Respiratory Virus Sampling and Repository

NCT05266222 | Recruiting

• 2 other identifiers: 10000707000707-I
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Respiratory viruses, like the flu or COVID-19, cause significant illness and death worldwide. Researchers want to collect samples from people with respiratory virus infections. The samples in this natural history study will be used in future research. Objective: To obtain samples from people with respiratory viruses to learn more about respiratory virus infections and the immune responses against them. Eligibility: People aged 3 and older who have or are suspected to have a respiratory virus infection. Design: Participants will be screened with a medical record review. Participants will give blood samples. Data from their medical records will be collected. Participants will give nose samples. A soft plastic strip will be put into each nostril for a minute. They may also give nose, mouth (back of the throat), or saliva samples using swabs. Participants may receive kits by mail to collect nose and blood samples at home. They will use soft plastic strips to collect nose samples. To collect blood, they will prick their finger and dab a few drops of blood on four plastic tips. If a participant is in the hospital, air samples may be collected in their room. Participation will last for up to 2 years. After 2 years, participants may be asked for their consent again to give new samples and new medical data.

Conditions

Influenza; COVID-19

Keywords

Influenza; Flu; COVID; Coronavirus; Immunity; Natural History

Outcome Measures

Primary Outcomes (1)

• To isolate human respiratory virus specimens

  To isolate human respiratory virus specimens and maintain them in a repository for future use in laboratory assays, animal experiments, development of challenge viruses, and development of vaccines, described in a separate protocol.

  10 years

Study Arms (1)

People with respiratory infection

Persons with suspected or documented respiratory infection

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons with suspected or documented respiratory infection

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Aged 3 years or older.
• Documented or suspected infection with a respiratory virus.
• Stated willingness to comply with all study procedures for the duration of the study.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• \. Any condition that, in the opinion of the investigator, would compromise the safety of the study participant or staff, or would prevent proper conduct of the study.
• Non-English Speaking Participants: This study will enroll non-English speaking participants.
• For non-English speaking participants, the study will be explained to the participant/family through an interpreter, in the presence of the study team, in the language understood by the participant/family. The short form in the language understood by the participant/family will be signed by the participant/family or LAR and the interpreter, and the consent will be signed by the consenting provider and the interpreter.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

NIH Building 33 (NIAID)

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Influenza, Human; COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronaviridae Infections; Nidovirales Infections; Lung Diseases

Study Officials

• Matthew J Memoli, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rani S Athota, Ph.D.

CONTACT

(301) 594-0803; rani.athota@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 4, 2022
• Study Start: August 11, 2022
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 8, 2026

Record last verified: 2025-09-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)