Respiratory Virus Sampling and Repository

RECRUITING

I'm interested ...!!

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

🗓️ Study Start (Actual) 11 August 2022

🗓️ Primary Completion (Estimated) 31 December 2031

✅ Study Completion (Estimated) 31 December 2031

👥 Enrollment (Estimated) 20000

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Bethesda, Maryland, United States

📋 Eligibility Criteria

Description

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.

Ages Eligible for Study: 3 Years to N/A (CHILD, ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 3 March 2022
First Submitted that Met QC Criteria 3 March 2022
First Posted 4 March 2022

Study Record Updates

Last Update Submitted that Met QC Criteria 11 October 2023
Last Update Posted 12 October 2023
Last Verified 10 October 2023