Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure
Plain-language summary
The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure to orthopox viruses.
Who can participate
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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.
Trial details
NCT IDNCT02080767
SponsorU.S. Army Medical Research and Development Command