A Phase 2 clinical trial investigating the anti-virus effects, kinetics and safety of GS-5806 in adults with RSV (Respiratory Syncytial Virus) infectio
- Conditions
- Respiratory Syncytial Virus (RSV) InfectionMedDRA version: 18.1 Level: LLT Classification code 10039247 Term: RSV infection System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-002137-58-GB
- Lead Sponsor
- Gilead Sciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 189
An informed consent document signed and dated by the subject or a legal guardian of the subject and Investigator or his/her designee
Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 5 of the protocol.
Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm donation while enrolled in the study and for at least 90 days after administration of the last dose of study medication.
All subjects must refrain from blood donation while enrolled in the study and for 30 days after the last dose of IMP.
= 18 years of age at Screening
Willing to adhere to protocol specific requirements for contraception
Subject is a current inpatient
New onset of acute respiratory infectious symptoms, or acute worsening of chronic symptoms related to ongoing respiratory disease for = 5 days prior to screening:
Upper respiratory tract symptoms: Nasal congestion, runny nose, sore throat, or earache
Lower respiratory tract symptoms: Cough, sputum production, wheezing, dyspnea, or chest tightness
Willingness to perform necessary study procedures and have available a working telephone or email
Documented to be RSV-positive as per protocol Section 6.1.1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
Related to concomitant or previous medication use:
- Use of any investigational medicinal product in the 28 days prior to screening, OR use of any investigational monoclonal antibody within 4 months or 5 half-lives of screening, whichever is longer, OR use of any investigational RSV vaccine ever
- Chronic use (> 28 days of use) of systemic immunosuppressive agents (i.e. alkylating agents, calcineurin inhibitors, immunophilin-binding but not a calcineurin inhibitor, antimetabolites, polyclonal antibodies, monoclonal antibodies) during the 28 days prior to Screening, or anticipated use during the 28 days following Screening
-Use of oral prednisone or other corticosteroid equivalent to:
- > 20 mg/day > 14 days prior to screening is not permitted.
- > 20 mg/day = 14 days, including corticosteroids received during current hospitalisation (ie bolus doses) is permitted.
- = 20 mg/day, regardless of duration is permitted.
- Subjects taking a moderate or strong cytochrome P450 (CYP) enzyme inducer including but not limited to rifampin, St John’s wort, carbamazepine, and phenytoin, efavirenz, bosentan, etravirine, modafinil, and nafcillin within 2 weeks prior to the first dose of IMP
Related to medical history:
-Pregnant, breastfeeding, or lactating females
-Subjects requiring > 50% supplemental oxygen (while the subject is awake) at Screening
- Subjects with a CFS > 7 at Baseline
-Known significant abnormality altering the anatomy of the nose or nasopharynx that in, the opinion of the investigator, will preclude obtaining adequate nasal swab sampling in either nasal passage
-Waiting for or recently (within the past 12 months) received a bone marrow, stem cell, or solid organ transplant, or who have received radiation or chemotherapy within 12 months prior to screening
- Subjects with HIV/AIDS and a known CD4 count < 200 cells / µl
-History of severe dementia or Alzheimer’s disease
- History of drug and/or alcohol abuse that, in the opinion of the investigator, may prevent adherence to study activities
Related to medical condition:
- Influenza-positive as determined by local diagnostic test
- Known MERS-CoV infection or known coinfection with other coronavirus
-Use of mechanical ventilation during the current admission, not including noninvasive ventilation
- Clinically significant bacteremia or fungemia that has not been adequatly treated prior to screening, as determined by the investigator
- Inadequate treatment of confirmed bacterial, fungal, or non-RSV pneumonia, as determined by the investigator
- Excessive nausea/vomiting at admission, as determined by the investigator, that precludes administration of an orally administered IMP
-Subjects with an unstable medical condition, as determined by the investigator, that preclude participation in the study
Related to allergies:
- Known allergy to components of the IMP (microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc).
- Documented history of acute (anaphyl
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the effects of presatovir(GS-5806) on RSV viral load in RSV-positive adults hospitalized with acute respiratory infectious symptoms.;<br> Secondary Objective: The effect of presatovir on change in the FLU-PRO score from Baseline<br> The effect of presatovir on the length of hospital stay<br> The effect of presatovir on the rate of unplanned healthcare<br> encounters (clinic visits, emergency room visits, urgent care<br> visits, and rehospitalizations) related to a respiratory illness<br> after discharge<br> The pharmacokinetics (PK), safety, and tolerability of presatovir<br> ;Primary end point(s): The time-weighted average change in log10 viral load from Baseline (Day 1) to Day 5.;Timepoint(s) of evaluation of this end point: Day 1 and 5
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): -Time-weighted average change in the FLU-PRO score from Baseline (Day 1) to Day 5<br> - Duration of hospital stay following IMP administration<br> - Rate of unplanned medical encounters (clinic visits, emergency room visits, urgent care visits, and rehospitalizations) related to a respiratory illness after initial hospital discharge through Day 28<br> ;Timepoint(s) of evaluation of this end point: Day 5 and day 28.