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Mpox drug trial halted: did tecovirimat help?

NCT ID NCT05534984

Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether the drug tecovirimat could safely treat mpox and speed up recovery. About 719 people with mpox took either tecovirimat or a placebo. The main goals were to see if the drug reduced the time for skin lesions to heal and lessened pain. The study was terminated early, and results are still being analyzed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

719 people

The number who actually took part.

Started

Sep 2022

Finished

Feb 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (All participants; Arms A, B, and C): 1. Laboratory-confirmed or presumptive human mpox virus (HMPXV) infection. 2. HMPXV illness of \<14 days duration immediately prior to study entry. 3. At least one active (not yet scabbed) skin lesion, mouth lesion, or proctitis with or without visible ulcers. 4. Non-pregnant people of reproductive potential must agree to use at least one effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation. 5. Ability to provide informed consent (for those above the legal age of consent and those providing consent for minors) and assent (for those who have reached the age of assent, but not the legal age of consent), as allowed by local ethics committees. 6. For participants to be enrolled/followed remotely, ability and willingness to participate in remote telehealth assessments (i.e., video visits). Additional Inclusion Criteria for Arms A and B: 1\. Age ≥18 years at the time of study entry. Additional Inclusion Criteria for Arm C: Participants who meet the above entry criteria who also meet any of the following criteria will be registered to Arm C. 1. Age \<18 years at the time of study entry. 2. Those with severe HMPXV disease defined as having one or more of the following conditions: * Suspected or confirmed ocular involvement * Facial lesions on the malar, nose, or eyelid region * Confluent facial lesions * Hospitalization due to HMPXV infection or its complications * Lesions that require surgical intervention including debridement, urinary catheterization or sigmoidoscopy, or lesions extending below the dermis. Those with or without severe disease and with one or more of the following: * Severe immunosuppression * Active skin conditions placing the person at higher risk for disseminated infection * Breastfeeding * Pregnancy * Receipt of potent inducers * Current or planned use of another investigational drug at any point during tecovirimat/placebo dosing that would be predicted to have a significant drug-drug interaction with tecovirimat therapeutics. Exclusion Criteria (All participants; Arms A, B, and C): 1. Prior or concomitant receipt of tecovirimat (e.g., under an alternative access mechanism. 2. Planned initiation of intramuscular cabotegravir/rilpivirine during study drug administration or for two weeks following completion of study drug administration. Participants who were stable on long-acting intramuscular cabotegravir/rilpivirine were allowed to enroll. 3. Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study. 4. Participants who require intravenous dosing of tecovirimat.

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Conditions

The condition(s) this trial relates to.

monkeypox

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mpox

Contacts and locations

Locations

  • Alabama CRS

    Birmingham, Alabama, 35294, United States

  • Barranco CRS

    Lima, Peru

  • Brigham and Women's Hospital Therapeutics

    Boston, Massachusetts, 02115, United States

  • Bronx-Lebanon Hospital Center NICHD CRS

    New York, New York, 10457, United States

  • Case Western Reserve University CTU

    Cleveland, Ohio, 44106, United States

  • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) CRS

    Callao, Peru

  • Centro de Pesquisas Clínicas IC-HCFMUSP CRS

    São Paulo, Brazil

  • Cincinnati CRS

    Cincinnati, Ohio, 45267, United States

  • Columbia Physicians & Surgeons (P&S) CRS

    New York, New York, 10032, United States

  • Denver Public Health CRS

    Denver, Colorado, 80204, United States

  • Duke University Medical Center CRS

    Durham, North Carolina, 27710, United States

  • Fundacion Huesped CRS

    Buenos Aires, Argentina

  • Harbor University of California Los Angeles Center

    Torrance, California, 90502, United States

  • Harlem Prevention Center

    New York, New York, 10027, United States

  • Henry Ford Hospital CRS

    Detroit, Michigan, 48202, United States

  • Houston AIDS Research Team (HART) CRS

    Houston, Texas, 77030, United States

  • Infectious Disease Clinical and Translational Research

    New York, New York, 11029, United States

  • Johns Hopkins University CRS

    Baltimore, Maryland, 21205, United States

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027, United States

  • Los Angeles LGBT Center CRS

    Los Angeles, California, 90028, United States

  • Massachusetts General Hospital CRS (MGH CRS)

    Boston, Massachusetts, 02114, United States

  • Mount Sinai West Samuels CRS

    New York, New York, 10019, United States

  • New Jersey Medical School Clinical Research Center

    Newark, New Jersey, 07103, United States

  • North Texas Infectious Disease Consultants

    Dallas, Texas, 75246, United States

  • Nutricion Mexico CRS

    Mexico City, Mexico

  • Ohio State University CRS

    Columbus, Ohio, 43210, United States

  • Penn Therapeutics CRS

    Philadelphia, Pennsylvania, 19104, United States

  • Rush University Cook County Hospital Chicago NICHD CRS

    Chicago, Illinois, 60612, United States

  • SUNY Stony Brook NICHD CRS

    Stony Brook, New York, 11794, United States

  • San Miguel CRS

    Lima, Peru

  • Socios En Salud Sucursal Peru

    Lima, Peru

  • St. Jude Children's Research Hospital ATN CRS

    Memphis, Tennessee, 38105, United States

  • Thai Red Cross AIDS Research Centre

    Bangkok, Thailand

  • The Ponce de Leon Center CRS

    Atlanta, Georgia, 30308, United States

  • UCLA CARE Center CRS

    Los Angeles, California, 90035, United States

  • UCSD Antiviral Research Center CRS

    San Diego, California, 92103, United States

  • UT Southwestern Infectious Disease Research Unit

    Dallas, Texas, 75390, United States

  • Univ. of South Florida (USF) College of Medicine A

    Tampa, Florida, 33606, United States

  • University of California, Davis CRS

    Sacramento, California, 95817, United States

  • University of California, San Francisco HIV/AIDS CRS

    San Francisco, California, 94110, United States

  • University of Colorado Denver NICHD CRS

    Aurora, Colorado, 80045, United States

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80045, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Florida Jacksonville NICHD CRS

    Jacksonville, Florida, 32209, United States

  • University of Miami / Jackson Memorial Hospital

    Miami, Florida, 33136, United States

  • University of Pittsburgh CRS

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Adult HIV Therapeutic

    Rochester, New York, 14642, United States

  • University of Washington Positive Research

    Seattle, Washington, 98104, United States

  • Vaccine Trial Centre, Mahidol University CRS

    Bangkok, Thailand

  • Via Libre CRS

    Lima, Peru

  • Wake Forest Baptist Medical Center CRS

    Winston-Salem, North Carolina, 27157, United States

  • Washington University Therapeutics (WT) CRS

    St Louis, Missouri, 63110, United States

  • Weill Cornell Chelsea CRS

    New York, New York, 10010, United States

  • Weill Cornell Uptown CRS

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.