Clinical trial NCT02135614: Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-05-12
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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
* 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5
timeFrame: Baseline to Day 5
Secondary outcomes:
measure: Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5
timeFrame: Baseline to Day 5
measure: Number of Hospitalization-Free Days Following Presatovir Administration
timeFrame: Up to Day 28
measure: Rate of Unplanned Medical Encounters
timeFrame: Up to Day 28
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont
state: Michigan
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Nashville
country: United States
facility: Vanderbilt Medical Group and Clinic
state: Tennessee
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic Research Foundation
state: Wisconsin
city: New Lambton
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Redcliffe
country: Australia
facility: Redcliffe Hospital
state: Queensland
city: Southport
country: Australia
facility: Gold Coast Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash Medical Center
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Anderlecht
country: Belgium
facility: Universite Liebre de Bruxelles - Hopital Erasme
city: Suresnes
country: France
facility: Hopital Foch
state: Hauts-de-Seine
city: Brest
country: France
facility: CHRU Brest - Hospital Cavale Blanche
city: Clamart
country: France
facility: Hopital d'Instructions des Armees Percy
city: Colombes
country: France
facility: Hopital Louis Mourier
city: Paris
country: France
facility: Hopital Saint Louis - Service de Pneumologie
city: Paris
country: France
facility: Hopital Tenon
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Ein Kerem
city: Kefar-Sava
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: Western Galilee Hospital-Nahariya
city: Nazareth
country: Israel
facility: The Nazareth Hospital
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Zutphen
country: Netherlands
facility: Gelre Ziekenhuizen
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
state: Bay Of Plenty
city: Auckland
country: New Zealand
facility: Middlemore Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych
city: Southampton
country: United Kingdom
facility: Southampton University Hospitals NHS Trust
city: Telford
country: United Kingdom
facility: Princess Royal Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: