InfluenzaNCT05266222
Respiratory Virus Sampling and Repository
An observational study of Influenza and COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- How many people
- 20,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Aug 2022to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Persons with suspected or documented respiratory infection
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
- Recruiting
NIH Building 33 (NIAID)
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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
- Keywords
- Influenza, Flu, COVID, Coronavirus, Immunity, Natural History
- Medical subject headings
- Influenza, Human, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with respiratory infection | Persons with suspected or documented respiratory infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start11 Aug 2022
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Matthew J Memoli, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266222
- Sponsor's protocol ID
- 10000707
- Other IDs
- 000707-I
- Status last verified
- 7 Aug 2026
- First submitted
- 3 Mar 2022
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not working with any outside collaborators that require this information
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Virus Sampling and Repository
- ClinicalTrials.gov ID
- NCT05266222
- Acronym / sponsor ID
- 10000707
- Keywords
- Influenza, Flu, COVID, Coronavirus, Immunity, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with respiratory infection | – | –Persons with suspected or documented respiratory infection |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Persons with suspected or documented respiratory infection
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To isolate human respiratory virus specimens
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. We are not working with any outside collaborators that require this information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew J Memoli, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rani S Athota, Ph.D. ((301) 594-0803, rani.athota@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To isolate human respiratory virus specimens (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.