Acute Respiratory Viral InfectionBREEZENCT05661604
A Study to Investigate Acute Respiratory Virus Infections in Participants at High Risk for Severe Illness
An observational study of Acute Respiratory Viral Infection, run by Janssen Research & Development, LLC at 4 sites in 2 countries.
Trial summary
The purpose of the study is to describe the rate of occurrence of clinical diagnosis of acute respiratory infection (an infection that affects normal breathing) and different types of respiratory pathogens (harmful organisms) of new respiratory infections in a population at high risk for severe illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Viral Infection
- How many people
- 140 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 19 Jan 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants at high risk for severe respiratory infections due to their immune-suppressive status.
Who may be able to join
- Must sign an informed consent form (ICF) indicating understanding the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study
- Participants at high risk for severe respiratory infections due to their immune-suppressive status and who fit in one or more of the following categories: a) Participants with hematologic malignancy (HM) including, but not limited to, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (ALL), multiple myeloma (MM): i) Newly diagnosed, within 6 months of treatment initiation; including anticipation of cytotoxic and immunomodulatory therapy such as chimeric antigen receptor T (CAR-T) ii) Hematologic relapse within 6 months from anticipating treatment initiation for relapse iii) Participants with a history of HM who have maintained the immunosuppressive status in the opinion of the investigator and after consultation with the sponsor (that is, study responsible physician or scientists) b) Participants with a history of HM who have received hematopoietic cell transplant (HCT) within 1 year for autologous recipients or within 3 years for allogeneic recipients. c) Participants with a non-HM who have received HCT within 1 year for autologous recipients or within 3 years for allogeneic recipients. This can include, but is not limited to, participants who have received HCT due to lymphoproliferative disorders, solid tumors, primary immunodeficiency, bone marrow failure syndromes, hemoglobinopathies, sickle cell disease, or autoimmune disorders. d) Participants who have developed chronic graft vs host disease (GVHD) after HCT and are currently on immunosuppressive therapy
- Must be able to read, understand, and complete questionnaires
- Must be willing and able to connect current electronic health records from one or more providers
Who cannot join
- Has a clinical condition other than those specified in inclusion criterion 3 which, in the opinion of the investigator, could prevent, confound, or limit the protocol-specified assessments (for example, asthma and allergies)
- Is, in the opinion of the investigator, unlikely to adhere to the requirements of the study or is unlikely to complete the full course of observation
- Cannot communicate reliably with the investigator
- Has moderate-severe allergies that add complexity to the assessment of acute respiratory infection (ARI) episode
- Is currently enrolled in an interventional study that could interfere with the assessment of respiratory viral dynamics
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Henry Ford Hospital
Detroit, Michigan, 48202
Stanford Hospital and Clinics
Palo Alto, California, 94305
Fred Hutchinson Research Center
Seattle, Washington, 98109
About this study
Official title: Prospective Study to Investigate Acute Respiratory Virus Infections in Patients at High Risk for Severe Illness
The purpose of the study is to describe the rate of occurrence of clinical diagnosis of acute respiratory infection (an infection that affects normal breathing) and different types of respiratory pathogens (harmful organisms) of new respiratory infections in a population at high risk for severe illness.
- Conditions
- Acute Respiratory Viral Infection
- Being tested
- No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is an observational study to assess the incidence and key disease characteristics of symptomatic acute respiratory viral infections in a high-risk population at risk for poor outcomes. Duration of each participant will be up to 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Participants at High Risk for Poor Outcomes From a Respiratory Infection | Data will be collected for participants at high risk for poor outcomes from a respiratory infection. The duration of participation per participant will be up to 12 months. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Clinically Confirmed Acute Respiratory Infection (ARI)
Number of participants with clinically confirmed ARI will be reported.
Measured: Up to 1 year 3 months
Number of Clinically Confirmed ARI Participants With Positive or Negative Infection Status for Each Respiratory Virus Tested
Number of clinically confirmed ARI participants with positive or negative infection status for each respiratory virus tested will be reported.
Measured: Up to 1 year 3 months
Secondary outcomes (3)
Number of Clinically Confirmed ARI Participants who Were Hospitalized
Number of clinically confirmed ARI participants who were hospitalized will be reported.
Measured: Up to 1 year 3 months
Number of Clinically Confirmed ARI Participants who Experienced Complications
Number of clinically confirmed ARI participants who experienced complications will be reported.
Measured: Up to 1 year 3 months
Number of Deaths in Clinically Confirmed ARI Participants
Number of deaths in clinically confirmed ARI participants will be reported.
