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Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT02135614•Gilead Sciences

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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
+15 more criteria

Locations (43)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Anne Arundel Medical Center

Annapolis, Maryland, United States

Henry Ford Health System

Detroit, Michigan, United States

William Beaumont

Royal Oak, Michigan, United States

New York Presbyterian Hospital

New York, New York, United States

Rochester General Hospital

Rochester, New York, United States

Vanderbilt Medical Group and Clinic

Nashville, Tennessee, United States

University of Washington

Seattle, Washington, United States

Marshfield Clinic Research Foundation

Marshfield, Wisconsin, United States

John Hunter Hospital

New Lambton, New South Wales, Australia

Key Dates

Start Date

June 9, 2014

Primary Completion Date

March 27, 2017

Completion Date

April 12, 2017

Last Updated

September 24, 2018

Enrollment

189

ACTUAL participants

Conditions

Respiratory Syncytial Virus Infection

Interventions

Presatovir

DRUG

Presatovir placebo

DRUG

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

NCT07220109

Respiratory Syncytial Virus Infections

View study

RECRUITINGPHASE2

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

NCT07092865

Respiratory Syncytial Virus Infections

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older

Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children