SuspendedPhase 3

Tecovirimat in Non-hospitalized Patients With Monkeypox

Stopped: The recommendations of the Data Safety Monitoring Committee, based on the results of the STOMP Study (NCT05534984).

Canada120 participantsStarted 2023-08-14

Plain-language summary

PLATINUM-CAN is a parallel collaborative trial linked with the sister trial PLATINUM led by Oxford University. PLATINUM-CAN is a multi-centre, randomized, placebo-controlled trial of Tecovirimat in non-hospitalized patients with presumptive or PCR confirmed monkeypox infection. The study will provide evidence on the efficacy and safety of Tecovirimat for laboratory-confirmed monkeypox in outpatients with monkeypox infection and determine the feasibility of conducting interventional monkeypox trials in Canada.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Any sex, ≥ 18 years of age inclusive at the time of signing informed consent.
✓. Weight ≥ 40 kg
✓. Laboratory-confirmed or presumptive monkeypox infection:
✓. Appropriate to be managed without hospitalization.
✓. The participant (or legally acceptable representative) has provided documented informed consent and comply to the require procedures for the study.

Exclusion criteria

✕. Weight \< 40 kg
✕. Current or past use of tecovirimat
✕. Inability to provide informed consent
✕. The patient's own doctor considers there to be either a definite indication or a definite contraindication to the patient receiving tecovirimat
✕. Participated in an interventional clinical study \< 28 days prior to the day of first IP administration (Day 0) or plans to do so while enrolled in this study.

What they're measuring

Time to active lesion resolution

Timeframe: Up to 28 days after randomization

Feasibility and acceptability of conducting a pragmatic phase 3 interventional trial for outpatients with Monkeypox in Canada

Timeframe: 4 months

Trial details

NCT IDNCT05534165

SponsorMarina Klein

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-13

View on ClinicalTrials.gov More Monkeypox trials