Recruiting

Immune Responses

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT04582903

Conditions

COVID-19 Infection

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Background:

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). The global outbreak of COVID-19 is a major public health problem. COVID-19 causes a wide range of symptoms. These symptoms range from mild breathing problems to life-threatening problems or death. Some people have no symptoms. This study aims to learn how acute and late immune responses to COVID-19 lead to different outcomes. The immune system is the body s defense against germs, including viruses, that invade the body.

Objective:

To characterize the immune responses during and after SARS-CoV-2 infection and determine if there is any relationship to clinical course and outcome.

Eligibility:

People ages 0 99 who have confirmed or suspected SARS-CoV-2 infection, people who are not infected despite heavy exposure, and relatives of enrolled participants.

Design:

This is a sample collection protocol to receive send-in biological specimens for exploratory studies, including gene testing. Participants will not be seen at the NIH for study visits.

Study staff will talk with participants health care providers to screen them for the study. Participants enrolled into the protocol will send samples and clinical information at least once and more often if the participant has COVID-19. All participants will provide blood samples and possibly stool. We may also ask for left over specimens from any medical procedures completed as part of medical care. The study staff will also request participants health care providers to complete a survey to collect demographic and medical data. Some of this information may need to be provided directly by the participant.

Pregnant individuals are invited to participate and may be asked to give cord blood samples after delivery. Study findings that affect participants health may be shared with their health care provider. Depending on findings, participants may be contacted to take part in other NIH studies.

Conditions

COVID-19 Infection

Study ID

NCT04582903

Start date

Oct 13, 2020

Status verified date

Sep 4, 2026

Completion date

Jan 31, 2031

Anticipated

Primary completion date

Aug 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

Participants enrolled onto this protocol must meet all of the following criteria:

1. Aged 0-99 years (including viable neonates).
2. Meets one of the following criteria:

1. Patient with a known or suspected diagnosis of infection (past or current) with SARS-CoV-2 or an emerging or re-emerging respiratory virus, typically but not always supported by a positive PCR test for viral RNA;
2. Individual who has remained uninfected with negative virus serologies despite heavy or extensive exposure to the emerging or re-emerging respiratory virus in the workplace or home environment; or
3. Biological relative of a participant being studied under this protocol. Relatives may be biological mother, father, siblings, children, grandparents, aunts, uncles, or first cousins.
3. For individuals considered for enrollment as uninfected individuals and biological relatives, able to provide informed consent.
4. Willing to allow genetic testing.
5. Willing to allow storage of samples and data for future research.

EXCLUSION CRITERIA:

Individuals meeting any of the following criteria will be excluded from study participation:

1\. Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Since patients can be concurrently infected with multiple respiratory viruses, positive testing for other viruses such as rhinovirus, influenza virus, etc., does not exclude an individual from study participation where there remains a high clinical suspicion of infection with the emerging or re-emerging respiratory virus of interest despite negative testing for it.

Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Biological Relative

Biological relative of a participant being studied under this protocol. Relatives may be biological mother, father, siblings, children, grandparents, aunts, uncles, or first cousins

Confirmed or Suspected SARS-CoV-2 infection

Patient with a known or suspected diagnosis of SARS-CoV-2 infection (past or current), typically but not always supported by a positive PCR test for viral RNA

Exposed but Uninfected

Individual who has remained uninfected with negative SARS-CoV-2 serologies despite heavy or extensive COVID-19 exposure in the workplace or home environment

Primary outcome measure

  • Characterization of the dynamic changes of innate and adaptive immune responses during SARS CoV 2 infection and convalescence. [ Time Frame: End of Study ]
  • Identification of genetic variants that are associated with either severe/lethal COVID-19 or resistance to SARS CoV 2 infection. [ Time Frame: End of Study ]
  • Measurement of proinflammatory/anti inflammatory cytokines produced during SARS CoV 2 infection and convalescence, including the IFN signature response. [ Time Frame: End of Study ]
  • Survey of other potential blood proteomic biomarkers of disease. [ Time Frame: End of Study ]
  • Characterization of serological responses against SARS CoV 2, other viruses or microbiota, and host antigens. [ Time Frame: End of Study ]
  • Characterization of intrapatient SARS-CoV-2 genetic variation and evolution during infection and convalescence. [ Time Frame: End of Study ]

Central Contacts and Locations

Central contacts

Margaret A Abaandou

(301) 332-4870margaret.abaandou@nih.gov

Helen C Su, M.D.

(301) 451-8783hsu@mail.nih.gov

Locations

Niaid/Lcim

Recruiting

Rockville, Maryland, United States, 20892

Contacts

Helen Su, M.D. Ph. D

301-451-8783hsu@niaid.nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Sep 9, 2026

Last verified

Sep 4, 2026

Keywords

  • severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
  • Repository
  • Pandemic
  • Genetics
  • Proteomics
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-09-09.