Understanding viral infections in healthy and immunocompromised individuals
Viral Infections in Healthy and Immunocompromised Hosts
This study is trying to learn more about how different viral infections, like COVID-19 and herpes, affect both healthy people and those with weakened immune systems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 6 Months to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01306084 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect samples and data from individuals exposed to or infected with various viral infections, including COVID-19 and herpes viruses. Researchers will analyze these samples to understand virus evolution, resistance to antiviral treatments, and the impact of viral infections on both healthy and immunocompromised hosts. The study will involve obtaining sequential virus specimens, reviewing clinical reports, and documenting patient symptoms and histories. The goal is to enhance knowledge about how viral infections behave in different populations and improve prevention strategies.
Who should consider this trial
Good fit: Ideal candidates include individuals of all ages who have been exposed to or infected with specific viral infections, as well as healthy individuals serving as controls.
Not a fit: Patients with viral infections not of interest to the investigators or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prevention and treatment strategies for viral infections, particularly in vulnerable populations.
How similar studies have performed: Other studies have shown success in understanding viral infections and their evolution, making this approach both relevant and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA
1. The protocol is open to people of all ages;
1. Only patients greater than or equal to 2 years of age can be enrolled at the Clinical Center.
2. Patients who are less than 2 years old may be enrolled only remotely and will not be seen at the Clinical Center.
2. a. Persons having (or be suspected of having) a viral infection that is of interest to LID investigators.
b. Persons that are a close contact of someone who has (or is suspected of having) a viral infection that is of interest to LID investigators or is about to receive or have recently received a viral vaccine.
c. Persons that may have had a recent viral infection that is of interest to LID investigators that has since cleared
d. Healthy persons who will serve as controls for (a), (b), or (c) above. These persons will be 18 years of age or older and able to provide informed consent.
3. Adults who are unable to provide initial consent may be enrolled providing procedures per Human Research Protections Program (HRPP) Policy 403 have been followed.
4. Only subjects that are NIH employees or contractors who work at NIH will be enrolled in the COVID19 antibody cohort study on this protocol.
EXCLUSION CRITERIA
1. Patients who are unable to safely undergo study procedures and tests.
2. Patients unwilling to have samples collected and stored for future use.
3. For the healthy controls cohort: persons who are \<18 years old, decisionally impaired adults, and pregnant women
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey I Cohen, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Jeffrey I Cohen, M.D.
- Email: jcohen@niaid.nih.gov
- Phone: (301) 496-5265
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.