Study of Tecovirimat for Human Monkeypox Virus (STOMP)

April 16, 2024 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible and consented participants for the randomized arms (N=530) will be randomized 2:1 to receive either tecovirimat or placebo; participants with severe disease, significant skin conditions, participants with severe immune suppression will receive open-label tecovirimat. Participants who are pregnant or breastfeeding will receive open-label tecovirimat after discussion of the potential risks and benefits. Participants less than 18 years of age will receive open-label tecovirimat. Participants receiving a potent inducing concomitant medication will receive open-label tecovirimat.

Once enrolled, study drug administration will be for 14 days. Participants who progress to severe HMPXV disease will be seen in person for a confirmation of progression. If severe disease is confirmed, participants will stop blinded study treatment and start a 14-day course of open-label tecovirimat. Participants reporting severe pain 5 days after randomization will stop blinded study treatment and start a 14-day course of open-label tecovirimat.

Participants will self-monitor skin and/or mucosal lesions daily through 29 days or resolution (whichever comes first), complete a daily diary of symptoms and complete a daily numerical rating scale for pain assessment.

Participants will be seen weekly through day 29 for assessment of HMPXV disease, safety assessments, HMPXV sampling similar to that described for entry, and swabbing of new HMPXV lesions.

Participants will be seen at day 57 to assess for possible recrudescence of infection (i.e., new lesions occurring after initial resolution of disease.

Study Type

Interventional

Enrollment (Estimated)

530

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: ACTG Clinicaltrials.gov Coordinator
  • Phone Number: Please email at:
  • Email: ACTGCT.gov@fstrf.org

Study Locations

  • Argentina
  • Brazil
      • Porto Alegre, Brazil
        • Recruiting
        • Hospital Nossa Senhora da Conceicao CRS
        • Contact:
      • São Paulo, Brazil
      • São Paulo, Brazil
        • Not yet recruiting
        • Centro de Referencia e Treinamento DST/AIDS CRS
        • Contact:
  • Japan
      • Tokyo, Japan
  • Mexico
      • Mexico City, Mexico
        • Recruiting
        • Nutricion Mexico CRS
        • Contact:
  • Peru
      • Callao, Peru
        • Recruiting
        • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) CRS
        • Contact:
          • Juan Jose Montenegro, IoR
      • Lima, Peru
      • Lima, Peru
      • Lima, Peru
        • Recruiting
        • Socios En Salud Sucursal Peru
        • Contact:
      • Lima, Peru
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Recruiting
        • IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS
        • Contact:
      • San Juan, Puerto Rico, 00935
        • Recruiting
        • Puerto Rico AIDS Clinical Trials Unit CRS
        • Contact:
  • South Africa
      • Johannesburg, South Africa
      • Johannesburg, South Africa
        • Not yet recruiting
        • University of the Witwatersrand Helen Joseph (WITS HJH)
        • Contact:
  • Thailand
      • Bangkok, Thailand
      • Bangkok, Thailand
        • Recruiting
        • Thai Red Cross AIDS Research Centre
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • Alabama CRS
        • Contact:
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Los Angeles Medical Center
        • Contact:
      • Los Angeles, California, United States, 90035
      • Los Angeles, California, United States, 90028
        • Recruiting
        • Los Angeles LGBT Center CRS
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • David Geffen School of Medicine at UCLA NICHD CRS
        • Contact:
      • Los Angeles, California, United States, 90033
        • Withdrawn
        • Usc La Nichd Crs
      • Oakland, California, United States, 94609
        • Not yet recruiting
        • Easy Bay AIDS Center CRS City: Oakland
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis CRS
        • Contact:
      • San Diego, California, United States, 92103
        • Recruiting
        • UCSD Antiviral Research Center CRS
        • Contact:
      • San Francisco, California, United States, 94110
        • Recruiting
        • University of California, San Francisco HIV/AIDS CRS
        • Contact:
      • Torrance, California, United States, 90502
        • Recruiting
        • Harbor University of California Los Angeles Center
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Aurora, Colorado, United States, 80045
      • Denver, Colorado, United States, 80204
        • Recruiting
        • Denver Public Health CRS
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School Of Medicine
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32610
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida Jacksonville NICHD CRS
        • Contact:
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami / Jackson Memorial Hospital
        • Contact:
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami/Pediatric Perinatal HIV NICHD CRS
        • Contact:
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Univ. of South Florida (USF) College of Medicine A
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • The Ponce de Leon Center CRS
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Cook County Hospital Chicago NICHD CRS
        • Contact:
      • Chicago, Illinois, United States, 60612
      • Chicago, Illinois, United States, 60611
        • Withdrawn
        • Ann & Robert H Lurie Children's Hospital of Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins University CRS
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital CRS (MGH CRS)
        • Contact:
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital Therapeutics
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital CRS
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University Therapeutics (WT) CRS
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center (Specialty Care Center)
        • Contact:
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Recruiting
        • New Jersey Medical School Clinical Research Center
        • Contact:
    • New York
      • Bronx, New York, United States, 10461
        • Recruiting
        • Jacobi Medical Center Bronx NICHD CRS
        • Contact:
      • New York, New York, United States, 10010
        • Recruiting
        • Weill Cornell Chelsea CRS
        • Contact:
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Uptown CRS
        • Contact:
      • New York, New York, United States, 10019
        • Recruiting
        • Mount Sinai West Samuels CRS
        • Contact:
      • New York, New York, United States, 10027
        • Recruiting
        • Harlem Prevention Center
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia Physicians & Surgeons (P&S) CRS
        • Contact:
      • New York, New York, United States, 10457
        • Recruiting
        • Bronx-Lebanon Hospital Center NICHD CRS
        • Contact:
      • New York, New York, United States, 11029
        • Recruiting
        • Infectious Disease Clinical and Translational Research
        • Contact:
      • Rochester, New York, United States, 14642
      • Stony Brook, New York, United States, 11794
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Completed
        • Duke University Medical Center CRS
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Medical Center CRS
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • Cincinnati CRS
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University CTU
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University CRS
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh CRS
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Children's Research Hospital ATN CRS
        • Contact:
      • Nashville, Tennessee, United States, 37204
        • Completed
        • Vanderbilt Therapeutics CRS
    • Texas
      • Dallas, Texas, United States, 75208
        • Recruiting
        • Trinity Health and Wellness Center CRS
        • Contact:
      • Dallas, Texas, United States, 75390
      • Dallas, Texas, United States, 75246
        • Recruiting
        • North Texas Infectious Disease Consultants
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine / Texas Children's Hospital NICHD CRS
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston AIDS Research Team (HART) CRS
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas, San Antonio
        • Contact:
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Completed
        • Virginia Commonwealth University Division of Infectious Diseases
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington Positive Research
        • Contact:
          • Rachel Bender-Ignacio, IoR
          • Phone Number: 206-744-4876
          • Email: rbi13@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (All participants; Arms A, B, and C):

