Evidence mapPaperPMID 41740032Full record

ArticleThe New England journal of medicine2026

Tecovirimat for the Treatment of Mpox.

Jason Zucker, William A Fischer, Lu Zheng, Caitlyn McCarthy, Pooja T Saha, Arzhang Cyrus Javan, Alex Greninger, Matthew M Hamill, Kieron Leslie, Kristina M Brooks and 18 more

Registry-linked trialAbstract read
In one paragraph

Article in The New England journal of medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05534984 (A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Mpox Virus Disease), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT05534984 phase3terminatednot on this map

A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Mpox Virus Disease

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2022 to 2025Enrolled719ConditionsMPOXArmsTecovirimat Oral Capsule, Placebo for Tecovirimat, Tecovirimat Oral Capsule (Open Label)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Mpox in Solid Organ Transplant Recipients: Lessons From a Single-Center Case Series in South Florida.Transplant infectious disease : an official journal of the Transplantation Society
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Jason ZuckerDivision of Infectious Diseases, Columbia University Irving Medical Center, New York.
William A FischerInstitute for Global Health and Infectious Diseases, Division of Pulmonary Diseases and Critical Care Medicine, University of North Carolina at Chapel Hill, Chapel Hill.
Lu ZhengCenter for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston.
Caitlyn McCarthyCenter for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston.
Pooja T SahaCenter for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston.
Arzhang Cyrus JavanDivision of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD.
Alex GreningerDepartment of Laboratory Medicine and Pathology, University of Washington Medical Center, Seattle.
Matthew M HamillJohns Hopkins University School of Medicine, Baltimore.ORCID 0000-0002-1277-819X
Kieron LeslieDepartment of Dermatology, University of California, San Francisco, San Francisco.
Kristina M BrooksDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora.
Jonathan BerardiDivision of Infectious Diseases, Rutgers New Jersey Medical School, Newark.ORCID 0000-0003-3415-2056
Davey SmithDepartment of Medicine, University of California, San Diego, La Jolla.
Lara HoseyAdvancing Clinical Therapeutics Network Coordinating Center, DLH, Atlanta.
Grace AldrovandiDepartment of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles.
Kathie FerbasDepartment of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles.
Cheryl DayDepartment of Microbiology and Immunology, Emory University School of Medicine, Atlanta.
Rachel A Bender IgnacioDivision of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle.ORCID 0000-0001-6167-1447
Robert BolanLos Angeles LGBT Center, Los Angeles.
Marshall J GlesbyDivision of Infectious Disease, Weill Cornell Medical College, New York.
Raphael J LandovitzDivision of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles.
Anne F LuetkemeyerDepartment of Medicine, University of California, San Francisco, San Francisco.ORCID 0000-0003-0911-1578
Juan Sierra MaderoInstituto Nacional de Ciencias Médicas y Nutrición, Mexico City.
Rajesh T GandhiMassachusetts General Hospital, Boston.
Sharon NachmanHealth Sciences Center, Department of Pediatrics, State University of New York Stony Brook, Stony Brook.
Joe EronDivision of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill.
Judith S CurrierDivision of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles.
Timothy WilkinDivision of Infectious Diseases and Global Public Health, University of California, San Diego, La Jolla.
STOMP/A5418 Investigators

Funding

AIDS Clinical Trials Group for Research on Therapeutics for HIV and Related InfectionsUM1AI068636 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2021 to 2025
$229.0M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2021 to 2025
$81.6M
AIDS Clinical Trial Group Laboratory CenterUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2021 to 2025
$54.5M
Seattle-Lausanne Clinical Trials UnitUM1AI069481 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · 2021 to 2025
$8.6M
San Francisco Bay Clinical Trials Unit (CTU)UM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · 2021 to 2025
$8.3M
NIAID NIH HHS U01 AI068634NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

backgroundTecovirimat is approved for smallpox treatment under the Food and Drug Administration Animal Rule on the basis of efficacy in nonhuman primate models of mpox (previously known as monkeypox). However, the clinical efficacy of tecovirimat against human clade II mpox is unclear.

methodsIn a phase 3, international, double-blind, randomized, placebo-controlled trial, we evaluated the efficacy of oral tecovirimat in adults with laboratory-confirmed clade II mpox. Participants were randomly assigned in a 2:1 ratio to receive tecovirimat or placebo for 14 days. The primary outcome was clinical resolution, assessed in a time-to-event analysis in participants with active skin or mucosal lesions. Secondary outcomes included reduction in pain, assessed in all participants with laboratory-confirmed mpox and in those with severe pain at baseline (pain score, 7 to 10; scale, 0 [no pain] to 10 [worst pain imaginable]); complete lesion healing (assessed in a time-to-event analysis); viral DNA clearance; and safety.

resultsOf 412 participants who underwent randomization (275 to tecovirimat and 137 to placebo), 344 had laboratory-confirmed mpox, and 336 had active skin or mucosal lesions and were included in the primary analysis. By day 29, the estimated cumulative incidence of clinical resolution was 83% with tecovirimat and 84% with placebo; the competing-risks hazard ratio for clinical resolution was 0.98 (95% confidence interval [CI], 0.74 to 1.31; P = 0.89). No substantial between-group differences were seen in pain reduction among participants with severe pain (difference, 0.1 point; 95% CI, -0.8 to 1.0), in complete lesion healing (competing-risks hazard ratio, 0.97; 95% CI, 0.75 to 1.26), or in viral DNA clearance. The incidence of adverse events of grade 3 or higher was similar in the two groups (4% with tecovirimat and 3% with placebo).

conclusionsThis trial showed no evidence that tecovirimat therapy shortened the time to clinical resolution, reduced pain, or increased viral clearance among adults with clade II mpox. (Funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health; STOMP/A5418 ClinicalTrials.gov number, NCT05534984.).

Identifiers

PMID41740032
PMCPMC13440037

What Socratic holds

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LicenceCC BY-NC-ND
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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 Socratic graph.