Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure
Primary Purpose
Smallpox, Monkeypox
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Tecovirimat
Sponsored by
About this trial
This is an expanded access trial for Smallpox
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02080767
First Posted
March 4, 2014
Last Updated
July 20, 2022
Sponsor
U.S. Army Medical Research and Development Command
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
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Primary Completion Date
undefined (undefined)
Study Completion Date
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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
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