Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection
NCT ID: NCT02135614
Last Updated: 2018-09-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
189 participants
INTERVENTIONAL
2014-06-09
2017-04-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Presatovir
Participants will receive a single dose of presatovir.
Presatovir
Presatovir 200 mg (4 x 50 mg tablets) administered orally
Presatovir placebo
Participants will receive a single dose of presatovir placebo.
Presatovir placebo
Presatovir placebo tablets administered orally
Interventions
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Presatovir
Presatovir 200 mg (4 x 50 mg tablets) administered orally
Presatovir placebo
Presatovir placebo tablets administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Related to medical condition at screening:
* Influenza-positive as determined by local diagnostic test
* Known Middle East Respiratory Syndrome coronavirus (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 adequately 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 study drug
* Related to allergies:
* Known allergy to components of the study drug (microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc)
* Documented history of acute (anaphylaxis) or delayed (Stevens-Johnson syndrome or epidermal necrolysis) allergy to sulfa drugs
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Study Protocol: Amendment 4
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-002137-58
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-218-1227
Identifier Type: -
Identifier Source: org_study_id
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