No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
1 Day – 99
Sex
Any
Study type
Observational
Participants needed
5,000 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
Who this trial is looking for
This trial is looking for people of all ages who have been infected with or exposed to COVID-19 or respiratory viruses. Participants will send in samples like blood and possibly stool for analysis without needing to visit the study site.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 0 and 99 years old.
I have a known or suspected COVID-19 infection.
I have not been infected despite frequent exposure to COVID-19.
I am a biological relative of someone in this study.
I can give my consent for participation.
I am willing to allow genetic testing.
I am open to storage of my samples and data for future research.
You may not be able to join if
I have a condition that my doctor thinks prevents me from joining this study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 resp…
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.
Trial Locations
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Status
Eligibility Criteria
* 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 em…
* 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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