Studying Viral Infections in Healthy and Immunocompromised People
Viral Infections in Healthy and Immunocompromised Hosts
Recruiting
Observational Study
Anogenital HerpesCOVID-19Herpes Labialis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 Months – 120
Sex
Any
Study type
Observational
Participants needed
1,000 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
Who this trial is looking for
This trial is looking for individuals of all ages who have a viral infection or have been in close contact with someone who does. Participants will provide samples and information to help researchers understand these infections better.
Are You a Good Fit for This Trial?
You may be able to join if
I am 2 years old or older.
I have been diagnosed with a viral infection.
I suspect I have a viral infection.
I have recently been in close contact with someone with a viral infection.
I recently had a viral infection that has cleared.
I am a healthy person and am 18 years old or older.
You may not be able to join if
I am unable to safely undergo study procedures and tests.
I am unwilling to have samples collected and stored.
I am under 18 years old.
I am a decisionally impaired adult.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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Status
Eligibility 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.…
* 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
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