Analyzing immune responses to COVID-19 through sample collection
Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute Infections With, and Convalescence From, Emerging or Re-emerging Respiratory Viruses
This study is testing how the immune system reacts to COVID-19 by collecting samples from people who have had the virus and those who haven't, to see what this means for their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 1 Day to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Rockville, Maryland) |
| Trial ID | NCT04582903 on ClinicalTrials.gov |
What this trial studies
This study aims to characterize the innate and adaptive immune responses during and after SARS-CoV-2 infection. Participants, aged 0 to 99, will send in biological samples such as blood and saliva for analysis. The goal is to understand how these immune responses relate to clinical outcomes in COVID-19 patients and those exposed but uninfected. The study will involve up to 300 patients with confirmed or suspected infections and 200 uninfected individuals or their relatives. This approach allows for remote participation without the need for in-person visits.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 0-99 with confirmed or suspected SARS-CoV-2 infection, those uninfected despite heavy exposure, and their biological relatives.
Not a fit: Patients who do not have a confirmed or suspected SARS-CoV-2 infection and are not related to enrolled participants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of immune responses to COVID-19, potentially leading to improved treatments and preventive measures.
How similar studies have performed: Other studies have successfully characterized immune responses to viral infections, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Rockville, Maryland
- Niaid/Lcim — Rockville, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Helen C Su, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Margaret A Abaandou
- Email: margaret.abaandou@nih.gov
- Phone: (301) 332-4870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.