Tecovirimat in Non-hospitalized Patients With Monkeypox

NCT05534165 | Suspended Phase 3 DMC

• 1 other identifier: CTN 338
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Monkeypox

Keywords

Tecovirimat; Randomized; Placebo-Controlled; Outpatients; Non-hospitalized; Feasibility

Outcome Measures

Primary Outcomes (2)

• Time to active lesion resolution

  Time (days) 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

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

  Number of eligible patients per month and proportion randomized

  4 months

Secondary Outcomes (4)

• Time to complete lesion resolution

  Up to 28 days after randomization

• Time to negative throat swab viral culture

  Days 7, 14, 21, and 28

• Time to negative skin or mucosa swab viral culture

  Days 7, 14, 21, and 28

• Secondary feasibility outcomes

  4 months

Other Outcomes (8)

• Clinical status

  day 7, 14, 21 and 28

• Throat swab monkeypox DNA levels

  day 7, 14, 21 and 28

• Hospitalization rates

  study duration

Study Arms (2)

Tecovirimat

EXPERIMENTAL

Tecovirimat (TPOXX®) Capsules, 200 mg (as tecovirimat monohydrate) administered as 600 mg (three 200 mg capsules) taken twice daily orally, every 12 hours, within 30 minutes after a full meal of moderate or high fat (approximately 25 g of fat) for 14 days

Drug: Tecovirimat

Placebo

PLACEBO COMPARATOR

Identical placebo supplied by SIGA Technologies Inc.

Drug: Placebo

Interventions

Tecovirimat DRUG

600 mg po BID

Also known as: TPOXX

Tecovirimat

Placebo DRUG

identical placebo 600 mg po BID

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any sex, ≥ 18 years of age inclusive at the time of signing informed consent.
• Weight ≥ 40 kg
• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marina Klein: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• University Health Network, Toronto: collaborator
• Unity Health Toronto: collaborator
• University of British Columbia: collaborator
• CIHR Canadian HIV Trials Network: collaborator

Study Sites (3)

St. Paul's Hospital, BC Centre for Excellence in HIV/AIDS

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Mpox, Monkeypox

Interventions

tecovirimat

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine McGill University Health Centre, Research Director, MI4 Clinical Research Platform and Chronic Viral Illness Service, National Co-Director, CIHR Canadian HIV Trials Network

Model Details: Randomized 1:1

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 9, 2022
• Study Start: August 14, 2023
• Primary Completion: March 13, 2025
• Study Completion: March 31, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

CA (3)