A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease.

Ohmagari Norio0 个研究点目标入组 20 人开始时间: 2023年11月22日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•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.
•5.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.
•6.For participants to be enrolled/followed remotely, ability and willingness to participate in remote telehealth assessments (i.e., video visits).

•1.Prior or concomitant receipt of tecovirimat.
•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.

发起方

Ohmagari Norio