Monkeypox
Conditions
Interventions
Sponsors
PANTHER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. - Signed informed consent or assent for minor participants - Adults with positive mpox virus PCR confirmed within 7 days of Day (D) 1 and at least one skin lesion - With known HIV or - With Mucosal lesions - Children with positive mpox virus PCR confirmed within 7 days of D1 and at least one skin lesion - Newborn with positive mpox virus PCR confirmed within 7 days of D1 and at least one skin lesion - Specific to the BCV arm and matching placebo-Women participants of childbearing potential willing to use condoms during treatment and for at least 2 months after the last dose of BCV - Specific to the BCV arm and matching placebo-Male participants with partners of chilbearing potential willing to use condoms during treatment and for at least 4 months after the last dose of BCV i. To protect women of a potential teratogenic treatment ii. and anyhow for MSM (men who have sex with men) to avoid contamination
Exclusion criteria
Exclusion criteria: 1. - Current or planned use of another investigational drug at any point during study participation. - Ongoing treatment which cannot be interrupted and for which a major interaction has been described with IP. - Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study (for example: if the investigator judges that an antiviral treatment is not indicated). - Known hypersensitivity to a substance in the IP - Use of concomitant medications that are contraindicated with IP - Unwilling or unable to comply with the requirements of the study protocol at any time during the study. - Specific to the BCV arm and matching placebo- pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time for all visible lesions (skin, mucosal or rectal) to heal with a new fresh layer of skin re-epithelialization (i.e. resurfacing of a wound) with a new epithelium layer (up to visit Day 28) | — |
Secondary
| Measure | Time frame |
|---|---|
| • All-cause mortality within the first 28 days (applied to all subjectsparticipants) • All-cause unplanned admission to hospital within first 28 days (applies to outpatients) • Occurrence of subjectsparticipants with a complication within first 28 days (applies to all subjectsparticipants who did not already have a complication at baseline) • Time to resolution of symptoms and signs within first 28 days (applies to all subjectsparticipants) • Frequency of adverse events (AEs) and serious adverse events (SAEs) and proportion of drug discontinuation | — |
Countries
Congo, Madagascar, Uganda
Contacts
Public ContactNathalie Strub Wourgaft
General Delegate
Outcome results
None listed