Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection
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|ClinicalTrials.gov Identifier: NCT02135614|
Recruitment Status : Completed
First Posted : May 12, 2014
Results First Posted : May 11, 2018
Last Update Posted : September 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Syncytial Virus Infection||Drug: Presatovir Drug: Presatovir placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||189 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||June 9, 2014|
|Actual Primary Completion Date :||March 27, 2017|
|Actual Study Completion Date :||April 12, 2017|
Participants will receive a single dose of 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
- Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5 [ Time Frame: 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.
- Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5 [ Time Frame: 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 [ Time Frame: Up to Day 28 ]
- Rate of Unplanned Medical Encounters [ Time Frame: 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.
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
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|Study Director:||Gilead Study Director||Gilead Sciences|