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Tecovirimat Intravenous Treatment for Orthopox Virus Exposure (TPOXX IV)

Primary Purpose

Orthopox Virus Infection

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
TPOXX IV (Tecovirimat Injection, 10 mg/mL)
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Orthopox Virus Infection

Eligibility Criteria

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Inclusion Criteria:

  1. Have a confirmed or suspected (based on clinical signs and symptoms with known or suspected exposure and/or positive or pending laboratory confirmation) orthopox virus infection.

    Note: Patients with a negative orthopox virus diagnostic test but with epidemiological and clinical evidence of an orthopox viral infection, especially those with evidence of clinical disease progression, may be included. Primary/Treating physician may consult with sponsor's Subject Matter Expert; OR Have developed a significant vaccinia adverse reaction (e.g., eczema vaccinatum, progressive vaccinia, generalized vaccinia that is severe or persistent, and select cases of inadvertent inoculation due to severe pain related to mucosal involvement, ocular involvement) resulting from vaccination, secondary transmission, or other exposure;

  2. Be DoD-affiliated personnel (including active and reserve component service members, US civilian employees, contractors, other US personnel, and dependents, as well as allied military forces and local nationals) who have been granted access to the medical facility;
  3. Unable to take the oral formulation of TPOXX (e.g., unable to swallow capsules or take medication powder dissolved in soft food or liquid, vomiting);
  4. Is available for clinical follow-up for duration of the treatment and follow-up period;
  5. Females of childbearing potential must use a highly effective method of contraception during treatment and for 30 days after the last dose of drug. Male patients with a female partner of childbearing potential must use an acceptable method of contraception and refrain from donating sperm during treatment and for 30 days after the last dose.

Exclusion Criteria:

  1. Hypersensitivity to tecovirimat;
  2. Unable or unwilling to cooperate with the requirements of the protocol;
  3. Breastfeeding women: Nursing mothers will be counseled that tecovirimat has not been studied in breast-feeding women. Women who choose to continue breastfeeding will not be enrolled in this protocol. However, if a patient elects to stop breastfeeding for the duration of the study until 30 days after the last dose of the TPOXX IV, she may be enrolled.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 27, 2022
    Last Updated
    August 8, 2022
    Sponsor
    U.S. Army Medical Research and Development Command
    Collaborators
    SIGA Technologies
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05380752
    Brief Title
    Tecovirimat Intravenous Treatment for Orthopox Virus Exposure
    Acronym
    TPOXX IV
    Official Title
    EXPANDED ACCESS PROTOCOL FOR TREATMENT OF INDIVIDUALS FOLLOWING EXPOSURE TO ORTHOPOX VIRUSES WITH TPOXX IV (TECOVIRIMAT INJECTION, 10 mg/mL)
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    U.S. Army Medical Research and Development Command
    Collaborators
    SIGA Technologies

    4. Oversight

    5. Study Description

    Brief Summary
    To provide a therapeutic option for patients not able to take the oral formulation of TPOXX (e.g., cannot swallow, vomiting) and who have confirmed or suspected (based on clinical signs and symptoms with known exposure while laboratory confirmation may be pending) orthopox virus infections OR who have a significant vaccinia adverse reaction (as defined in the protocol) resulting from vaccinia vaccination, secondary transmission, or other exposure; To collect data on the safety of TPOXX IV (tecovirimat injection, 10 mg/mL).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Orthopox Virus Infection

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    TPOXX IV (Tecovirimat Injection, 10 mg/mL)
    Intervention Description
    IV solution (10 mg/mL) must be diluted with 2 parts 0.9% normal saline or 5% dextrose solution prior to dosing. Once diluted, the drug product should be stored at 2-8°C (36-46°F) and used as soon as possible (i.e., not more than 24 hours after dilution). Given via an IV infusion pump over a 6 hour period, twice daily, and for up to 7 days, or until the physician determines oral TPOXX may be given

    10. Eligibility

    Sex
    All
    Eligibility Criteria
    Inclusion Criteria: Have a confirmed or suspected (based on clinical signs and symptoms with known or suspected exposure and/or positive or pending laboratory confirmation) orthopox virus infection. Note: Patients with a negative orthopox virus diagnostic test but with epidemiological and clinical evidence of an orthopox viral infection, especially those with evidence of clinical disease progression, may be included. Primary/Treating physician may consult with sponsor's Subject Matter Expert; OR Have developed a significant vaccinia adverse reaction (e.g., eczema vaccinatum, progressive vaccinia, generalized vaccinia that is severe or persistent, and select cases of inadvertent inoculation due to severe pain related to mucosal involvement, ocular involvement) resulting from vaccination, secondary transmission, or other exposure; Be DoD-affiliated personnel (including active and reserve component service members, US civilian employees, contractors, other US personnel, and dependents, as well as allied military forces and local nationals) who have been granted access to the medical facility; Unable to take the oral formulation of TPOXX (e.g., unable to swallow capsules or take medication powder dissolved in soft food or liquid, vomiting); Is available for clinical follow-up for duration of the treatment and follow-up period; Females of childbearing potential must use a highly effective method of contraception during treatment and for 30 days after the last dose of drug. Male patients with a female partner of childbearing potential must use an acceptable method of contraception and refrain from donating sperm during treatment and for 30 days after the last dose. Exclusion Criteria: Hypersensitivity to tecovirimat; Unable or unwilling to cooperate with the requirements of the protocol; Breastfeeding women: Nursing mothers will be counseled that tecovirimat has not been studied in breast-feeding women. Women who choose to continue breastfeeding will not be enrolled in this protocol. However, if a patient elects to stop breastfeeding for the duration of the study until 30 days after the last dose of the TPOXX IV, she may be enrolled.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Force Health Protection
    Phone
    301-401-2768
    Email
    usarmy.detrick.medcom-usammda.mbx.force-health-protection@mail.mil

    12. IPD Sharing Statement

    Learn more about this trial

    Tecovirimat Intravenous Treatment for Orthopox Virus Exposure

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