiology, virology, immunology, and clinical characteristics of the SARS-CoV-2 infection and COVID-19 disease during this early pandemic period while remaining flexible to the evolving needs of the Veterans Health Administration (VHA) system and emerging scientific questions. The study will enroll Veterans with and without SARS-CoV-2 infection in the inpatient, outpatient, and Community Living Center (CLC) extended care settings. Study procedures include questionnaires, clinical data abstraction from VHA electronic health records, and biological sampling. A key contribution of this study is to establish a research clinical and laboratory data repository and related research specimen repository, and participant registry for future studies of COVID-19, which is a newly emerging pandemic disease, and other health conditions. Finally, a long-term goal of this study is to provide the lessons learned from this COVID-19 pandemic to better anticipate and manage pandemics in the future for VHA and the general population.
There are 4 primary aims to this study: (1) identify patterns of SARS-CoV-2 viral shedding from multiple body sites in inpatient Veterans with COVID-19 infection during hospitalization through 28 days of follow-up; (2) characterize development of immunity among inpatient and outpatient Veterans with COVID-19 from the first VHA encounter through 24 months; (3) determine predictors of infection and disease course, severity and related death among inpatient and outpatient Veterans with and without SARS-CoV-2 infection and/or COVID-19 disease over 24 months; and (4) determine individual and health-facility-level risk factors for infection (including asymptomatic infection) with SARS-CoV-2 among Veterans at high risk for COVID-19 disease who are living in VHA Community Living Centers.
Veterans are likely to be substantially affected by COVID-19 due to a high prevalence of risk factors for severe COVID-19 disease. Understanding demographic, medical, and social factors that confer risk for severe COVID-19 disease is critical for improving care for Veterans with COVID-19. Characterizing viral shedding of SARS-CoV-2 infection during COVID-19 illness may yield important insight about factors that affect SARS-CoV-2 transmission. Characterizing the development of immunity among persons with COVID-19 is foundational to developing effective vaccines against the disease. Better understanding transmission risk and risk factors in the setting of VHA Community Living Centers will help prevent future infections.
- Conditions
- SARS-CoV-2, COVID-19
- Keywords
- Infectious disease, Chronic diseases, Critical care, Cohort, Epidemiologic, Observational, Prospective, Specimen banking, SARS-CoV-2, COVID-19
- Medical subject headings
- COVID-19, Communicable Diseases, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Status Change
Mortality
Measured: Day 0 (enrollment) through 24 months
Secondary outcomes (2)
Viral shedding
SARS-CoV-2 RNA from respiratory or gastrointestinal sampling sites
Measured: Day 0 (enrollment) through 6 months
Immunity
SARS-CoV-2 IgM and IgG serum antibody titers
Measured: Day 0 (enrollment) through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start22 Jul 2020
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,824 participants (actual)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer S Lee, MD PhD MA, Study chair, VA Palo Alto Health Care System, Palo Alto, CANicholas L. Smith, PhD, Study chair, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764083
- Sponsor's protocol ID
- 2028
- Acronym
- EPIC3
- Status last verified
- Jul 2025
- First submitted
- 8 Mar 2023
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data may be shared dependent upon data safeguards and IRB approvals.
Publications
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.
PubMed 40538697Ross 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.
PubMed 37484899Li 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.
PubMed 40340594Huang L, Wang TM, Sugimoto JD, Heberer KR, Baraff AJ, Korpak AM, Fox AE, Morelli DK, Midthun JB, Anzueto A, Bedimo RJ, Garshick E, Chang KM, Jump RL, Ritter AS, Danaher PJ, Eastment MC, Isaacs SN, Le E, Wang GP, Smith NL, Ross JM, Shah JA, Lee JS, Wander PL. Association of SARS-CoV-2 infection with incident diabetes among U.S. Veterans in a prospective longitudinal cohort. PLoS One. 2026 Jun 26;21(6):e0351992. doi: 10.1371/journal.pone.0351992. eCollection 2026.
