Trial reportThe New England journal of medicine2018
Oral Tecovirimat for the Treatment of Smallpox.
Trial report in The New England journal of medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 186 papers, 6 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.
An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects
European Randomised Clinical Trial on mPOX Infection
Who cites it
186 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- The impact of human immunodeficiency virus coinfection on mpox patients during the 2022 global outbreak: a systematic review and meta-analysis based on comparative observational studies.Frontiers in microbiology · 2026Pooled it
- Clinical Features, Antiviral Treatment, and Patient Outcomes: A Systematic Review and Comparative Analysis of the Previous and the 2022 Mpox Outbreaks.The Journal of infectious diseases · 2023Pooled it
- Can the current monkeypox affect the heart? A systematic review of case series and case report.BMC cardiovascular disorders · 2023Pooled it
- Therapeutics for treating mpox in humans.The Cochrane database of systematic reviews · 2023Pooled it
- Monkeypox and oral lesions associated with its occurrence: a systematic review and meta-analysis.F1000Research · 2023Pooled it
- Pooled it
- Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo.The New England journal of medicine · 2025Trial
- Assessment of three antiviral compounds against Borealpox virus infection in a mouse model.Emerging microbes & infections · 2026Article
- A comprehensive overview of monkeypox virus disease.Tropical medicine and health · 2026Review
- Distinct Inflammatory Immune Signature in Acute Mpox Associated With Proctitis.Open forum infectious diseases · 2026Article
- Exploration of the protein and pharmacological landscape of monkeypox virus treatment: from entry point to end point.Molecular diversity · 2026Review
- Exploring drug repurposing for monkeypox virus: A structural and computational approach.Journal of Taibah University Medical Sciences · 2026Article
- Mpox emergence, epidemiology, biology, clinical features and control.Nature reviews. Microbiology · 2026Review
- 3-Hydroxypyrimidine-2,4-dione derivatives as monkeypox virus resolvase (Mpr) inhibitors.RSC medicinal chemistry · 2026Article
- Dose-dependent pathogenicity and inflammatory imbalance in severely immunodeficient mice infected with mpox virus.Animal models and experimental medicine · 2026Article
- Primary human intestinal organoids model enteric infection of monkeypox virus and enable scalable drug discovery.Science advances · 2026Article
- Cellular lipids: fundamental host factors for monkeypox virus replication and pathogenesis.Archives of microbiology · 2026Review
- Tecovirimat for the Treatment of Mpox.The New England journal of medicine · 2026Article
- Tecovirimat-Related Substance: Characterization, Hirshfeld Analysis, Theoretical Study, In Silico Toxicity Assessment.Molecules (Basel, Switzerland) · 2026Article
- Monkeypox Virus Shedding Despite Tecovirimat Treatment in a Cohort in Toronto, Canada.The Journal of infectious diseases · 2026Article
126 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
10 authors.
Funding
Abstract
backgroundSmallpox was declared eradicated in 1980, but variola virus (VARV), which causes smallpox, still exists. There is no known effective treatment for smallpox; therefore, tecovirimat is being developed as an oral smallpox therapy. Because clinical trials in a context of natural disease are not possible, an alternative developmental path to evaluate efficacy and safety was needed.
methodsWe investigated the efficacy of tecovirimat in nonhuman primate (monkeypox) and rabbit (rabbitpox) models in accordance with the Food and Drug Administration (FDA) Animal Efficacy Rule, which was interpreted for smallpox therapeutics by an expert advisory committee. We also conducted a placebo-controlled pharmacokinetic and safety trial involving 449 adult volunteers.
resultsThe minimum dose of tecovirimat required in order to achieve more than 90% survival in the monkeypox model was 10 mg per kilogram of body weight for 14 days, and a dose of 40 mg per kilogram for 14 days was similarly efficacious in the rabbitpox model. Although the effective dose per kilogram was higher in rabbits, exposure was lower, with a mean steady-state maximum, minimum, and average (mean) concentration (C
conclusionsOn the basis of its efficacy in two animal models and pharmacokinetic and safety data in humans, tecovirimat is being advanced as a therapy for smallpox in accordance with the FDA Animal Rule. (Funded by the National Institutes of Health and the Biomedical Advanced Research and Development Authority; ClinicalTrials.gov number, NCT02474589 .).
Indexed as
Identifiers
What OpenQuestion holds
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.