Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Received an autologous or allogeneic HCT using any conditioning regimen
Evidence of new abnormalities on chest X-ray obtained \< 48 hours prior to screening, determined to be consistent with LRTI by the local radiologist, relative to the most recent previous chest X-ray. If chest X-ray is not available, a chest X-ray must be obtained for screening.
Documented RSV in both the upper (eg, nasal swab, nasopharyngeal swab, nasal wash) and lower (eg, induced sputum, bronchoalveolar lavage, lung biopsy, but not spontaneous sputum) respiratory tract as determined by local testing (eg, polymerase chain reaction, direct fluorescence antibody, respiratory viral panel assay, or culture). All samples must have been collected ≤ 6 days prior to Day 1, or as determined at screening as per protocol.
An informed consent document signed and dated by the participant or a legal guardian of the participant and 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
You may not be if
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
Use of a moderate or strong cytochrome P450 enzyme inducer including but not limited to rifampin, St. John's Wort, carbamazepine, phenytoin, efavirenz, bosentan, etravirine, modafinil, and nafcillin, within 2 weeks prior to the first dose of study drug
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 conditions:
Requiring invasive mechanical ventilation at the time of randomization
Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus), from the lower respiratory tract sample as determined by local testing
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 individuals without an NG 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
Clareo Health | Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract
