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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 through day 57
Awards & highlights
STOMP 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.Check my eligibility
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.See study design
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.
STOMP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through day 57
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 57
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
All-cause mortality
Level of HMPXV in blood
Level of HMPXV in genital secretions
+10 moreSTOMP 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
3,269 Previous Clinical Trials
5,480,939 Total Patients Enrolled
3 Trials studying Monkeypox
1,829 Patients Enrolled for Monkeypox
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.
Monkeypox Patient Testimony for trial: Trial Name: NCT05534984 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Tecovirimat Oral Capsule gone through FDA approval yet?
"Tecovirimat Oral Capsule has received a safety score of 3."
Answered by AI
If a patient wanted to enroll today, would they be able to?
"That is correct. The most recent information available on clinicaltrials.gov shows that this trial is still looking for participants. The study was first posted on September 12th, 2022 and last updated November 10th, 2022. A total of 530 patients need to be recruited from 69 different sites."
Answered by AI
Where are patients being treated as part of this experiment?
"At 69 sites currently, this study will soon be conducted in your area. Stony Brook, San Antonio, Detroit, and other locations near you are participating. To limit travel as a time commitment, please choose the location closest to you when signing up."
Answered by AI
How many research participants are being recruited for this experiment?
"That is correct. The listing on clinicaltrials.gov indicates that this study is recruiting patients at 69 sites across the globe. So far, 530 people have been enrolled in the trial since it was originally posted on September 12th, 2020."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Baylor College of Medicine / Texas Children's Hospital NICHD CRS
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have been involved with studies for a few times.
PatientReceived no prior treatments
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