Actively Recruiting
Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-01-23
5000
Participants Needed
1
Research Sites
537 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 0-99 years, including viable newborns
- Known or suspected current or past infection with SARS-CoV-2 or another emerging respiratory virus, typically supported by a positive PCR test
- Uninfected despite heavy exposure to the virus in the workplace or home environment
- Biological relative of an enrolled participant, including parents, siblings, children, grandparents, aunts, uncles, or first cousins
- Able to provide informed consent if uninfected or a relative
- Willing to allow genetic testing
- Willing to allow storage of samples and data for future research
You will not qualify if you...
- Any condition that the investigator believes makes participation unsafe or inappropriate
- Positive testing for other respiratory viruses does not exclude participation if there is suspicion of infection with the virus of interest
- Participants may be co-enrolled in other studies but must notify study staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Niaid/Lcim
Rockville, Maryland, United States, 20892
Actively Recruiting
Research Team
M
Margaret A Abaandou
CONTACT
H
Helen C Su, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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