  1. Laboratory-confirmed or presumptive 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.

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. Participants age <18 years at the time of study entry
  2. Those with severe HMPXV disease

Those with or without severe disease and with one or more of the following will also be enrolled into Arm C:

  • Severe immunosuppression
  • Skin conditions placing the person at higher risk for disseminated infection

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 are stable on long-acting intramuscular cabotegravir/rilpivirine may 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: Tecovirimat Oral Capsule

Drug: Tecovirimat Oral capsules

  • 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
Placebo Comparator: Arm B
Drug: Placebo

Drug: Placebo Oral capsules

  • 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
Experimental: Arm C
Drug: Tecovirimat Oral Capsule (Open Label)
  • Participants weighing 4 to <6kg and >7 days old - Tecovirimat 50mg every 12 hours for 14 days
  • Participants weighing 2.5 to <4kg and >7 days to <4 weeks old - Tecovirimat 20 mg every 12 hours for 14 days
  • Participants weighing 4 to <6kg and ≤7 days old - Tecovirimat 50mg every 24 hours for 14 days
  • Participants weighing 2.5 to <4 kg and ≤7 days old - Tecovirimat 20mg every 24 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 (2 capsules) 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to clinical resolution, defined as the first day on which all skin lesions are scabbed, desquamated or healed, and visible mucosal lesions are healed
Time Frame: Up to day 29
Up to day 29

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain assessed by 11-point numerical rating scale for pain
Time Frame: Through day 29
Through day 29
Time to development of severe HMPXV in those without severe HMPXV at baseline
Time Frame: Through day 57
Through day 57
Level of HMPXV in blood
Time Frame: Through day 57
Through day 57
Level of HMPXV in skin lesions
Time Frame: Through day 57
Through day 57
Level of HMPXV in oropharynx
Time Frame: Through day 57
Through day 57
Level of HMPXV in rectum
Time Frame: Through day 57
Through day 57
Level of HMPXV in genital secretions
Time Frame: Through day 57
Through day 57
Time to complete lesion healing defined as all lesions being re-epithelialized
Time Frame: Up to day 29
Up to day 29
Participant-reported adherence
Time Frame: Through day 15
Through day 15
Participant-reported quality-of-life as measured by EQ-5D-5L
Time Frame: Through day 29
Through day 29
Occurrence of Grade 3 or greater adverse event
Time Frame: Through day 57
Through day 57
All-cause mortality
Time Frame: Through day 57
Through day 57
Tecovirimat concentrations in blood in children less than 18 years of age
Time Frame: Through day 15
Through day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

SIGA Technologies

Investigators

  • Study Chair: Timothy Wilkin, MD, MPH, Cornell

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2022

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

September 8, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5418
  • 38982 (Other Identifier: DAIDS-ES ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie results in the publication after deidentification

IPD Sharing Time Frame

Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH

IPD Sharing Access Criteria

With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.

For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group.

By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Monkeypox

Clinical Trials on Tecovirimat Oral Capsule

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe