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Massive study aims to unlock secrets of COVID-19 immunity

NCT ID NCT04582903

Knowledge-focused Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This study, run by the National Institute of Allergy and Infectious Diseases, collects blood and stool samples from up to 5,000 people of all ages who have or had COVID-19, as well as those heavily exposed but uninfected. Researchers will analyze immune responses and genetic factors to understand why outcomes vary so widely. No treatments are tested—this is purely a knowledge-gathering effort to guide future therapies and vaccines.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal why some people get very sick from COVID-19 while others don't, pointing toward better treatments and vaccines.
What could go wrong
This is an early, exploratory study that only collects samples—it does not test any treatment. Findings may not lead to direct benefits for participants or the public.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

We plan to enroll up to 500 total participants in this protocol, including up to 300 patients with SARS-CoV-2 infection and 200 other participants (patient relatives and individuals who remain uninfected despite heavy or extensive COVID-19 exposure in the workplace or home environment). Health care providers worldwide will contact the study staff to request enrollment of patients and/or their relatives. Additionally, investigators may refer patients from other clinical studies.

Ages

1 day to 99 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19 infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Niaid/Lcim

    RECRUITING

    Rockville, Maryland, 20892, United States

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