| Group | Value | 95% CI |
|---|---|---|
| Presatovir | -0.73 | ± 0.938 |
| Placebo | -0.90 | ± 0.815 |
Last reviewed · How we verify
NCT02534350
Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection
Phase 2 trial testing Presatovir in Respiratory Syncytial Virus (RSV) in 61 participants. Completed in 27 September 2017.
20 February 2017
Quick facts
| Lead sponsor | Gilead Sciences |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 61 |
| Start date | 31 December 2015 |
| Primary completion | 20 February 2017 |
| Estimated completion | 27 September 2017 |
| Sites | 28 locations across France, Netherlands, Belgium, United Kingdom, Germany, Canada, Australia, United States |
Drugs / interventions tested
- Presatovir — full drug profile →
- Placebo
Conditions studied
- Respiratory Syncytial Virus (RSV) — all drugs for Respiratory Syncytial Virus (RSV) →
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.
| Group | Value | 95% CI |
|---|---|---|
| Presatovir | -0.83 | ± 1.013 |
| Placebo | -0.83 | ± 0.757 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Presatovir | -0.27 | ± 0.313 |
| Placebo | -0.31 | ± 0.298 |
FEV1 is defined as forced expiratory volume in the first second.
| Group | Value | 95% CI |
|---|---|---|
| Presatovir | 22.69 | ± 27.437 |
| Placebo | 26.36 | ± 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.
Serious adverse events (7 terms)
| Reaction | System | Presatovir | Placebo |
|---|---|---|---|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Non-cardiac chest pain | General disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Mental status changes | Psychiatric disorders | — | — |
| Deep vein thrombosis | Vascular disorders | — | — |
| Hypotension | Vascular disorders | — | — |
Other adverse events (54 terms — click to expand)
| Reaction | System | Presatovir | Placebo |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Palpitations | Cardiac disorders | — | — |
| Flatulence | Gastrointestinal disorders | — | — |
| Blood bicarbonate decreased | Investigations | — | — |
| Forced expiratory volume decreased | Investigations | — | — |
| Haemoglobin decreased | Investigations | — | — |
| Tremor | Nervous system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Pollakiuria | Renal and urinary disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | — | — |
| Lacrimation increased | Eye disorders | — | — |
| Ocular hyperaemia | Eye disorders | — | — |
| Vision blurred | Eye disorders | — | — |
| Visual impairment | Eye disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — |
| Glossodynia | Gastrointestinal disorders | — | — |
| Mouth ulceration | Gastrointestinal disorders | — | — |
| Pneumatosis intestinalis | Gastrointestinal disorders | — | — |
| Non-cardiac chest pain | General disorders | — | — |
| Candida infection | Infections and infestations | — | — |
| Nasal herpes | Infections and infestations | — | — |
| Respiratory tract infection | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Chest X-ray abnormal | Investigations | — | — |
| Forced expiratory flow decreased | Investigations | — | — |
| Transaminases increased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Dehydration | Metabolism 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):
-
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 -
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 -
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 -
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 -
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 -
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 -
Structural Insight into Paramyxovirus and Pneumovirus Entry Inhibition.
Aggarwal M, Plemper RK. · · 2020 · cited 15× · PMID 32245118 · DOI 10.3390/v12030342 -
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:
- PubMed search for NCT02534350
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Presatovir
Trials testing the same drug.
- NCT02254421 — Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Res · Phase 2 · completed
- NCT02254408 — Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respirato · Phase 2 · completed
- NCT02135614 — Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infec · Phase 2 · completed
Other recruiting trials for Respiratory Syncytial Virus (RSV)
Currently open trials in the same condition.
- NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
- NCT06851806 — Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease · NA · recruiting
- NCT07249320 — Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants · active not recruiting
- NCT07272434 — Phase III Clinical Trial of the Recombinant Respiratory Syncytial Virus Vaccine ( CHO Cell) · Phase 3 · recruiting
- NCT07106918 — A Clinical Trial of SIBP-A16 Injection in Healthy Adults · EARLY_PHASE1 · recruiting
Other Gilead Sciences trials
Trials by the same sponsor.
- NCT07115368 — Study of GS-1219 in Participants With HIV-1 · Phase 1 · terminated
- NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
- NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain · completed
- NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated · Phase 2, PHASE3 · terminated
- NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02534350 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
- Last refreshed: 28 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02534350.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing