Analyzing immune responses to COVID-19 through sample collection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.