Study of Tecovirimat for Human Monkeypox Virus.

JRCT ID: jRCT2031230473

Registered date:22/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Human Monkeypox Virus Disease
• Date of first enrollment: 02/02/2024
• Target sample size: 20
• Countries of recruitment: Argentina,Japan,Brazil,Japan,Mexico,Japan,Peru,Japan,Puerto Rico,Japan,South Africa,Japan,USA,Japan
• Study type: Interventional
• Intervention(s): Participants with symptomatic HMPXV who do not meet criteria for the open-label cohort will be randomized in a 2:1 ratio to tecovirimat or matching placebo for 14 days. All participants will be followed through a combination of virtual assessments, in-person visits, and daily self-reports for resolution of clinical disease, specimen collection to assess viral clearance, and participant reported outcomes through day 57.

Outcome(s)

• Primary Outcome: The time to clinical resolution defined as all skin lesions being scabbed, desquamated, or healed, and all visible mucosal lesions being healed.

Secondary Outcome

1. To compare pain scores between randomized arms.
2. To compare rates of progression to severe HMPXV disease between randomized arms.
3. To compare clearance of HMPXV between randomized arms in various compartments including blood, skin lesions, oropharynx, rectum, and genital secretions.
4. To compare time to complete lesion healing between randomized arms.
5. To compare participant-reported outcomes including adherence and EQ-5D-5L between randomized arms.
6. To evaluate the safety of tecovirimat as compared to placebo.
7. To describe time to lesion resolution, pain, clearance of HMPXV, time to complete lesion healing, participant-reported outcomes, and safety of tecovirimat in participants who receive open-label tecovirimat.
8. To determine the steady-state tecovirimat AUCtau and Ctau in children less than 18 years of age.
9. To evaluate the safety profile of 14 days of tecovirimat in children less than 18 years of age.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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).

Exclude criteria

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.

Related Information

• Primary Sponsor: Ohmagari Norio
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): NCT05534984