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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)

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Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
13 Years
Maximum Age
75 Years

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

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Study Stats
Protocol No.
19-001791
Category
Hematology-Oncology
Oncology
Contact
Drew Winston
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04056611
For detailed technical eligibility, visit ClinicalTrials.gov.