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Protocol Details

Viral Infections in Healthy and Immunocompromised Hosts

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

11-I-0109

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 6 Mo
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

SARS-CoV-2;
Respiratory Infections;
Norovirus;
Adenovirus;
Coronavirus;
Natural History

Recruitment Keyword(s)

Viral Infection;
Respiratory Viruses

Condition(s)

Anogenital Herpes;
COVID-19;
Herpes Labialis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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.

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Eligibility

INCLUSION CRITERIA:

1. The protocol is open to people of all ages:

i. Only patients greater than or equal to 2 years of age can be enrolled at the Clinical Center.

ii. Patients who are < 2 years old may be enrolled only remotely and will not be seen at the Clinical Center.

2. Must have (or be suspected of having) a viral infection that is of interest to LID investigators. Alternatively, must be 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.

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Jeffrey I. Cohen, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)


jcohen@niaid.nih.gov

Jeffrey I. Cohen, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 50 BG RM 6134
50 SOUTH DR
BETHESDA MD 20892
(301) 496-5265
jcohen@niaid.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01306084

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