Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
Respiratory Syncytial Virus
About this trial
This is an interventional treatment trial for Respiratory Syncytial Virus focused on measuring Respiratory Syncytial Virus (RSV), Antiviral, Hematopoietic Cell Transplant (HCT), Upper respiratory tract infection
Eligibility Criteria
Inclusion Criteria:
- Received an autologous or allogeneic HCT using any conditioning regimen
- Documented to be RSV-positive as determined by local testing (eg, polymerase chain reaction, direct fluorescence antibody, respiratory viral panel assay, or culture) using an upper respiratory tract sample collected ≤ 6 days prior to Day 1
- New onset of at least 1 of the following respiratory symptoms for ≤ 7 days prior to Day 1: nasal congestion, runny nose, cough, or sore throat, or worsening of one of these chronic (associated with a previously existing diagnosis, eg, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms ≤ 7 days prior to Day 1
- No evidence of new abnormalities consistent with lower respiratory tract infection (LRTI) on a chest X-ray relative to the most recent chest X-ray, as determined by the local radiologist. If a chest X-ray is not available or was not obtained during standard care < 48 hours prior to screening, a chest X-ray must be obtained for screening
- O2 saturation ≥ 92% on room air
- An informed consent document signed and dated by the participant or a legal guardian of the participant and the investigator or his/her designee
- A negative urine or serum pregnancy test is required for female participants (unless surgically sterile or greater than two years post-menopausal)
- Male and female participants of childbearing potential must agree to contraceptive requirements as described in the study protocol
- Willingness to complete necessary study procedures and have available a working telephone or email
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
Sites / Locations
- Mayo Clinic Arizona
- City of Hope
- UCLA David Geffen School of Medicine
- Stanford University
- Emory University
- NorthSide Medical Center
- Northwestern University
- University of Chicago
- Loyola University
- John Hopkins
- Dana Farber Cancer Institute
- University of Massachusetts Memorial Cancer Center
- University of Michigan
- Wayne State University
- University of Minnesota
- Washington University
- Memorial Sloan Kettering
- New York Presbyterian Hospital Cornell Medical Center
- Duke University
- University Hospital Case Medical
- Oregon Health Sciences University
- Vanderbilt University Medical Center
- MD Anderson Cancer Center
- Texas Transplant Institute (SCRI)
- University of Utah
- Fred Hutchison Cancer Research Center
- Medical College of Wisconsin
- Westmead Hospital
- Royal Brisbane & Women's Hospital
- Royal Melbourne Hospital
- Hospital de Clínicas de Porto Alegre
- Hospital Israelita Albert Einstein
- Hospital Universitario USP
- Fundacao Faculdade Regional Medicina de Sao Jose do Rio Preto
- Fundação Antonio Prudente - Hospital do Câncer AC Camargo
- Hospital Santa Marcelina
- Instituto Brasileiro de Controle do Câncer-IBCC
- Hopital Maisonneuve-Rosemont
- Tom Baker Cancer Centre
- CHU de Bordeaux
- Hopital Saint-Louis, APHP
- Hopital Foch
- Institut Universitaire du Cancer Oncopole
- Universitatsklinikum Wurzburg
- Soroka Medical Center
- Rambam Medical Center
- Hadassah Medical Center
- Rabin Medical Center
- Chaim Sheba Medical Center
- Tel Aviv Sourasky Medical Center
- Asan Medical Center
- Samsung Medical Center
- Seoul National University Hospital
- Seoul Saint Mary's Hospital
- Severance Hospital, Yonsei University Health System
- VUmc cancer center
- Erasmus Medical Center (Rotterdam)
- Singapore General Hospital
- UMC National University Health System
- Hospital universitario Virgen del Rocio
- Karolinska Institutet
- University Clinic Basel
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- China Medical University Hospital
- National Taiwan University Hospital
- Chang Gung Medical Foundation-LinKou Branch
- Leeds Teaching Hospitals Trust
- King's College Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Presatovir
Placebo
Participants will receive presatovir on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56.
Participants will receive placebo on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56.