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

Completed

• Conditions: Acute Respiratory Viral Infection

• Registration Number: NCT05661604
• Lead Sponsor: Janssen Research & Development, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-22
• Study Start: 2023-01-19
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Clinically Confirmed ARI Participants With Positive or Negative Infection Status for Each Respiratory Virus Tested	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.
Number of Participants with Clinically Confirmed Acute Respiratory Infection (ARI)	Up to 1 year 3 months	Number of participants with clinically confirmed ARI will be reported.

Secondary Outcome Measures

Name	Time	Method
Number of Clinically Confirmed ARI Participants who Were Hospitalized	Up to 1 year 3 months	Number of clinically confirmed ARI participants who were hospitalized will be reported.
Number of Clinically Confirmed ARI Participants who Experienced Complications	Up to 1 year 3 months	Number of clinically confirmed ARI participants who experienced complications will be reported.
Number of Deaths in Clinically Confirmed ARI Participants	Up to 1 year 3 months	Number of deaths in clinically confirmed ARI participants will be reported.

Trial Locations

Locations (4)

Stanford Hospital and Clinics; 🇺🇸 Palo Alto, California, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Fred Hutchinson Research Center; 🇺🇸 Seattle, Washington, United States

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada