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Tecovirimat for Monkeypox (STOMP Trial)
Phase 3
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Summary
This trial will test if tecovirimat can treat people with laboratory-confirmed or presumptive HMPXV disease.
Who is the study for?
Adults (≥18 years) with confirmed or suspected Monkeypox virus infection, showing symptoms for less than 14 days and at least one active lesion. Must agree to use contraception if of reproductive potential. Children, severely ill patients, those with severe immunosuppression or skin conditions that increase risk are in a separate group.
What is being tested?
The study is testing the effectiveness of Tecovirimat capsules against Monkeypox compared to a placebo. Participants are randomly assigned to receive either the medication or placebo without knowing which they're getting. There's also an open-label part for certain participants.
What are the potential side effects?
While specific side effects for this trial aren't listed, Tecovirimat may generally cause headache, nausea, abdominal pain and fatigue. Side effects can vary from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm CExperimental Treatment1 Intervention
Group II: Arm AExperimental Treatment1 Intervention
Group III: Arm BPlacebo Group1 Intervention
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Who is running the clinical trial?
SIGA TechnologistUNKNOWN
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,326 Previous Clinical Trials
5,365,347 Total Patients Enrolled
SIGA TechnologiesIndustry Sponsor
10 Previous Clinical Trials
1,243 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been sick with HMPXV for less than 14 days.I am 18 years old or older.I need tecovirimat through an IV.I plan to start or continue cabotegravir/rilpivirine injections during or after the study.I have at least one active skin, mouth lesion, or proctitis.My illness started less than 14 days ago.I have severe immunosuppression or skin conditions that increase my risk of widespread infection.I am under 18 or have severe HMPXV disease for Arm C.I have previously taken or am currently taking tecovirimat.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
- Group 3: Arm C
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Multiplex Polymerase Chain Reaction Patient Testimony for trial: Trial Name: NCT05534984 — Phase 3
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