Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020
A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial of Presatovir for the Treatment of Respiratory Syncytial Virus Upper Respiratory Tract Infection in Hematopoietic-Cell Transplant Recipients.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02254408 (A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant), which is not on this map. Cited by 30 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract
Who cites it
30 citing papers in PubMed, 72 citations in OpenAlex.
- 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.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020Trial
- Assessment of Drug Resistance during Phase 2b Clinical Trials of Presatovir in Adults Naturally Infected with Respiratory Syncytial Virus.Antimicrobial agents and chemotherapy · 2020Trial
- Utilizing Virtual Clinical Trials to Inform Target Coverage That Drives RSV Antiviral Efficacy.CPT: pharmacometrics & systems pharmacology · 2026Article
- STAT1 signaling controls cholesterol metabolism in epithelial cells and RSV-induced syncytia formation.Npj viruses · 2026Article
- Review
- Review
- Respiratory syncytial virus: health burden, disease prevention, and treatment-recent progress and lessons learned.microLife · 2025Review
- Vaccine and therapeutic agents against the respiratory syncytial virus: resolved and unresolved issue.MedComm · 2024Review
- Drug repurposing screen identifies lonafarnib as respiratory syncytial virus fusion protein inhibitor.Nature communications · 2024Article
- Responding to Higher-Than-Expected Infant Mortality Rates from Respiratory Syncytial Virus (RSV): Improving Treatment and Reporting Strategies.Infection and drug resistance · 2023Review
- PIK-24 Inhibits RSV-Induced Syncytium Formation via Direct Interaction with the p85α Subunit of PI3K.Journal of virology · 2022Article
- Predicting risk of progression to lower respiratory tract infection in allogeneic hematopoietic cell transplant recipients with respiratory viral infections: where are we now?Bone marrow transplantation · 2022Article
- Novel factors to predict respiratory viral disease progression in allogeneic hematopoietic cell transplant recipients.Bone marrow transplantation · 2022Article
- Antiviral Therapeutics in Pediatric Transplant Recipients.Infectious disease clinics of North America · 2022Review
- Article
- Review
- Antivirals targeting paramyxovirus membrane fusion.Current opinion in virology · 2021Review
- Risk of Transmission and Viral Shedding From the Time of Infection for Respiratory Syncytial Virus in Households.American journal of epidemiology · 2021Article
- Viral infections in lung transplantation.Journal of thoracic disease · 2021Review
- Review
Corrections and comments
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Authors and funding
30 authors at 20 institutions in 7 countries.
Funding
Abstract
backgroundHematopoietic-cell transplant (HCT) recipients are at risk for severe respiratory syncytial virus (RSV) infection. We evaluated the RSV fusion inhibitor presatovir in a randomized, double-blind, Phase II trial in HCT recipients with RSV upper respiratory tract infections.
methodsPatients were stratified by lymphopenia (<200/µL) and ribavirin use; were randomized, stratified by lymphopenia (<200/μL) and ribavirin use, to receive oral presatovir at 200 mg or a placebo on Days 1, 5, 9, 13, and 17, and were followed through Day 28. The coprimary efficacy endpoints were the time-weighted average change in the nasal RSV viral load between Days 1 and 9 and the proportion of patients developing lower respiratory tract complications (LRTCs) through Day 28.
resultsFrom 23 January 2015 to 16 June 2017, 189 patients were randomly assigned to treatment (96 to presatovir and 93 to the placebo). Presatovir treatment, compared with the placebo treatment, did not significantly affect (prespecified α = 0.01) a time-weighted average decline in the RSV viral load from Day 1 to 9 (treatment difference, -0.33 log10 copies/mL; 95% confidence interval [CI] -.64 to -.02 log10 copies/mL; P = .040) or the progression to LRTC (11.2% vs 19.5%, respectively; odds ratio, 0.50; 95% CI, .22-1.18; P = .11). In a post hoc analysis among patients with lymphopenia, presatovir decreased LRTC development by Day 28 (2/15 [13.3%] vs 9/14 [64.3%], respectively; P = .008), compared with the placebo. Adverse events were similar for patients receiving presatovir and the placebo.
conclusionsPresatovir had a favorable safety profile in adult HCT recipients with RSV but did not achieve the coprimary endpoints. Exploratory analyses suggest an antiviral effect among patients with lymphopenia. CLINICAL TRIALS REGISTRATION: NCT02254408; EUDRA-CT#2014-002474-36.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.