A Study to Investigate Acute Respiratory Virus Infections in Participants at High Risk for Severe Illness (BREEZE)

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Viral Infection
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L8E7
      • Hamilton Health Sciences
• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford Hospital and Clinics
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants at high risk for severe respiratory infections due to their immune-suppressive status.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Clinically Confirmed Acute Respiratory Infection (ARI)	Number of participants with clinically confirmed ARI will be reported.	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.	Up to 1 year 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Clinically Confirmed ARI Participants who Were Hospitalized	Number of clinically confirmed ARI participants who were hospitalized will be reported.	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.	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.	Up to 1 year 3 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Virus Diseases
• Other Study ID Numbers: CR109291; NOPRODVIR0001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO