Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure

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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

Brief Summary

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



Study Type

Expanded Access




Condition

Smallpox

Intervention

Tecovirimat


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug





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.
      

Gender

All

Ages

N/A - N/A


Contacts

, 301-619-9904, [email protected]



Administrative Informations


NCT ID

NCT02080767

Organization ID

M-10331

Secondary IDs

S-11-10

Responsible Party

Sponsor

Study Sponsor

U.S. Army Medical Research and Development Command


Study Sponsor

, , 


Verification Date

February 2021