Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

Exclusion Criteria

• •Related to concomitant or previous medication use:
• •Use of non-marketed (according to region) investigational agents within 30 days, OR use of any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of screening, whichever is longer, OR use of any investigational RSV vaccines after HCT
• •Related to medical history:
• •Pregnant, breastfeeding, or lactating females
• •Unable to tolerate nasal sampling required for this study, as determined by the investigator
• •Known history of HIV/AIDS with a CD4 count \<200 cells/μL within the last month
• •History of drug and/or alcohol abuse that, in the opinion of the investigator, may prevent adherence to study activities
• •Related to medical condition at screening:
• •Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, or human metapneumovirus, or coronavirus) within 7 days prior to the screening visit, as determined by local testing (additional testing is not required)
• •Clinically significant bacteremia or fungemia within 7 days prior to screening that has not been adequately treated, as determined by the investigator
• •Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to screening that has not been adequately treated, as determined by the investigator
• •Excessive nausea/vomiting at screening, as determined by the investigator, or an inability to swallow pills that precludes oral administration of the investigational medical product (for participants without an nasogastric tube in place)
• •Any condition which, in the opinion of the investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints
• •Related to laboratory results:
• •Creatinine clearance \< 30 mL/min (calculated using the Cockcroft-Gault method)
• •Clinically significant aspartate aminotransferase/alanine aminotransferase, as determined by the investigator
• •Clinically significant total bilirubin, as determined by the investigator