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

Phase 2

Completed

• Conditions: Respiratory Syncytial Virus Infection
• Interventions: Drug: Presatovir placebo; Drug: Presatovir

• Registration Number: NCT02135614
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-12
• Study Start: 2014-06-09
• Primary Completion: 2017-03-27
• Study Completion: 2017-04-12
• Disposition First Submitted: 2017-11-15
• Disposition First Submitted QC: 2017-11-15
• Disposition First Posted: 2017-11-17
• Results First Submitted: 2018-03-27
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-10
• Results First Posted: 2018-05-11
• Last Update Submitted: 2018-08-24
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Presatovir placebo	Presatovir placebo	Participants will receive a single dose of presatovir placebo.
Presatovir	Presatovir	Participants will receive a single dose of presatovir.

Primary Outcome Measures

Name	Time	Method
Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5	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.

Secondary Outcome Measures

Name	Time	Method
Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5	Baseline to Day 5	The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms). The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Number of Hospitalization-Free Days Following Presatovir Administration	Up to Day 28
Rate of Unplanned Medical Encounters	Up to Day 28	The adjusted 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. Event rate was calculated as the total number of unplanned medical encounters divided by the total number of participants. The mean values presented were adjusted for stratification factor.

Trial Locations

Locations (43)

William Beaumont; 🇺🇸 Royal Oak, Michigan, United States

Marshfield Clinic Research Foundation; 🇺🇸 Marshfield, Wisconsin, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Rochester General Hospital; 🇺🇸 Rochester, New York, United States

Hopital Foch; 🇫🇷 Suresnes, Hauts-de-Seine, France

Anne Arundel Medical Center; 🇺🇸 Annapolis, Maryland, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Redcliffe Hospital; 🇦🇺 Redcliffe, Queensland, Australia

Gold Coast Hospital; 🇦🇺 Southport, Queensland, Australia

Hopital d'Instructions des Armees Percy; 🇫🇷 Clamart, France

Hopital Louis Mourier; 🇫🇷 Colombes, France

Frankston Hospital; 🇦🇺 Frankston, Victoria, Australia

Universite Liebre de Bruxelles - Hopital Erasme; 🇧🇪 Anderlecht, Belgium

CHRU Brest - Hospital Cavale Blanche; 🇫🇷 Brest, France

Meir Medical Center; 🇮🇱 Kefar-Sava, Israel

Edith Wolfson Medical Center; 🇮🇱 Holon, Israel

Hadassah University Hospital Ein Kerem; 🇮🇱 Jerusalem, Israel

Western Galilee Hospital-Nahariya; 🇮🇱 Nahariya, Israel

Hopital Saint Louis - Service de Pneumologie; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France

Soroka Medical Center; 🇮🇱 Beer Sheva, Israel

Chaim Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

The Nazareth Hospital; 🇮🇱 Nazareth, Israel

Gelre Ziekenhuizen; 🇳🇱 Zutphen, Netherlands

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Tauranga Hospital; 🇳🇿 Tauranga, Bay Of Plenty, New Zealand

Gachon University Gil Hospital; 🇰🇷 Incheon, Korea, Republic of

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Middlemore Hospital; 🇳🇿 Auckland, New Zealand

Waikato Hospital; 🇳🇿 Hamilton, New Zealand

Centrum Badan Klinicznych; 🇵🇱 Wroclaw, Poland

Southampton University Hospitals NHS Trust; 🇬🇧 Southampton, United Kingdom

Princess Royal Hospital; 🇬🇧 Telford, United Kingdom

Vanderbilt Medical Group and Clinic; 🇺🇸 Nashville, Tennessee, United States

Monash Medical Center; 🇦🇺 Clayton, Victoria, Australia

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

John Hunter Hospital; 🇦🇺 New Lambton, New South Wales, Australia

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Soon Chun Hyang University Hospital; 🇰🇷 Bucheon, Korea, Republic of