Trial · NCT02534350
Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection
NCT02534350, Phase 2, Completed, Gilead Sciences; results first posted 2018-11-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection. Trials, record NCT02534350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02534350
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection
- NCT number
- NCT02534350
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Respiratory Syncytial Virus (RSV)
- Interventions
- Presatovir, Placebo
- First posted
- 2015-08-27
- Last updated
- 2018-11-28
- Other registries' IDs
- eudract:2015-002287-16
- Results first posted
- 2018-11-28
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 Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set | Up to 7 days | |
| Primary | Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median | Up to 7 days | |
| Secondary | Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7 | Up to 7 days | 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) for the 5-point severity scale and 0 (never) to 4 or more times (always) for the 5-point frequency scale. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor. |
| Secondary | Percent Change From Study Baseline in FEV1% Predicted Value | Baseline; Day 28 | FEV1 is defined as forced expiratory volume in the first second. |
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 Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set | Up to 7 days | Participants in the Full Analysis Set (participants who received at least 1 full dose of study drug and had an RSV viral load ≥ lower limit of quantification (LLOQ) of the real-time quantitative polymerase chain reaction (RT-qPCR) assay in the Day 1 nasal sample, as determined by RT-qPCR at the central lab) with available data were analyzed . | log10 copies/mL | MEAN |
| PRIMARY | Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median | Up to 7 days | Participants in the Full Analysis Set with available data were analyzed. | log10 copies/mL | MEAN |
| SECONDARY | Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7 | Up to 7 days | Participants in the Full Analysis Set with available data were analyzed. | units on a scale | MEAN |
| SECONDARY | Percent Change From Study Baseline in FEV1% Predicted Value | Baseline; Day 28 | Participants in the Full Analysis Set with available data were analyzed. | percent change | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set | Presatovir | -0.73 | Standard Deviation 0.938 | log10 copies/mL | |
| Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set | Placebo | -0.90 | Standard Deviation 0.815 | log10 copies/mL | |
Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median | Presatovir | -0.83 | Standard Deviation 1.013 | log10 copies/mL | |
Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median | Placebo | -0.83 | Standard Deviation 0.757 | log10 copies/mL | |
| Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7 | Presatovir | -0.27 | Standard Deviation 0.313 | units on a scale | |
| Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7 | Placebo | -0.31 | Standard Deviation 0.298 | units on a scale | |
| Percent Change From Study Baseline in FEV1% Predicted Value | Presatovir | 22.69 | Standard Deviation 27.437 | percent change | |
| Percent Change From Study Baseline in FEV1% Predicted Value | Placebo | 26.36 | Standard Deviation 23.312 | percent change |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Presatovir | 41 | |
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | COMPLETED | Presatovir | 37 | |
| Overall Study | COMPLETED | Placebo | 20 | |
| Overall Study | NOT COMPLETED | Presatovir | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events122
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 | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Presatovir | 2 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 3 | 20 | |
| other | Leukopenia | Blood and lymphatic system disorders | Presatovir | 2 | 40 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 0 | 20 | |
| other | Palpitations | Cardiac disorders | Presatovir | 2 | 40 | |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 20 | |
| other | Lacrimation increased | Eye disorders | Presatovir | 0 | 40 | |
| other | Lacrimation increased | Eye disorders | Placebo | 1 | 20 | |
| other | Ocular hyperaemia | Eye disorders | Presatovir | 0 | 40 | |
| other | Ocular hyperaemia | Eye disorders | Placebo | 1 | 20 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Presatovir | 0 | 40 |
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, other adverse events | Presatovir | 24 | 40 |
| Total, other adverse events | Placebo | 17 | 20 |
| Total, serious adverse events | Presatovir | 2 | 40 |
| Total, serious adverse events | Placebo | 4 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36964084 | 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.
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/NCT02534350
GET https://conductscience.org/api/trials/v1/NCT02534350/events?page=2