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Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02080767
Expanded Access Status : Available
First Posted : March 6, 2014
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Brief Summary:
The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure to orthopox viruses.

Condition or disease Intervention/treatment
Smallpox Monkeypox Drug: Tecovirimat

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Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Clinical Protocol to Treat Individuals With Tecovirimat (ST-246) After Exposure to Orthopox Viruses



Intervention Details:
  • Drug: Tecovirimat
    Oral tablet 600mg daily dose(three capsules, 200 mg/capsule)
    Other Name: ST 246

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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): NCT02080767


Contacts
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Contact: Frances K Devlin 301-619-9904 frances.k.devlin.ctr@mail.mil
Contact: James W Karaszkiewicz, PhD 301-619-6809 James.W.Karaszkiewicz.ctr@mail.mil

Sponsors and Collaborators
U.S. Army Medical Research and Development Command
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Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT02080767    
Other Study ID Numbers: M-10331
S-11-10 ( Other Identifier: Sponsor )
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Smallpox
Monkeypox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Infections