Trial reportThe Journal of infectious diseases2013
A randomized, double-blind placebo controlled trial of balapiravir, a polymerase inhibitor, in adult dengue patients.
Trial report in The Journal of infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01096576 (A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Dengue Virus Polymerase Inhibitor), which is not on this map. Cited by 132 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Dengue Virus Polymerase Inhibitor (Balapiravir) in Male Patients With Confirmed Dengue Virus Infection
Who cites it
132 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- A systematic mapping review of therapeutic clinical trials in dengue.PLoS neglected tropical diseases · 2026Pooled it
- Effectiveness of antiviral, immunomodulatory and platelet-enhancing agents for treatment of dengue infection: A systematic review.Virulence · 2025Pooled it
- Impact of a Nonfatal Dengue Episode on Disability-Adjusted Life Years: A Systematic Analysis.The American journal of tropical medicine and hygiene · 2018Pooled it
- Safety and Preliminary Efficacy of Dengue Monoclonal Antibody in Adult Patients: A Randomized Clinical Trial.JAMA network open · 2026Trial
- Safety, Pharmacokinetics, and Activity of AT-752, a Novel Nucleotide Prodrug with Pan-Serotype Activity against Dengue Virus: A Phase 2, Randomized, Double-Blind Study.The American journal of tropical medicine and hygiene · 2025Trial
- First-in-human trial evaluating safety and pharmacokinetics of AT-752, a novel nucleotide prodrug with pan-serotype activity against dengue virus.Antimicrobial agents and chemotherapy · 2024Trial
- Extended Evaluation of Virological, Immunological and Pharmacokinetic Endpoints of CELADEN: A Randomized, Placebo-Controlled Trial of Celgosivir in Dengue Fever Patients.PLoS neglected tropical diseases · 2016Trial
- Lovastatin for the Treatment of Adult Patients With Dengue: A Randomized, Double-Blind, Placebo-Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Trial
- Therapeutic approaches against dengue virus: current status of vaccines, antivirals, and monoclonal antibodies.Emerging microbes & infections · 2026Review
- Rethinking Clinical Trial Design to Accelerate Therapeutics for Arboviral Epidemics.Open forum infectious diseases · 2026Article
- Repeated-Dose High-Dose Ivermectin Pharmacokinetics and Safety in Children with Acute Dengue.Paediatric drugs · 2026Article
- Discovery of a 4'-Azido Fleximer Nucleoside Analog With Broad-Spectrum Antiviral Activity Against DENV, EBOV, and Other RNA Viruses.ChemMedChem · 2026Article
- Evaluating antiviral candidates for dengue virus infection: A review.Parasite epidemiology and control · 2026Review
- Achievements and Challenges in Therapy and Vaccines Development of Viral Hemorrhagic Fevers: An Up-to-Date Review.Pharmaceutics · 2026Review
- 1'- and 4'-Cyano Modified Adenosine Analogs Against Prototypic Flavivirus RNA-Dependent RNA Polymerases.Viruses · 2026Article
- NS5-targeting nucleoside analogs inhibit dengue virus and other flaviviruses.PLoS pathogens · 2026Article
- Prodrug strategies in developing antiviral nucleoside analogs.RSC medicinal chemistry · 2026Review
- Dengue therapeutics consortium 2025: a global collaboration in action.BMJ public health · 2026Review
- Dengue and severe dengue.Clinical microbiology reviews · 2025Review
- Fisetin as an Antiviral Agent Targeting the RNA-Dependent RNA Polymerase of SARS-CoV-2: Computational Prediction and In Vitro Experimental Validation.Microorganisms · 2025Article
72 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
Abstract
backgroundDengue is the most common arboviral infection of humans. There are currently no specific treatments for dengue. Balapiravir is a prodrug of a nucleoside analogue (called R1479) and an inhibitor of hepatitis C virus replication in vivo.
methodsWe conducted in vitro experiments to determine the potency of balapiravir against dengue viruses and then an exploratory, dose-escalating, randomized placebo-controlled trial in adult male patients with dengue with <48 hours of fever.
resultsThe clinical and laboratory adverse event profile in patients receiving balapiravir at doses of 1500 mg (n = 10) or 3000 mg (n = 22) orally for 5 days was similar to that of patients receiving placebo (n = 32), indicating balapiravir was well tolerated. However, twice daily assessment of viremia and daily assessment of NS1 antigenemia indicated balapiravir did not measurably alter the kinetics of these virological markers, nor did it reduce the fever clearance time. The kinetics of plasma cytokine concentrations and the whole blood transcriptional profile were also not attenuated by balapiravir treatment.
conclusionsAlthough this trial, the first of its kind in dengue, does not support balapiravir as a candidate drug, it does establish a framework for antiviral treatment trials in dengue and provides the field with a clinically evaluated benchmark molecule. CLINICAL TRIALS REGISTRATION: NCT01096576.
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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.