ISRCTN17461766.

Study name	PLATINUM
Methods	Study setting: community ‐ non‐hospitalized patients who are well enough to remain at home Study design: interventional double‐blind randomized parallel‐group placebo‐controlled trial Dates of recruitment: 18 August 2022 Eligibility criteria: people with laboratory‐confirmed mpox who are well enough to be at home Inclusion criteria Laboratory confirmed monkeypox viral infection 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) Participant is appropriate to be managed without hospitalization Women with reproductive potential must be willing to use effective contraception from the time of enrolment through study day 28 Exclusion criteria Weight < 13 kg (children weighing more than this are eligible) 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]) Current or past use of tecovirimat Lack of capacity to provide informed consent The referring doctor considers there to be a definite indication for tecovirimat Hypersensitivity to tecovirimat or any excipients in the study treatment Current pregnancy or breastfeeding Clinically determined severe renal impairment i.e., under the care of a nephrologist Clinically determined severe hepatic impairment i.e. under the care of a hepatologist Diagnosis of epilepsy Length of follow‐up: 28 days Loss to follow‐up: not applicable, ongoing Adherence to assigned treatment: not applicable, ongoing
Participants	Number of participants: 500 Source of participants: enroled by doctors Age: any Sex: any Disease severity: not stated but non‐hospitalized patients so unlikely to be severe disease. Inclusion criteria states 'well enough to be at home.' Vaccination status: not stated Concurrent treatments: not stated Pregnancy: none Comorbidities: not stated
Interventions	Intervention Therapeutic: tecovirimat Route of administration: oral capsule Dosage, timing, frequency and duration Adults aged 18 years or older: three capsules twice a day for 14 days (total daily tecovirimat dose: 1200 mg) Children and adolescents aged < 18 years Estimated body weight ≥ 13 to < 25 kg: one capsule twice a day for 14 days (total daily tecovirimat dose: 400 mg) Estimated body weight ≥ 25 to < 40 kg: two capsules twice a day for 14 days (total daily tecovirimat dose: 800 mg) Estimated body weight ≥ 40 kg: three capsules twice a day for 14 days (total daily tecovirimat dose: 1200 mg) Control Type: identical placebo Route of administration: oral capsule Dosage, timing, frequency and duration: Identical to intervention
Outcomes	Primary 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 randomization Secondary 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 randomization 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 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
Starting date	18 August 2022
Contact information	platinumtrial@ndph.ox.ac.uk
Notes	Author: Prof. Sir Peter Horby, platinumtrial@ndph.ox.ac.uk Title: Antiviral treatment with tecovirimat for patients managed at home with monkeypox (PLATINUM) Publication date: ongoing, estimated completion date June 2023 Country: UK Funding details: National Institute for Health and Care Research (UK) CoI statement: not stated