PubMed 42361118
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #2028 - Epidemiology, Immunology and Clinical Characteristics of COVID-19 (EPIC3) Within the Veterans Health Administration
- ClinicalTrials.gov ID
- NCT05764083
- Acronym / sponsor ID
- EPIC3 / 2028
- Conditions
- SARS-CoV-2, COVID-19
- Keywords
- Infectious disease, Chronic diseases, Critical care, Cohort, Epidemiologic, Observational, Prospective, Specimen banking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,824 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of the study is to answer key research questions about the SARS-CoV-2 infection and COVID-19 natural history, clinical outcomes, and the development of immunity while also gathering biospecimens for future study as questions emerge about this new pathogen. The study is an observational cohort study of Veterans that is designed to gather longitudinal data on the epidemiology, virology, immunology, and clinical characteristics of the SARS-CoV-2 infection and COVID-19 disease during this early pandemic period while remaining flexible to the evolving needs of the Veterans Health Administration (VHA) system and emerging scientific questions. The study will enroll Veterans with and without SARS-CoV-2 infection in the inpatient, outpatient, and Community Living Center (CLC) extended care settings. Study procedures include questionnaires, clinical data abstraction from VHA electronic health records, and biological sampling. A key contribution of this study is to establish a research clinical and laboratory data repository and related research specimen repository, and participant registry for future studies of COVID-19, which is a newly emerging pandemic disease, and other health conditions. Finally, a long-term goal of this study is to provide the lessons learned from this COVID-19 pandemic to better anticipate and manage pandemics in the future for VHA and the general population.
There are 4 primary aims to this study: (1) identify patterns of SARS-CoV-2 viral shedding from multiple body sites in inpatient Veterans with COVID-19 infection during hospitalization through 28 days of follow-up; (2) characterize development of immunity among inpatient and outpatient Veterans with COVID-19 from the first VHA encounter through 24 months; (3) determine predictors of infection and disease course, severity and related death among inpatient and outpatient Veterans with and without SARS-CoV-2 infection and/or COVID-19 disease over 24 months; and (4) determine individual and health-facility-level risk factors for infection (including asymptomatic infection) with SARS-CoV-2 among Veterans at high risk for COVID-19 disease who are living in VHA Community Living Centers.
Veterans are likely to be substantially affected by COVID-19 due to a high prevalence of risk factors for severe COVID-19 disease. Understanding demographic, medical, and social factors that confer risk for severe COVID-19 disease is critical for improving care for Veterans with COVID-19. Characterizing viral shedding of SARS-CoV-2 infection during COVID-19 illness may yield important insight about factors that affect SARS-CoV-2 transmission. Characterizing the development of immunity among persons with COVID-19 is foundational to developing effective vaccines against the disease. Better understanding transmission risk and risk factors in the setting of VHA Community Living Centers will help prevent future infections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health Status Change
Time frame: Day 0 (enrollment) through 24 months
Mortality
2 secondary outcomes
Viral shedding
Time frame: Day 0 (enrollment) through 6 months
Immunity
Time frame: Day 0 (enrollment) through 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Background: PubMed 40538697Huang 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.
- Results publication: PubMed 37484899Ross 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.
- Results publication: PubMed 40340594Li 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.
- Derived from this study: PubMed 42361118Huang L, Wang TM, Sugimoto JD, Heberer KR, Baraff AJ, Korpak AM, Fox AE, Morelli DK, Midthun JB, Anzueto A, Bedimo RJ, Garshick E, Chang KM, Jump RL, Ritter AS, Danaher PJ, Eastment MC, Isaacs SN, Le E, Wang GP, Smith NL, Ross JM, Shah JA, Lee JS, Wander PL. Association of SARS-CoV-2 infection with incident diabetes among U.S. Veterans in a prospective longitudinal cohort. PLoS One. 2026 Jun 26;21(6):e0351992. doi: 10.1371/journal.pone.0351992. eCollection 2026.
- Seattle Epidemiologic Research and Information CenterLink provided by the sponsor.
- VA Cooperative Studies ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected data may be shared dependent upon data safeguards and IRB approvals.
Related trials for SARS-CoV-2
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer S Lee, MD PhD MA study chair
VA Palo Alto Health Care System, Palo Alto, CA
Nicholas L. Smith, PhD study chair
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and COVID-19, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Status Change (time frame: Day 0 (enrollment) through 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05764083, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.