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Study of Tecovirimat for Human Monkeypox Virus (STOMP)

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ClinicalTrials.gov Identifier: NCT05534984
Recruitment Status : Recruiting
First Posted : September 10, 2022
Last Update Posted : August 31, 2023
Sponsor:
Collaborator:
SIGA Technologies
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Monkeypox MPOX Drug: Tecovirimat Oral Capsule Drug: Placebo Drug: Tecovirimat Oral Capsule (Open Label) Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease
Actual Study Start Date : September 12, 2022
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Tecovirimat

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05534984


Contacts
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Contact: ACTG Clinicaltrials.gov Coordinator Please email at: ACTGCT.gov@fstrf.org

Locations
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Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
SIGA Technologies
Investigators
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Study Chair: Timothy Wilkin, MD, MPH Cornell
More Information
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT05534984    
Other Study ID Numbers: A5418
38982 ( Other Identifier: DAIDS-ES ID )
First Posted: September 10, 2022    Key Record Dates
Last Update Posted: August 31, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie results in the publication after deidentification
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HMPXV
Additional relevant MeSH terms:
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Monkeypox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
 Infections
Tecovirimat
Antiviral Agents
Anti-Infective Agents