Respiratory Virus Sampling and Repository

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT05266222
Collaborator
(none)
20,000
2
112.7
10000
88.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Study Description:

    Retrospective and prospective samples from participants will be obtained to isolate respiratory viruses for use in laboratory assays, animal experiments, development of challenge virus, and development of vaccines. Samples will also be obtained to study respiratory virus-associated systemic and mucosal immunity and virus characteristics.

    Objectives:
    Primary Objective:

    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.

    Study Population: 1-200 (for each virus species/strain) adult and child participants aged 3 years and above with suspected or documented respiratory infection for a maximum of 20000 participants total. The total number of subjects enrolled will depend on the prevalence of infection with each virus/strain and on the geographic distribution of infections.

    Description of Sites/Facilities Enrolling Participants:

    NIH Clinical Center (CC).

    Study Duration: 10 years

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Respiratory Virus Sampling and Repository
    Actual Study Start Date :
    Aug 11, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2031
    Anticipated Study Completion Date :
    Dec 31, 2031

    Arms and Interventions

    Arm Intervention/Treatment
    People with respiratory infection

    Persons with suspected or documented respiratory infection

    Outcome Measures

    Primary Outcome Measures

    1. To isolate human respiratory virus specimens [10 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:

    In order to be eligible to participate in this study, an individual must meet all of the following criteria:

    1. Aged 3 years or older.

    2. Documented or suspected infection with a respiratory virus.

    3. Stated willingness to comply with all study procedures for the duration of the study.

    EXCLUSION CRITERIA:

    An individual who meets any of the following criteria will be excluded from participation in this study:

    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center Bethesda Maryland United States 20892
    2 NIH Building 33 (NIAID) Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Principal Investigator: Matthew J Memoli, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT05266222
    Other Study ID Numbers:
    • 10000707
    • 000707-I
    First Posted:
    Mar 4, 2022
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    May 12, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2022