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

NCT05661604 | Completed

• 2 other identifiers: CR109291NOPRODVIR0001
• Study Type: observational
• Target: 140
• Locations: 2 countries
• Sites: 4

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.

Conditions

Acute Respiratory Viral Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of Clinically Confirmed ARI Participants who Were Hospitalized

  Up to 1 year 3 months

• Number of Clinically Confirmed ARI Participants who Experienced Complications

  Up to 1 year 3 months

• Number of Deaths in Clinically Confirmed ARI Participants

  Up to 1 year 3 months

Study Arms (1)

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

Interventions

No Intervention OTHER

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.

Participants at High Risk for Poor Outcomes From a Respiratory Infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (4)

Stanford Hospital and Clinics

Palo Alto, California, 94305, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Fred Hutchinson Research Center

Seattle, Washington, 98109, United States

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L8E7, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, whole blood and nasosorption samples will be collected to retain DNA if required.

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 22, 2022
• Study Start: January 19, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CA (1)