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Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02135614
First Posted: May 12, 2014
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose

This study is to evaluate the antiviral effect, pharmacokinetics, safety, and tolerability of presatovir in respiratory syncytial virus (RSV) positive adults who have been hospitalized with acute respiratory infectious symptoms.

Participants will receive 1 dose of presatovir and followed for 28 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.


Condition Intervention Phase
Respiratory Syncytial Virus (RSV) Infections Drug: Presatovir Drug: Presatovir placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Time-weighted average change in respiratory syncytial viral load [ Time Frame: Day 1 to Day 5 ]
    The time-weighted average change in log10 viral load from Day 1 to Day 5 will be assessed.


Secondary Outcome Measures:
  • Time-weighted average change in the FLU-PRO score [ Time Frame: Day 1 to Day 5 ]
    The FLU-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza.

  • Duration of hospital stay following presatovir administration [ Time Frame: Up to 28 days ]
  • Rate of unplanned medical encounters [ Time Frame: Up to 28 days ]
    The 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 will be assessed.


Enrollment: 190
Actual Study Start Date: June 9, 2014
Study Completion Date: April 12, 2017
Primary Completion Date: March 27, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Presatovir
Participants will receive a single dose of presatovir.
Drug: Presatovir
Presatovir 200 mg (4 x 50 mg tablets) administered orally
Other Name: GS-5806
Placebo Comparator: Presatovir placebo
Participants will receive a single dose of presatovir placebo.
Drug: Presatovir placebo
Presatovir placebo tablets administered orally

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135614


  Show 43 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02135614     History of Changes
Other Study ID Numbers: GS-US-218-1227
2014-002137-58 ( EudraCT Number )
First Submitted: May 8, 2014
First Posted: May 12, 2014
Last Update Posted: November 17, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases