Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT02080767
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.
Sex:
ALL
Study:
NCT02080767
Study Brief:
Protocol Section:
NCT02080767