Measured: Up to 1 year 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start19 Jan 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Viral InfectionStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661604
- Sponsor's protocol ID
- CR109291
- Other IDs
- NOPRODVIR0001
- Acronym
- BREEZE
- Status last verified
- Feb 2025
- First submitted
- 15 Dec 2022
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Investigate Acute Respiratory Virus Infections in Patients at High Risk for Severe Illness
- ClinicalTrials.gov ID
- NCT05661604
- Acronym / sponsor ID
- BREEZE / CR109291
- Conditions
- Acute Respiratory Viral Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 22 Dec 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.
The purpose of the study is to describe the rate of occurrence of clinical diagnosis of acute respiratory infection (an infection that affects normal breathing) and different types of respiratory pathogens (harmful organisms) of new respiratory infections in a population at high risk for severe illness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants at High Risk for Poor Outcomes From a Respiratory Infection | – | Other: No InterventionData will be collected for participants at high risk for poor outcomes from a respiratory infection. The duration of participation per participant will be up to 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants at high risk for severe respiratory infections due to their immune-suppressive status.
Key inclusion criteria (4 listed)
- Must sign an informed consent form (ICF) indicating understanding the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study
- Participants at high risk for severe respiratory infections due to their immune-suppressive status and who fit in one or more of the following categories: a) Participants with hematologic malignancy (HM) including, but not limited to, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (ALL), multiple myeloma (MM): i) Newly diagnosed, within 6 months of treatment initiation; including anticipation of cytotoxic and immunomodulatory therapy such as chimeric antigen receptor T (CAR-T) ii) Hematologic relapse within 6 months from anticipating treatment initiation for relapse iii) Participants with a history of HM who have maintained the immunosuppressive status in the opinion of the investigator and after consultation with the sponsor (that is, study responsible physician or scientists) b) Participants with a history of HM who have received hematopoietic cell transplant (HCT) within 1 year for autologous recipients or within 3 years for allogeneic recipients. c) Participants with a non-HM who have received HCT within 1 year for autologous recipients or within 3 years for allogeneic recipients. This can include, but is not limited to, participants who have received HCT due to lymphoproliferative disorders, solid tumors, primary immunodeficiency, bone marrow failure syndromes, hemoglobinopathies, sickle cell disease, or autoimmune disorders. d) Participants who have developed chronic graft vs host disease (GVHD) after HCT and are currently on immunosuppressive therapy
- Must be able to read, understand, and complete questionnaires
- Must be willing and able to connect current electronic health records from one or more providers
Key exclusion criteria (5 listed)
- Has a clinical condition other than those specified in inclusion criterion 3 which, in the opinion of the investigator, could prevent, confound, or limit the protocol-specified assessments (for example, asthma and allergies)
- Is, in the opinion of the investigator, unlikely to adhere to the requirements of the study or is unlikely to complete the full course of observation
- Cannot communicate reliably with the investigator
- Has moderate-severe allergies that add complexity to the assessment of acute respiratory infection (ARI) episode
- Is currently enrolled in an interventional study that could interfere with the assessment of respiratory viral dynamics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is an observational study to assess the incidence and key disease characteristics of symptomatic acute respiratory viral infections in a high-risk population at risk for poor outcomes. Duration of each participant will be up to 12 months. | Other | Participants at High Risk for Poor Outcomes From a Respiratory Infection |
Primary outcome
Number of Participants with Clinically Confirmed Acute Respiratory Infection (ARI)
Time frame: Up to 1 year 3 months
Number of participants with clinically confirmed ARI will be reported.
Number of Clinically Confirmed ARI Participants With Positive or Negative Infection Status for Each Respiratory Virus Tested
Time frame: Up to 1 year 3 months
Number of clinically confirmed ARI participants with positive or negative infection status for each respiratory virus tested will be reported.
3 secondary outcomes
Number of Clinically Confirmed ARI Participants who Were Hospitalized
Time frame: Up to 1 year 3 months
Number of Clinically Confirmed ARI Participants who Experienced Complications
Time frame: Up to 1 year 3 months
Number of Deaths in Clinically Confirmed ARI Participants
Time frame: Up to 1 year 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Viral Infection, run by Janssen Research & Development, LLC at 4 sites in 2 countries.
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 5 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: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Clinically Confirmed Acute Respiratory Infection (ARI) (time frame: Up to 1 year 3 months). The study lists 2 primary outcomes in all. 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 28 Feb 2025.