Trial · NCT02135614

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

NCT02135614, Phase 2, Completed, Gilead Sciences; results first posted 2018-05-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection. Trials, record NCT02135614. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02135614

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection
NCT number: NCT02135614
Status: Completed
Phases: Phase 2
Enrollment: 189 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Respiratory Syncytial Virus Infection
Interventions: Presatovir, Presatovir placebo
First posted: 2014-05-12
Last updated: 2018-09-24
Other registries' IDs: eudract:2014-002137-58
Results first posted: 2018-05-11

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	Number of Hospitalization-Free Days Following Presatovir Administration	Up to Day 28
Secondary	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5	Baseline to Day 5	Evaluable Analysis Set: all randomized participants who received at least 1 dose of study medication, had an RSV viral load greater than lower limit of quantification (LLOQ) of the RT-qPCR assay in the Day 1 nasal-swab sample, and had a minimum of 3 quantifiable samples (including baseline) within a 5 day period.	log10 copies/mL	MEAN
SECONDARY	Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5	Baseline to Day 5	Participants in the Evaluable Analysis Set with available data were analyzed.	units on a scale	MEAN
SECONDARY	Number of Hospitalization-Free Days Following Presatovir Administration	Up to Day 28	Evaluable Analysis Set: all randomized participants who received at least 1 dose of study medication, had an RSV viral load greater than lower limit of quantification (LLOQ) of the RT-qPCR assay in the Day 1 nasal-swab sample, and had a minimum of 3 quantifiable samples (including baseline) within a 5 day period.	days	MEDIAN
SECONDARY	Rate of Unplanned Medical Encounters	Up to Day 28	Evaluable Analysis Set: all randomized participants who received at least 1 dose of study medication, had an RSV viral load greater than lower limit of quantification (LLOQ) of the RT-qPCR assay in the Day 1 nasal-swab sample, and had a minimum of 3 quantifiable samples (including baseline) within a 5 day period.	encounters per participant	NUMBER

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5	Presatovir	-0.77	Standard Error 0.113	log10 copies/mL
Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5	Placebo	-0.89	Standard Error 0.118	log10 copies/mL
Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5	Presatovir	-0.27	Standard Error 0.029	units on a scale
Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5	Placebo	-0.35	Standard Error 0.030	units on a scale
Number of Hospitalization-Free Days Following Presatovir Administration	Presatovir	25	Inter-Quartile Range 20 to 27	days
Number of Hospitalization-Free Days Following Presatovir Administration	Placebo	25	Inter-Quartile Range 20 to 27	days
Rate of Unplanned Medical Encounters	Presatovir	0.226	95% Confidence Interval 0.133 to 0.384	encounters per participant
Rate of Unplanned Medical Encounters	Placebo	0.066	95% Confidence Interval 0.029 to 0.150	encounters per participant

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Presatovir	94
Overall Study	STARTED	Placebo	95
Overall Study	COMPLETED	Presatovir	86
Overall Study	COMPLETED	Placebo	90
Overall Study	NOT COMPLETED	Presatovir	8
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events62

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	Presatovir	5	92
other	Abdominal pain	Gastrointestinal disorders	Placebo	2	94
other	Constipation	Gastrointestinal disorders	Presatovir	4	92
other	Constipation	Gastrointestinal disorders	Placebo	5	94
other	Diarrhoea	Gastrointestinal disorders	Presatovir	5	92
other	Diarrhoea	Gastrointestinal disorders	Placebo	7	94
other	Nausea	Gastrointestinal disorders	Presatovir	4	92
other	Nausea	Gastrointestinal disorders	Placebo	9	94
other	Vomiting	Gastrointestinal disorders	Presatovir	2	92
other	Vomiting	Gastrointestinal disorders	Placebo	6	94

1 to 10 of 62Source ClinicalTrials.gov

See all 62 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Presatovir	2	92
Total, all-cause mortality	Placebo	0	94
Total, other adverse events	Presatovir	34	92
Total, other adverse events	Placebo	31	94
Total, serious adverse events	Presatovir	8	92
Total, serious adverse events	Placebo	13	94

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Presatovir vs Placebo: deaths from any cause	Trial comparisons
Presatovir vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02135614

GET https://conductscience.org/api/trials/v1/NCT02135614/events?page=2

API reference For AI assistants