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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02254408
• Date of registration: 29/09/2014
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
• Scientific title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract
• Date of first enrolment: January 23, 2015
• Target sample size: 189
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02254408
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Brazil, Canada, France, Germany, Israel, Korea, Republic of, Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Gilead Study Director
• Affiliation: Gilead Sciences

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Syncytial Virus

Intervention(s)

Drug: Placebo

Drug: Presatovir

Primary Outcome(s)

Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9 [Time Frame: Baseline; Day 9]

Percentage of Participants Who Developed a Lower Respiratory Tract Complication [Time Frame: Up to Day 28]

Secondary Outcome(s)

Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality [Time Frame: Up to Day 28]

Secondary ID(s)

2014-002474-36

GS-US-218-0108

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02254408