A Global Effort to Define the Human Genetics of Protective Immunity to SARS-CoV-2 Infection.
Jean-Laurent Casanova, Helen C Su, COVID Human Genetic Effort
https://pubmed.ncbi.nlm.nih.gov/32405102Actively Recruiting
Age: 1Day - 99Years
All Genders
Healthy Volunteers
ID04582903
Send-In Sample Collection for Immune Response Analyses During and After Acute Infections With Emerging or Re-emerging Respiratory Viruses
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-01-23
5000
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the immune responses during and after infection with SARS-CoV-2, the virus that causes COVID-19, and other emerging respiratory viruses. The study aims to understand how these immune responses relate to the course and outcomes of the illness. It includes participants across a wide age range from newborns to 99 years old, including those infected, uninfected despite exposure, and biological relatives of infected individuals. Participants send in biological samples such as blood, saliva, stool, urine, and leftover clinical specimens for detailed genetic, immunologic, molecular, and virologic analyses. These samples are collected over time from those with confirmed or suspected infection, uninfected individuals with heavy exposure, and biological relatives. The study does not involve in-person visits at the NIH but collects data and specimens remotely. Participants provide samples at least once and more often if infected, along with clinical and demographic information from their health care providers. Pregnant participants may be asked to provide cord blood after delivery. Researchers measure immune system changes, genetic variants linked to disease severity or resistance, inflammatory markers, antibody responses, and viral genetic variations. Relevant findings may be shared with participants and their health care providers. The study continues through the infection and convalescence phases to gather comprehensive immune response data.
CONDITIONS
Brief Title
Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence
Who Can Participate
Age: 1Day - 99Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Aged 0 to 99 years, including viable newborns
- Have confirmed or suspected infection with SARS-CoV-2 or other emerging respiratory viruses
- Have remained uninfected despite heavy exposure to these viruses at work or home
- Be a biological relative of a participant already enrolled, including parents, siblings, children, grandparents, aunts, uncles, or first cousins
- Able and willing to provide informed consent
- 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 prevents safe participation in the study
- 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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
No in-person visits; samples are sent in by participants.
Sample Collection
Duration - Varies based on participant infection status and convalescence period
Participants send in biological samples such as blood, saliva, stool, urine, and leftover clinical samples for research evaluation.
Participants send samples longitudinally without in-person visits.
Long-term Monitoring
Duration - Up to study completion in 2031
Participants' immune responses are characterized over time through analysis of sent-in samples, including genetic, immunologic, molecular, and virologic assessments.
No visits; ongoing sample submission as per participant status.
Trial Site Locations
Total: 1 location
1
Niaid/Lcim
Rockville, Maryland, United States, 20892
Actively Recruiting
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Research Team
M
Margaret A Abaandou
H
Helen C Su, M.D.
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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Published Research Related To This Trial
Sensitivity in Detection of Antibodies to Nucleocapsid and Spike Proteins of Severe Acute Respiratory Syndrome Coronavirus 2 in Patients With Coronavirus Disease 2019.
Peter D Burbelo, Francis X Riedo, Chihiro Morishima...
https://pubmed.ncbi.nlm.nih.gov/32427334Coronavirus: Update Related to the Current Outbreak of COVID-19.
Giovanni Gabutti, Erica d'Anchera, Federica Sandri...
https://pubmed.ncbi.nlm.nih.gov/32292686