Viral Infections in Healthy and Immunocompromised Hosts
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study ID
- NCT01306084
- Status
- Recruiting
Conditions
- Anogenital Herpes
- COVID-19
- Herpes Labialis
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Months - 120 Years
- Healthy Volunteers
- Accepted
Study Details
Background: \- Viral infections are an important cause of illness and death in hospitalized patients as well as outpatients. New strains of viruses may appear and infect both healthy people and those with weak immune systems. A better understanding of these new virus strains (such as SARS-CoV-2, the virus that causes COVID-19) may help to control and prevent these infections. In particular, some viral infections that are less problematic in healthy persons can be life threatening in persons with weak immune systems, and viruses may be able to evolve more rapidly in persons with weak immune systems and therefore develop resistance to existing treatments. Researchers are interested in collecting samples and information from otherwise healthy persons or persons with weak immune systems to study the effects of viruses and their development. Objectives: \- To collect samples and data from individuals who have been exposed to or have contracted viral infections. Eligibility: * Individuals of all ages who have been diagnosed with a viral infection are suspected to have a viral infection, or have been in close contact with someone with a suspected or actual viral infection that is of interest to investigators in the Laboratory of Infectious Diseases. * Healthy persons and persons with weak immune systems (immunocompromised individuals) are eligible to participate. Design: * Participants will be pre-screened to determine if they meet the eligibility criteria for the trial. * If eligible, evaluation may include a medical chart review, a history and physical examination, review of clinical reports from outside hospitals and laboratories, and review of tissue biopsies. * Study procedures may include collection of blood, urine, saliva, nasal fluid sampling, throat swabs, stool, and genital swabs. For participants who have specimens collected as part of their medical care (e.g. wound swabs, spinal tap, bronchoscopy, liver biopsy etc.), researchers may use leftover specimens from the clinical laboratory for testing. * Specimens may be collected up to 4 times per week during the first 2 weeks after enrollment, and then as many as 2 times per week for up to 2 years. Some participants may be asked to continue providing specimens if there is concern for relapse or recurrence of the infection. * Treatment is not offered under this study.
Key Dates
- Start date
- Mar 15, 2011
- Status verified
- Nov 2025
Study Design
- Enrollment
- 1,000 participants (estimated)
Arms
- Arm: 1NIH campus employees who have recently recovered from COVID-19
- Arm: 2Clinical Center health care workers and ancillary staff who have close patient contact and possible exposures to SARS-CoV-2
- Arm: 3Healthy and immunocompromised subjects who have or are suspected to have a viral infection
- Arm: 4Healthy and immunocompromised subjects exposed to someone who has a viral infection or is suspected of having a viral infection
- Arm: 5Healthy subjects who grew up in dengue endemic areas.
- Arm: 6Healthy subjects with a history of viral hepatitis
Primary Outcome Measure
Sample collection, analysis of immune function, or review of tissue biopsies or clinical reports from outside laboratories in designated populations with viral infections, suspected of having a viral infection, recovered from a viral infection o... [ Time Frame: open-ended ]
Central Contacts
- Jeffrey I Cohen, M.D.(301) 496-5265
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | - |
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