Respiratory Virus Sampling and Repository

Recruiting

• Conditions: Influenza; COVID-19

• Registration Number: NCT05266222
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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 Timeline

• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-04
• Study Start: 2022-08-11
• Status Verified: 2023-10-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States

NIH Building 33 (NIAID); 🇺🇸 Bethesda, Maryland, United States