Mpox (monkeypox) Infections and Infestations
Conditions
Interventions
Eligible individuals who have provided and consent will be randomly allocated to tecovirimat or placebo. This will be done via a web-based randomisation program with allocation concealment, using a mi
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The participant inclusion criteria as of 21/11/2023: 1. Laboratory confirmed mpox infection 2. The presence of active skin or mucosal lesion(s) (defined as a skin lesion that is not scabbed or desquamated or a mucosal lesion that has not healed) 3. Patient is appropriate to be managed without hospitalisation 4. Women with reproductive potential must be willing to use effective contraception from the time of enrolment through study day 28 Previous participant inclusion criteria: 1. Laboratory confirmed monkeypox viral infection 2. The presence of active skin or mucosal lesion(s) (defined as a skin lesion that is not scabbed or desquamated or a mucosal lesion that has not healed) 3. Patient is appropriate to be managed without hospitalisation 4. Women with reproductive potential must be willing to use effective contraception from the time of enrolment through study day 28
Exclusion criteria
Exclusion criteria: 1. Weight <13 kg (children weighing more than this are eligible) 2. Use of contraindicated treatment (bupropion, repaglinide, voriconazole, rilpivirine, maraviroc, midazolam, atorvastatin, tacrolimus, methadone, flurbiprofen, phosphodiesterase type 5 inhibitors [sildenafil, tadalafil, vardenafil], darunavir, or proton pump inhibitors [lansoprazole, omeprazole, rabeprazole]) 3. Current or past use of tecovirimat 4. Lack of capacity to provide informed consent 5. The referring doctor considers there to be a definite indication for tecovirimat 6. Hypersensitivity to tecovirimat or any excipients in the study treatment 7. Current pregnancy or breastfeeding 8. Clinically determined severe renal impairment i.e., under the care of a nephrologist 9. Clinically determined severe hepatic impairment i.e. under the care of a hepatologist 10. Diagnosis of epilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to active lesion resolution, defined as the first day on which all skin lesions are scabbed or desquamated (and mucosal lesions healed) up to 28 days after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to complete lesion resolution, defined as the first day on which all lesions are completely resolved (all scabs dropped off and intact skin remains underneath, mucosal lesions healed) up to 28 days after randomisation 2. Time to negative throat swab viral culture, defined as time to consistently negative culture for monkeypox virus on throat swab at Days 7, 14, 21, and 28 3. Time to negative skin or mucosa swab viral culture, defined as time to consistently negative culture for monkeypox virus on swab of most recent active skin or mucosa lesion at Days 7, 14, 21, and 28 | — |
Countries
England, United Kingdom
Outcome results
None listed