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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Respiratory Syncytial Virus Infection

Treatments: Drug: Presatovir placebo; Drug: Presatovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02135614

2014-002137-58 (EudraCT Number)

GS-US-218-1227

Details and patient eligibility

About

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.

Enrollment: 189 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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189 participants in 2 patient groups, including a placebo group

Presatovir

Experimental group

Description:

Participants will receive a single dose of presatovir.

Treatment:

Drug: Presatovir

Presatovir placebo

Placebo Comparator group

Description:

Participants will receive a single dose of presatovir placebo.

Treatment:

Drug: Presatovir placebo