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



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:9/26/2018
Start Date:June 9, 2014
End Date:April 12, 2017

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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

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.


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.
We found this trial at
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Seattle, Washington 98104
(206) 543-2100
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New Lambton, New South Wales 2305
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Rochester, New York 14621
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