Trial · NCT02254408

Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

NCT02254408, Phase 2, Completed, Gilead Sciences; results first posted 2018-08-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract. Trials, record NCT02254408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02254408

On this page

Trial

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

Title: Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
NCT number: NCT02254408
Status: Completed
Phases: Phase 2
Enrollment: 189 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Respiratory Syncytial Virus
Interventions: Presatovir, Placebo
First posted: 2014-10-01
Last updated: 2018-08-06
Other registries' IDs: eudract:2014-002474-36
Results first posted: 2018-08-06

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9	Baseline; Day 9	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.
Primary	Percentage of Participants Who Developed a Lower Respiratory Tract Complication	Up to Day 28	A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee: * Primary RSV lower respiratory tract infection (LRTI) * Secondary bacterial LRTI * LRTI due to unusual pathogens * Lower respiratory tract complication of unknown etiology
Secondary	Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality	Up to Day 28	Participants were considered to have an event if either condition is met: * Participant develops a respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) or; * Participant dies prior to or on Day 28

Source ClinicalTrials.gov

Outcomes3

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 Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9	Baseline; Day 9	Full Analysis Set: participants who received at least 1 full dose of study drug and had an RSV viral load greater than or equal to the lower limit of quantification of the quantitative real-time polymerase chain reaction (RT-qPCR) assay in the Day 1 nasal sample, as determined by RT-qPCR.	log10 copies/mL	MEAN
PRIMARY	Percentage of Participants Who Developed a Lower Respiratory Tract Complication	Up to Day 28	Full Analysis Set	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality	Up to Day 28	Full Analysis Set	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group6

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 Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9	Presatovir	-1.26	Standard Deviation 0.964	log10 copies/mL
Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9	Placebo	-0.91	Standard Deviation 1.145	log10 copies/mL
Percentage of Participants Who Developed a Lower Respiratory Tract Complication	Presatovir	11.2	95% Confidence Interval 5.5 to 19.7	percentage of participants
Percentage of Participants Who Developed a Lower Respiratory Tract Complication	Placebo	19.5	95% Confidence Interval 11.8 to 29.4	percentage of participants
Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality	Presatovir	5.6	95% Confidence Interval 1.8 to 12.6	percentage of participants
Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality	Placebo	5.7	95% Confidence Interval 1.9 to 12.9	percentage of participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Presatovir	96
Overall Study	STARTED	Placebo	93
Overall Study	COMPLETED	Presatovir	88
Overall Study	COMPLETED	Placebo	83
Overall Study	NOT COMPLETED	Presatovir	8
Overall Study	NOT COMPLETED	Placebo	10

Source ClinicalTrials.gov

Adverse events110

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	Anaemia	Blood and lymphatic system disorders	Presatovir	5	95
other	Anaemia	Blood and lymphatic system disorders	Placebo	1	90
other	Febrile neutropenia	Blood and lymphatic system disorders	Presatovir	2	95
other	Febrile neutropenia	Blood and lymphatic system disorders	Placebo	5	90
other	Neutropenia	Blood and lymphatic system disorders	Presatovir	3	95
other	Neutropenia	Blood and lymphatic system disorders	Placebo	5	90
other	Diarrhoea	Gastrointestinal disorders	Presatovir	15	95
other	Diarrhoea	Gastrointestinal disorders	Placebo	14	90
other	Nausea	Gastrointestinal disorders	Presatovir	13	95
other	Nausea	Gastrointestinal disorders	Placebo	10	90

1 to 10 of 110Source ClinicalTrials.gov

See all 110 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Presatovir	2	95
Total, all-cause mortality	Placebo	4	90
Total, other adverse events	Presatovir	49	95
Total, other adverse events	Placebo	47	90
Total, serious adverse events	Presatovir	18	95
Total, serious adverse events	Placebo	23	90

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31793991	DERIVED

Source PubMed

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/NCT02254408

GET https://conductscience.org/api/trials/v1/NCT02254408/events?page=2

API reference For AI assistants