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 States719 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
SexALL
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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).
✓. Age \<18 years at the time of study entry.
✓. 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.
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)