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Tecovirimat in Non-hospitalized Patients With Monkeypox (PLATINUM-CAN)

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ClinicalTrials.gov Identifier: NCT05534165
Recruitment Status : Not yet recruiting
First Posted : September 9, 2022
Last Update Posted : September 9, 2022
Sponsor:
Collaborators:
McGill University Health Centre/Research Institute of the McGill University Health Centre
University Health Network, Toronto
Unity Health Toronto
University of British Columbia
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
Marina Klein, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Condition or disease Intervention/treatment Phase
Monkeypox Drug: Tecovirimat Drug: Placebo Phase 3

Detailed Description:

In order to generate needed therapeutic efficacy evidence rapidly, international collaboration is essential. PLATINUM-CAN is a parallel collaborative trial linked with the sister trial PLATINUM led by Oxford University. Given the rapidly evolving epidemic and important differences in healthcare contexts and public health systems between countries that could impact the number of cases and access to diagnosis and treatment, a Canadian study is warranted to assess the feasibility and acceptability of conducting large scale interventional monkeypox trials in Canada. Such a focused trial also allows for the opportunity to explore a number of secondary objectives that can address concerns raised during consultation with Canadian community members (e.g., resolution of pain, quality of life) and validate use of self-assessed primary outcomes using blinded photography assessment.

The trial is pragmatic and minimizes number of visits, tests performed and contacts with the healthcare system through use of self-assessment diaries and self-testing. Lesion and/or throat swabs taken as part of standard care will be sent for detection of monkeypox virus DNA by PCR to local public health/provincial laboratories for initial screening (using panorthopox DNA testing) and confirmation with monkeypox specific PCR either locally or by National Microbiology Laboratory. The protocol allows for a broad range of patients to be enrolled. The trial has been designed so that it can accommodate patients who may be assessed in a variety of medical settings (e.g., hospital emergency rooms, outpatient HIV and infectious diseases clinics, community sexual health clinics, primary care, or through public health services). Similarly, we will ensure our trial design is able to contribute to global efforts such as the core protocol for the evaluation of treatments for human monkeypox (led by the Institut National de Recherche Biomédicale (INRB)/ANRS/NIAID in collaboration with WHO) and the AIDS Clinical Trials Group (ACTG) STOMP protocol.

As a feasibility study, PLATINUM CAN is underpowered for evaluating a primary endpoint of time to active lesion resolution. To achieve full study power, results will be combined with the sister study, PLATINUM-UK (n=500), being conducted at Oxford University, UK of similar design using a pre-planned individual patient meta-analysis. In addition to feasibility outcomes, the trial will evaluate the correlation between the time to active and complete resolution of lesions between self-report and blinded photographic validation from an adjudication committee, in consenting participants.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 1:1
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Identical placebo
Primary Purpose: Treatment
Official Title: Placebo-controlled Randomized Trial of Tecovirimat in Non-hospitalized Patients With Monkeypox: Canadian Feasibility Study (PLATINUM-CAN)
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mpox
Drug Information available for: Tecovirimat

Arm Intervention/treatment
Experimental: Tecovirimat
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
600 mg po BID
Other Name: TPOXX

Placebo Comparator: Placebo
Identical placebo supplied by SIGA Technologies Inc.
Drug: Placebo
identical placebo 600 mg po BID




Primary Outcome Measures :
  1. Time to active lesion resolution [ Time Frame: Up to 28 days after randomization ]
    Time (days) to active lesion resolution, defined as the first day on which all skin lesions are scabbed or desquamated (and mucosal lesions healed).

  2. Feasibility and acceptability of conducting a pragmatic phase 3 interventional trial for outpatients with Monkeypox in Canada [ Time Frame: 4 months ]
    Number of eligible patients per month and proportion randomized


Secondary Outcome Measures :
  1. Time to complete lesion resolution [ Time Frame: Up to 28 days after randomization ]
    Time (days) 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)

  2. Time to negative throat swab viral culture [ Time Frame: Days 7, 14, 21, and 28 ]
    Defined as time to consistently negative culture for monkeypox virus on throat swab

  3. Time to negative skin or mucosa swab viral culture [ Time Frame: Days 7, 14, 21, and 28 ]
    Defined as time to consistently negative culture for monkeypox virus on swab of most recent active skin or mucosa

  4. Secondary feasibility outcomes [ Time Frame: 4 months ]
    the proportion who adhere to at least 85% of daily questionnaires and self-sampling, and the proportion of participants who are able to complete all protocol procedures


Other Outcome Measures:
  1. Clinical status [ Time Frame: day 7, 14, 21 and 28 ]
    The ordinal scale is a) all lesions completely resolved (all scabs dropped off and intact skin remains underneath, mucosal lesions healed), b) all active lesions resolved (all lesions scabbed or desquamated, mucosal lesions healed), c) active lesions persist but no new lesions, d) new active lesions.

  2. Throat swab monkeypox DNA levels [ Time Frame: day 7, 14, 21 and 28 ]
    Change from baseline in monkeypox virus DNA concentration in throat swabs

  3. Hospitalization rates [ Time Frame: study duration ]
    Number (%) of patients admitted to hospital for a complication of monkeypox, overall and by type

  4. Time to sustained absence of use of analgesia [ Time Frame: Up to 28 days post randomization ]
    defined as time to consistently reporting no use of analgesia

  5. Assessment of safety [ Time Frame: Duration of study ]
    1. Number (%) of patients suffering serious adverse events (overall and by type) up to 28 days of randomization
    2. Number (%) of patients suffering adverse events of special interest (overall and by type) up to 28 days of randomization
    3. Number (%) of patients suffering death, overall and by cause

  6. Time to resolution of pain [ Time Frame: 28 days ]
    Time to resolution of pain using an assessment for proctitis (rectal) and/or lesional pain comparing tecovirimat relative to placebo

  7. Rate of improvement in overall quality of well-being [ Time Frame: 28 days ]
    Change in EuroQol- 5 Dimension (EQ-5D) Quality Of Life scale

  8. Validation of self reported time to active lesion resolution [ Time Frame: 28 days ]
    Correlation between the time to active and complete resolution of lesions, in consenting participants, between self-report and blinded photographic validation from an adjudication committee



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05534165


Contacts
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Contact: Hansi Peiris 514-934-1934 ext 37766 hansi.peiris@muhc.mcgill.ca
Contact: Karene Proulx-Boucher 514-934-1934 ext 37761 karene.proulx-boucher@muhc.mcgill.ca

Sponsors and Collaborators
Marina Klein
McGill University Health Centre/Research Institute of the McGill University Health Centre
University Health Network, Toronto
Unity Health Toronto
University of British Columbia
CIHR Canadian HIV Trials Network
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Responsible Party: Marina Klein, 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, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT05534165    
Other Study ID Numbers: CTN 338
First Posted: September 9, 2022    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marina Klein, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Tecovirimat
Randomized
Placebo-Controlled
Outpatients
Non-hospitalized
Feasibility
Additional relevant MeSH terms:
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Monkeypox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Infections