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TERMINATED

NCT05534984

PHASE3

Study of Tecovirimat for Human Mpox Virus

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

The purpose of this study was to see if tecovirimat is safe and successful at treating mpox. The main questions were whether tecovirimat reduced time to lesion resolution and pain compared to placebo (no treatment).

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

719

Start Date

2022-09-08

Completion Date

2025-02-22

Last Updated

2026-06-23

Healthy Volunteers

Conditions

MPOX

Interventions

DRUG

Tecovirimat Oral Capsule

* Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days * Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days * Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days

DRUG

Placebo for Tecovirimat

* Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days * Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days * Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days

DRUG

Tecovirimat Oral Capsule (Open Label)

* Participants weighing \<3 kg - Tecovirimat 33.3 mg every 12 hours for 14 days * Participants weighing 3 kg to less than 6 kg- Tecovirimat 50 mg every 12 hours for 14 days * Participants weighing 6 kg to less than 13 kg - Tecovirimat 100 mg every 12 hours for 14 days * Participants weighing 13 kg to less than 25 kg - Tecovirimat 200 mg every 12 hours for 14 days * Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days * Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days * Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days

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.

Locations (54)

Alabama CRS

Birmingham, Alabama, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Los Angeles LGBT Center CRS

Los Angeles, California, United States

UCLA CARE Center CRS

Los Angeles, California, United States

University of California, Davis CRS

Sacramento, California, United States

UCSD Antiviral Research Center CRS

San Diego, California, United States

University of California, San Francisco HIV/AIDS CRS

San Francisco, California, United States

Harbor University of California Los Angeles Center

Torrance, California, United States

University of Colorado Denver NICHD CRS

Aurora, Colorado, United States

University of Colorado Hospital CRS

Aurora, Colorado, United States

Denver Public Health CRS

Denver, Colorado, United States

University of Florida

Gainesville, Florida, United States

University of Florida Jacksonville NICHD CRS

Jacksonville, Florida, United States

University of Miami / Jackson Memorial Hospital

Miami, Florida, United States

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

Tampa, Florida, United States

The Ponce de Leon Center CRS

Atlanta, Georgia, United States

Rush University Cook County Hospital Chicago NICHD CRS

Chicago, Illinois, United States

Johns Hopkins University CRS

Baltimore, Maryland, United States

Massachusetts General Hospital CRS (MGH CRS)

Boston, Massachusetts, United States

Brigham and Women's Hospital Therapeutics

Boston, Massachusetts, United States

Henry Ford Hospital CRS

Detroit, Michigan, United States

Washington University Therapeutics (WT) CRS

St Louis, Missouri, United States

New Jersey Medical School Clinical Research Center

Newark, New Jersey, United States

Weill Cornell Chelsea CRS