search
Back to results

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

Primary Purpose

Monkeypox

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tecovirimat
Placebo
Sponsored by
Marina Klein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Monkeypox focused on measuring Tecovirimat, Randomized, Placebo-Controlled, Outpatients, Non-hospitalized, Feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Tecovirimat

    Placebo

    Arm Description

    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

    Identical placebo supplied by SIGA Technologies Inc.

    Outcomes

    Primary Outcome Measures

    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).
    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

    Secondary Outcome Measures

    Time to complete lesion resolution
    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)
    Time to negative throat swab viral culture
    Defined as time to consistently negative culture for monkeypox virus on throat swab
    Time to negative skin or mucosa swab viral culture
    Defined as time to consistently negative culture for monkeypox virus on swab of most recent active skin or mucosa
    Secondary feasibility outcomes
    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

    Full Information

    First Posted
    September 2, 2022
    Last Updated
    September 7, 2022
    Sponsor
    Marina Klein
    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
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05534165
    Brief Title
    Tecovirimat in Non-hospitalized Patients With Monkeypox
    Acronym
    PLATINUM-CAN
    Official Title
    Placebo-controlled Randomized Trial of Tecovirimat in Non-hospitalized Patients With Monkeypox: Canadian Feasibility Study (PLATINUM-CAN)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    January 2023 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Marina Klein
    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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Monkeypox
    Keywords
    Tecovirimat, Randomized, Placebo-Controlled, Outpatients, Non-hospitalized, Feasibility

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized 1:1
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Identical placebo
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tecovirimat
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Identical placebo supplied by SIGA Technologies Inc.
    Intervention Type
    Drug
    Intervention Name(s)
    Tecovirimat
    Other Intervention Name(s)
    TPOXX
    Intervention Description
    600 mg po BID
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    identical placebo 600 mg po BID
    Primary Outcome Measure Information:
    Title
    Time to active lesion resolution
    Description
    Time (days) to active lesion resolution, defined as the first day on which all skin lesions are scabbed or desquamated (and mucosal lesions healed).
    Time Frame
    Up to 28 days after randomization
    Title
    Feasibility and acceptability of conducting a pragmatic phase 3 interventional trial for outpatients with Monkeypox in Canada
    Description
    Number of eligible patients per month and proportion randomized
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Time to complete lesion resolution
    Description
    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)
    Time Frame
    Up to 28 days after randomization
    Title
    Time to negative throat swab viral culture
    Description
    Defined as time to consistently negative culture for monkeypox virus on throat swab
    Time Frame
    Days 7, 14, 21, and 28
    Title
    Time to negative skin or mucosa swab viral culture
    Description
    Defined as time to consistently negative culture for monkeypox virus on swab of most recent active skin or mucosa
    Time Frame
    Days 7, 14, 21, and 28
    Title
    Secondary feasibility outcomes
    Description
    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
    Time Frame
    4 months
    Other Pre-specified Outcome Measures:
    Title
    Clinical status
    Description
    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.
    Time Frame
    day 7, 14, 21 and 28
    Title
    Throat swab monkeypox DNA levels
    Description
    Change from baseline in monkeypox virus DNA concentration in throat swabs
    Time Frame
    day 7, 14, 21 and 28
    Title
    Hospitalization rates
    Description
    Number (%) of patients admitted to hospital for a complication of monkeypox, overall and by type
    Time Frame
    study duration
    Title
    Time to sustained absence of use of analgesia
    Description
    defined as time to consistently reporting no use of analgesia
    Time Frame
    Up to 28 days post randomization
    Title
    Assessment of safety
    Description
    Number (%) of patients suffering serious adverse events (overall and by type) up to 28 days of randomization Number (%) of patients suffering adverse events of special interest (overall and by type) up to 28 days of randomization Number (%) of patients suffering death, overall and by cause
    Time Frame
    Duration of study
    Title
    Time to resolution of pain
    Description
    Time to resolution of pain using an assessment for proctitis (rectal) and/or lesional pain comparing tecovirimat relative to placebo
    Time Frame
    28 days
    Title
    Rate of improvement in overall quality of well-being
    Description
    Change in EuroQol- 5 Dimension (EQ-5D) Quality Of Life scale
    Time Frame
    28 days
    Title
    Validation of self reported time to active lesion resolution
    Description
    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
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 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. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hansi Peiris
    Phone
    514-934-1934
    Ext
    37766
    Email
    hansi.peiris@muhc.mcgill.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karene Proulx-Boucher
    Phone
    514-934-1934
    Ext
    37761
    Email
    karene.proulx-boucher@muhc.mcgill.ca

    12. IPD Sharing Statement

    Learn more about this trial

    Tecovirimat in Non-hospitalized Patients With Monkeypox

    We'll reach out to this number within 24 hrs