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NCT02534350

Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection

Completed Phase 2 Results posted Last updated 28 November 2018
What this trial tests

Phase 2 trial testing Presatovir in Respiratory Syncytial Virus (RSV) in 61 participants. Completed in 27 September 2017.

Timeline
31 December 2015
Primary endpoint
20 February 2017
27 September 2017

Quick facts

Lead sponsorGilead Sciences
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment61
Start date31 December 2015
Primary completion20 February 2017
Estimated completion27 September 2017
Sites28 locations across France, Netherlands, Belgium, United Kingdom, Germany, Canada, Australia, United States

Drugs / interventions tested

Conditions studied

Sponsor

Gilead Sciences — full company profile →

Who can join

18 and older, any sex, with Respiratory Syncytial Virus (RSV). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set Primary · Up to 7 days
GroupValue95% CI
Presatovir-0.73± 0.938
Placebo-0.90± 0.815
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 Primary · Up to 7 days
GroupValue95% CI
Presatovir-0.83± 1.013
Placebo-0.83± 0.757
Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7 Secondary · 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.

GroupValue95% CI
Presatovir-0.27± 0.313
Placebo-0.31± 0.298
Percent Change From Study Baseline in FEV1% Predicted Value Secondary · Baseline; Day 28

FEV1 is defined as forced expiratory volume in the first second.

GroupValue95% CI
Presatovir22.69± 27.437
Placebo26.36± 23.312

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Day 28. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Presatovir
Serious: 2/40 (5%)
Deaths: 0/40
Placebo
Serious: 4/20 (20%)
Deaths: 0/20

Serious adverse events (7 terms)

ReactionSystemPresatovirPlacebo
HypoxiaRespiratory, thoracic and mediastinal disorders
AnaemiaBlood and lymphatic system disorders
Non-cardiac chest painGeneral disorders
SepsisInfections and infestations
Mental status changesPsychiatric disorders
Deep vein thrombosisVascular disorders
HypotensionVascular disorders
Other adverse events (54 terms — click to expand)

ReactionSystemPresatovirPlacebo
NauseaGastrointestinal disorders
DizzinessNervous system disorders
HeadacheNervous system disorders
DiarrhoeaGastrointestinal disorders
FatigueGeneral disorders
CoughRespiratory, thoracic and mediastinal disorders
AnaemiaBlood and lymphatic system disorders
VomitingGastrointestinal disorders
LeukopeniaBlood and lymphatic system disorders
PalpitationsCardiac disorders
FlatulenceGastrointestinal disorders
Blood bicarbonate decreasedInvestigations
Forced expiratory volume decreasedInvestigations
Haemoglobin decreasedInvestigations
TremorNervous system disorders
InsomniaPsychiatric disorders
PollakiuriaRenal and urinary disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
Productive coughRespiratory, thoracic and mediastinal disorders
Sputum discolouredRespiratory, thoracic and mediastinal disorders
Lacrimation increasedEye disorders
Ocular hyperaemiaEye disorders
Vision blurredEye disorders
Visual impairmentEye disorders
Abdominal painGastrointestinal disorders
Abdominal pain upperGastrointestinal disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
GlossodyniaGastrointestinal disorders
Mouth ulcerationGastrointestinal disorders
Pneumatosis intestinalisGastrointestinal disorders
Non-cardiac chest painGeneral disorders
Candida infectionInfections and infestations
Nasal herpesInfections and infestations
Respiratory tract infectionInfections and infestations
Urinary tract infectionInfections and infestations
Chest X-ray abnormalInvestigations
Forced expiratory flow decreasedInvestigations
Transaminases increasedInvestigations
Decreased appetiteMetabolism and nutrition disorders
DehydrationMetabolism and nutrition disorders

Most-reported serious reactions: Hypoxia, Anaemia, Non-cardiac chest pain, Sepsis, Mental status changes, Deep vein thrombosis, Hypotension.

Data from ClinicalTrials.gov NCT02534350 adverse events section.

Sponsor's own description

The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Innovation and trends in the development and approval of antiviral medicines: 1987-2017 and beyond.
    Chaudhuri S, Symons JA, Deval J. · · 2018 · cited 136× · PMID 29758235 · DOI 10.1016/j.antiviral.2018.05.005
  2. Past, Present and Future Approaches to the Prevention and Treatment of Respiratory Syncytial Virus Infection in Children.
    Simões EAF, Bont L, Manzoni P, Fauroux B, et al · · 2018 · cited 116× · PMID 29470837 · DOI 10.1007/s40121-018-0188-z
  3. Overview of Current Therapeutics and Novel Candidates Against Influenza, Respiratory Syncytial Virus, and Middle East Respiratory Syndrome Coronavirus Infections.
    Behzadi MA, Leyva-Grado VH. · · 2019 · cited 78× · PMID 31275265 · DOI 10.3389/fmicb.2019.01327
  4. Respiratory Viral Infections in Solid Organ and Hematopoietic Stem Cell Transplantation.
    Paulsen GC, Danziger-Isakov L. · · 2017 · cited 49× · PMID 29128020 · DOI 10.1016/j.ccm.2017.07.012
  5. A randomized controlled trial of presatovir for respiratory syncytial virus after lung transplant.
    Gottlieb J, Torres F, Haddad T, Dhillon G, et al · · 2023 · cited 26× · PMID 36964084 · DOI 10.1016/j.healun.2023.01.013
  6. Assessment of Drug Resistance during Phase 2b Clinical Trials of Presatovir in Adults Naturally Infected with Respiratory Syncytial Virus.
    Porter DP, Guo Y, Perry J, Gossage DL, et al · · 2020 · cited 25× · PMID 32071058 · DOI 10.1128/aac.02312-19
  7. Structural Insight into Paramyxovirus and Pneumovirus Entry Inhibition.
    Aggarwal M, Plemper RK. · · 2020 · cited 15× · PMID 32245118 · DOI 10.3390/v12030342
  8. Non-nucleoside structured compounds with antiviral activity-past 10 years (2010-2020).
    Denel-Bobrowska M, Olejniczak AB. · · 2022 · cited 5× · PMID 35085926 · DOI 10.1016/j.ejmech.2022.114136

Verify or expand the search:

Other trials of Presatovir

Trials testing the same drug.

Other recruiting trials for Respiratory Syncytial Virus (RSV)

Currently open trials in the same condition.

Other Gilead Sciences trials

Trials by the same sponsor.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing