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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: Enrolling by Invitation
Gender: Male & Female
Min Age: 0
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

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

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.

3. Adults who are unable to provide initial consent may be enrolled providing procedures per Human Research Protections Program (HRPP) standard operation procedure (SOP) 14E have been followed.

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.

INCLUSION OF VULNERABLE PARTICIPANTS:

-Children:

Children younger than 2 years of age will be enrolled only remotely from non-NIH medical facilities and will not be seen at the Clinical Center, because children of this age are susceptible to viral infections, some of which are more likely to occur in this very young population or could be more severe. Title 45 of the United States Code of Federal Regulations (CFR) Part 46 Subpart D and (OHRSPHRPP SOP 14D) will be followed to comply with research involving children. The proposed research poses a risk no greater than that encountered with blood tests or other minimally invasive tests ordered as part of a routine history and physical examination. The PI will ensure that appropriate permission from each child s parent(s) or guardian has been obtained for participation in this study.

-Pregnant Women:

Pregnant women are eligible to participate in this study as they are susceptible to viral infections, some of which may be more severe in this patient population. This study provides an opportunity to learn more about viral infections in pregnant women. This information may be meaningful in informing disease severity, clinical practice for treating pregnant women, or in leading to new treatments for this population. This information cannot be gained without the participation of pregnant women. The primary procedure performed under this protocol is a blood draw but other procedures may be performed and are considered minimal risk in clinical practice. No procedures that would affect a developing fetus or affect a baby through breastfeeding are performed in the protocol.

-Decisionally Impaired Adults:

Adults who are unable to provide initial informed consent are eligible to enroll. Also adults who lose the ability to provide on-going consent subsequent to giving initial consent may continue to participate. These adults are susceptible to viral infections and we can learn about viral infections that may occur in this population. Institutionalized adults will not be enrolled. The procedures utilized are clinically considered to be of minimal risk


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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

Krista S. Gangler, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 9N214
10 Center Drive
Bethesda, Maryland 20892
(301) 761-6437
krista.gangler@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: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01306084

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