NCT02254421

Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

Completed Phase 2 Results posted Last updated 24 September 2018

What this trial tests

Phase 2 trial testing Presatovir in Respiratory Syncytial Virus Infection in 60 participants. Completed in 17 April 2017.

Timeline

31 January 2015

Primary endpoint
17 April 2017

17 April 2017

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	31 January 2015
Primary completion	17 April 2017
Estimated completion	17 April 2017
Sites	17 locations across France, Sweden, South Korea, Switzerland, United States

Drugs / interventions tested

• Presatovir — full drug profile →
• Placebo

Conditions studied

• Respiratory Syncytial Virus Infection — all drugs for Respiratory Syncytial Virus Infection →

Sponsor

Gilead Sciences — full company profile →

Who can join

Adults 18 to 75, any sex, with Respiratory Syncytial Virus Infection. 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 Nasal Respiratory Syncytial Viral (RSV) Load From Baseline to Day 9 Primary · Baseline to 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 factors.

Group	Value	95% CI
Presatovir	-1.00	± 0.215
Placebo	-0.97	± 0.218

Number of Supplemental O2-Free Days Through Day 28 Secondary · Up to Day 28

Group	Value	95% CI
Presatovir	26	10 – 28
Placebo	28	9 – 28

Percentage of Participants Developing Respiratory Failure Requiring Mechanical Ventilation Through Day 28 Secondary · Up to Day 28

Group	Value	95% CI
Presatovir	10.3	2.2 – 27.4
Placebo	10.7	2.3 – 28.2

Percentage of All-Cause Mortality Among Participants Through Day 28 Secondary · Up to Day 28

Group	Value	95% CI
Presatovir	0.0	0.0 – 11.9
Placebo	7.1	0.9 – 23.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 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: 7/30 (23%)

Deaths: 0/30

Placebo

Serious: 7/29 (24%)

Deaths: 4/29

Serious adverse events (16 terms)

Reaction	System	Presatovir	Placebo
Pneumonia	Infections and infestations	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Graft versus host disease	Immune system disorders	—	—
Bacterial infection	Infections and infestations	—	—
Clostridium difficile colitis	Infections and infestations	—	—
Febrile infection	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Altered state of consciousness	Nervous system disorders	—	—
Cerebral infarction	Nervous system disorders	—	—
Cerebrovascular accident	Nervous system disorders	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Hypotension	Vascular disorders	—	—

Other adverse events (29 terms — click to expand)

Reaction	System	Presatovir	Placebo
Anaemia	Blood and lymphatic system disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Acute sinusitis	Infections and infestations	—	—
Alanine aminotransferase increased	Investigations	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Headache	Nervous system disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Visual impairment	Eye disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Non-cardiac chest pain	General disorders	—	—
Oedema peripheral	General disorders	—	—
Aspartate aminotransferase increased	Investigations	—	—
Blood alkaline phosphatase increased	Investigations	—	—
Troponin T increased	Investigations	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Anxiety	Psychiatric disorders	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Hypotension	Vascular disorders	—	—

Most-reported serious reactions: Pneumonia, Respiratory failure, Anaemia, Febrile neutropenia, Graft versus host disease, Bacterial infection, Clostridium difficile colitis, Febrile infection.

Data from ClinicalTrials.gov NCT02254421 adverse events section.

Sponsor's own description

The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).

Publications & conference data

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

1. 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
2. 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
3. Respiratory syncytial virus: from pathogenesis to potential therapeutic strategies.
   Shang Z, Tan S, Ma D. · · 2021 · cited 74× · PMID 34671221 · DOI 10.7150/ijbs.64762
4. A Phase 2b, Randomized, Double-blind, Placebo-Controlled Multicenter Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of Presatovir in Hematopoietic Cell Transplant Recipients with Respiratory Syncytial Virus Infection of the Lower Respiratory Tract.
   Marty FM, Chemaly RF, Mullane KM, Lee DG, et al · · 2020 · cited 60× · PMID 31915807 · DOI 10.1093/cid/ciz1167
5. GS-5806 Inhibits a Broad Range of Respiratory Syncytial Virus Clinical Isolates by Blocking the Virus-Cell Fusion Process.
   Perron M, Stray K, Kinkade A, Theodore D, et al · · 2015 · cited 58× · PMID 26666922 · DOI 10.1128/aac.01497-15
6. 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
7. Epidemiology and outcomes of hospitalized adults with respiratory syncytial virus: A 6-year retrospective study.
   Schmidt H, Das A, Nam H, Yang A, et al · · 2019 · cited 35× · PMID 30977284 · DOI 10.1111/irv.12643
8. Cotton rat model for testing vaccines and antivirals against respiratory syncytial virus.
   Boukhvalova MS, Yim KC, Blanco J. · · 2018 · cited 28× · PMID 29768937 · DOI 10.1177/2040206618770518