Tecovirimat in Non-hospitalized Patients With Monkeypox

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marina Klein
• Collaborators: CIHR Canadian HIV Trials Network; McGill University Health Centre/Research Institute of the McGill University Health Centre; Unity Health Toronto; University Health Network, Toronto; University of British Columbia

Criteria

Inclusion Criteria:

1. Any sex, ≥ 18 years of age inclusive at the time of signing informed consent.

2. Weight ≥ 40 kg

3. Laboratory-confirmed or presumptive monkeypox infection:

Laboratory-confirmed monkeypox infection is defined as determined by PCR, culture, or antigen test obtained from a sample collected from blood, oropharynx, anal or skin lesion within 4 days of randomization OR

Presumptive diagnosis:

• Skin lesion(s), mucosal lesion(s) or proctitis consistent with a high probability of monkeypox infection in the opinion of the site investigator AND

• Sexual contact with 1 or more persons in the 21 days prior to symptom onset or any person with known close exposure to another person known to be infected with monkeypox infection. Presence of active skin or mucosal lesion(s).

4. Appropriate to be managed without hospitalization.

5. The participant (or legally acceptable representative) has provided documented informed consent and comply to the require procedures for the study.

Exclusion Criteria:

1. Weight < 40 kg

2. Current or past use of tecovirimat

3. Inability to provide informed consent

4. The patient's own doctor considers there to be either a definite indication or a definite contraindication to the patient receiving tecovirimat

5. 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.