Study of Tecovirimat for Human Mpox Virus (NCT05534984) | Clinical Trial Compass
TerminatedPhase 3
Study of Tecovirimat for Human Mpox Virus
Stopped: DSMB recommendation due to statistical futility
United States, Argentina, Brazil719 participantsStarted 2022-09-08
Plain-language 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).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Laboratory-confirmed or presumptive human mpox virus (HMPXV) infection.
. HMPXV illness of \<14 days duration immediately prior to study entry.
. At least one active (not yet scabbed) skin lesion, mouth lesion, or proctitis with or without visible ulcers.
. 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.
. 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.
. For participants to be enrolled/followed remotely, ability and willingness to participate in remote telehealth assessments (i.e., video visits).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative Proportion With Clinical Resolution by Day 29
Timeframe: From study entry through 28 days of follow-up (i.e., Day 29)
Trial details
NCT IDNCT05534984
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Those with severe HMPXV disease defined as having one or more of the following conditions:
Exclusion criteria
. Prior or concomitant receipt of tecovirimat (e.g., under an alternative access mechanism.
. 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.
. Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study.
. Participants who require intravenous dosing of tecovirimat.