Mpox
Conditions
Interventions
Participants with symptomatic Mpox 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 followe
Sponsors
Ohmagari Norio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Laboratory-confirmed or presumptive Mpox. 2.Mpox 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).
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to clinical resolution defined as all skin lesions being scabbed, desquamated, or healed, and all visible mucosal lesions being healed. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare pain scores between randomized arms. 2. To compare rates of progression to severe Mpox between randomized arms. 3. To compare clearance of Mpox 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 Mpox, 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. | — |
Countries
Argentina, Brazil, Japan, Mexico, Peru, Puerto Rico, South Africa, USA
Contacts
Public ContactSho Saito
Japan Institute for Health Security National Center for Global Health and Medicine
Outcome results
None listed