Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)

• Status: Recruiting
• Trial end date: 2025-08-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Sciences Ireland UC

Criteria

Inclusion Criteria:

• Received an autologous or allogeneic hematopoietic stem cell transplant (HSCT) using any conditioning regimen

• Absolute lymphocyte count (ALC) less than (<) 1,000 cells/microliter (mL)

• Participant has laboratory confirmed RSV diagnosis within 48 hours of randomization

• New onset of at least 1 of the following respiratory symptoms within 4 days prior to the anticipated start of dosing nasal congestion, rhinorrhea, cough or pharyngitis (sore throat), and/or worsening of one of these chronic (associated with previously existing diagnosis, example, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms within 4 days prior to the anticipated start of dosing

• Peripheral capillary oxygen saturation (SpO2) greater than or equal to (>=) 92 percent (%) on room air

Exclusion Criteria:

• Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator

• Requires supplemental oxygen at Screening or any time between Screening and randomization

• Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus) within 7 days prior to or at the Screening visit, if determined by local SOC testing (additional testing is not required)

• Clinically significant bacteremia or fungemia within 7 days prior to or at Screening that has not been adequately treated, as determined by the investigator