Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection
2 other identifiers
interventional
189
11 countries
43
Brief Summary
The primary objective of this study is to evaluate the effects of presatovir on respiratory syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute respiratory infectious symptoms. Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days postdose. Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change in viral load as the primary endpoint.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2014
Typical duration for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2014
CompletedFirst Posted
Study publicly available on registry
May 12, 2014
CompletedStudy Start
First participant enrolled
June 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2017
CompletedResults Posted
Study results publicly available
May 11, 2018
CompletedSeptember 24, 2018
May 1, 2018
2.8 years
May 8, 2014
March 27, 2018
August 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5
The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Baseline to Day 5
Secondary Outcomes (3)
Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5
Baseline to Day 5
Number of Hospitalization-Free Days Following Presatovir Administration
Up to Day 28
Rate of Unplanned Medical Encounters
Up to Day 28
Study Arms (2)
Presatovir
EXPERIMENTALParticipants will receive a single dose of presatovir.
Presatovir placebo
PLACEBO COMPARATORParticipants will receive a single dose of presatovir placebo.
Interventions
Presatovir 200 mg (4 x 50 mg tablets) administered orally
Eligibility Criteria
You may qualify if:
- 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
- Documented to be RSV-positive at the current admission within 72 hours of screening, or as evaluated at screening
You may not qualify if:
- Related to concomitant or previous medication use:
- Use of oral prednisone or other corticosteroid equivalent to:
- \> 20 mg/day for \> 14 days prior to screening is not permitted.
- \> 20 mg/day for ≤ 14 days, including corticosteroids received during current hospitalization (ie, bolus doses), is permitted.
- ≤ 20 mg/day, regardless of duration, is permitted.
- Individuals taking a moderate or strong cytochrome P450 enzyme (CYP) inducer including but not limited to rifampin, St John's Wort, carbamazepine, phenytoin, efavirenz, bosentan, etracirine, modafinil, and nafcillin within 2 weeks prior to the first dose of study drug
- Related to medical history:
- Pregnant, breastfeeding, or lactating females
- Individuals requiring \> 50% supplemental oxygen (while the individual is awake) at screening
- Individuals with a Clinical Frailty Scale (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
- Individuals with HIV/AIDS and a known CD4 count \< 200 cells/uL
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (43)
Northwestern Memorial Hospital
Chicago, Illinois, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
William Beaumont
Royal Oak, Michigan, United States
New York Presbyterian Hospital
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
Vanderbilt Medical Group and Clinic
Nashville, Tennessee, United States
University of Washington
Seattle, Washington, United States
Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
John Hunter Hospital
New Lambton, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Redcliffe Hospital
Redcliffe, Queensland, Australia
Gold Coast Hospital
Southport, Queensland, Australia
Monash Medical Center
Clayton, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Universite Liebre de Bruxelles - Hopital Erasme
Anderlecht, Belgium
Hopital Foch
Suresnes, Hauts-de-Seine, France
CHRU Brest - Hospital Cavale Blanche
Brest, France
Hopital d'Instructions des Armees Percy
Clamart, France
Hopital Louis Mourier
Colombes, France
Hopital Saint Louis - Service de Pneumologie
Paris, France
Hopital Tenon
Paris, France
Soroka Medical Center
Beersheba, Israel
Edith Wolfson Medical Center
Holon, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, Israel
Meir Medical Center
Kefar Sava, Israel
Western Galilee Hospital-Nahariya
Nahariya, Israel
The Nazareth Hospital
Nazareth, Israel
Rabin Medical Center
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Sourasky Medical Center
Tel Aviv, Israel
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
Gelre Ziekenhuizen
Zutphen, Netherlands
Tauranga Hospital
Tauranga, Bay of Plenty, New Zealand
Middlemore Hospital
Auckland, New Zealand
Waikato Hospital
Hamilton, New Zealand
Centrum Badan Klinicznych
Wroclaw, Poland
Soon Chun Hyang University Hospital
Bucheon-si, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Asan Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Southampton University Hospitals NHS Trust
Southampton, United Kingdom
Princess Royal Hospital
Telford, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2014
First Posted
May 12, 2014
Study Start
June 9, 2014
Primary Completion
March 27, 2017
Study Completion
April 12, 2017
Last Updated
September 24, 2018
Results First Posted
May 11, 2018
Record last verified: 2018-05