search
Back to results

Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure

Primary Purpose

Smallpox, Monkeypox

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Tecovirimat
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 Smallpox

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • DoD-affiliated personnel (including US civilian employees, contractors and other US personnel and dependents, as well as allied military forces and local nationals) of any age, not breastfeeding
  • Has been exposed to or infected with orthopox viruses (ie, variola (smallpox), vaccinia, monkeypox, or cowpox) OR Has developed serious complications from vaccinia vaccination (eg, 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
  • Is available for clinical follow-up for duration of the treatment and follow-up period
  • Must be able to swallow capsules

Exclusion Criteria:

  • Has hypersensitivity to tecovirimat
  • Unable or unwilling to cooperate with the requirements of the treatment protocol
  • Breast-feeding patients. Note that breast-feeding females will be counseled that tecovirimat has not been studied in breast-feeding women and may opt to cease breast-feeding for the duration of the treatment and at least 30 days after the last dose of drug and thus be eligible for enrollment. Women who choose to continue breast-feeding will not be enrolled in this treatment protocol.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 4, 2014
    Last Updated
    July 20, 2022
    Sponsor
    U.S. Army Medical Research and Development Command
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02080767
    Brief Title
    Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure
    Official Title
    Clinical Protocol to Treat Individuals With Tecovirimat (ST-246) After Exposure to Orthopox Viruses
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    July 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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure to orthopox viruses.
    Detailed Description
    Rationale: Tecovirimat (TPOXX) is approved by FDA for treatment of smallpox. However, the therapeutic human dose for treatment of orthopox virus infections or a significant adverse reaction to vaccinia resulting from vaccination, secondary transmission, or other exposure, has not yet been fully established. Treatment: Based on the interpretation of currently available animal efficacy and human safety and PK data, the proposed human adult or pediatric patient (≥ 40 kg) therapeutic regimen is 600 mg (3 capsules of 200 mg) orally twice daily (BID) for at least 14 days, taken 30 minutes after a meal consisting of about 600 calories and 30% (25 grams) fat, which is the same as treatment for smallpox. If a dose is missed it should be taken as soon as possible unless it is near the next dose time. Doses should not be doubled in the event of a missed dose. Treatment may be extended beyond 14 days, with sponsor approval, if the investigator deems necessary. Nonclinical safety data support use for up to 90 days. The pediatric dosing recommendation is derived from the TPOXX package insert based on the body weight: 200 mg twice daily for patients of 13-25kg (29-45pounds); 400 mg twice daily for patients 25-40kg (55-87pounds) and 600 mg twice daily for pediatric patients over 40kg (88pounds) Clinical Evaluation: Medical history and concomitant medications will be recorded, and a physical examination with vital signs [eg, body weight, blood pressure, heart rate, respiratory rate, temperature, and height (only once)] will be completed. Photographs of affected areas, should lesions develop, may be taken. Patients will be followed for at least 30 days after receiving the last tecovirimat dose or until their infection improves.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Smallpox, Monkeypox

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Tecovirimat
    Other Intervention Name(s)
    ST 246
    Intervention Description
    Oral tablet 600mg daily dose(three capsules, 200 mg/capsule)

    10. Eligibility

    Sex
    All
    Eligibility Criteria
    Inclusion Criteria: DoD-affiliated personnel (including US civilian employees, contractors and other US personnel and dependents, as well as allied military forces and local nationals) of any age, not breastfeeding Has been exposed to or infected with orthopox viruses (ie, variola (smallpox), vaccinia, monkeypox, or cowpox) OR Has developed serious complications from vaccinia vaccination (eg, 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 Is available for clinical follow-up for duration of the treatment and follow-up period Must be able to swallow capsules Exclusion Criteria: Has hypersensitivity to tecovirimat Unable or unwilling to cooperate with the requirements of the treatment protocol Breast-feeding patients. Note that breast-feeding females will be counseled that tecovirimat has not been studied in breast-feeding women and may opt to cease breast-feeding for the duration of the treatment and at least 30 days after the last dose of drug and thus be eligible for enrollment. Women who choose to continue breast-feeding will not be enrolled in this treatment protocol.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Frances K Devlin
    Phone
    301-619-9904
    Email
    frances.k.devlin.ctr@mail.mil
    First Name & Middle Initial & Last Name or Official Title & Degree
    James W Karaszkiewicz, PhD
    Phone
    301-619-6809
    Email
    James.W.Karaszkiewicz.ctr@mail.mil

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36263798
    Citation
    Hatmal MM, Al-Hatamleh MAI, Olaimat AN, Ahmad S, Hasan H, Ahmad Suhaimi NA, Albakri KA, Abedalbaset Alzyoud A, Kadir R, Mohamud R. Comprehensive literature review of monkeypox. Emerg Microbes Infect. 2022 Dec;11(1):2600-2631. doi: 10.1080/22221751.2022.2132882.
    Results Reference
    derived

    Learn more about this trial

    Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure

    We'll reach out to this number within 24 hrs