Tecovirimat in Non-hospitalized Patients With Monkeypox (NCT05534165) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to active lesion resolution
Timeframe: Up to 28 days after randomization
2
Feasibility and acceptability of conducting a pragmatic phase 3 interventional trial for outpatients with Monkeypox in Canada
. 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.