NO_LONGER_AVAILABLENot Applicable

Tecovirimat Intravenous Treatment for Orthopox Virus Exposure

Plain-language summary

* To provide a therapeutic option for patients not able to take the oral formulation of TPOXX (e.g., cannot swallow, vomiting) and who have confirmed or suspected (based on clinical signs and symptoms with known exposure while laboratory confirmation may be pending) orthopox virus infections OR who have a significant vaccinia adverse reaction (as defined in the protocol) resulting from vaccinia vaccination, secondary transmission, or other exposure; * To collect data on the safety of TPOXX IV (tecovirimat injection, 10 mg/mL).

Who can participate

SexALL

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Inclusion criteria

✓. Have a confirmed or suspected (based on clinical signs and symptoms with known or suspected exposure and/or positive or pending laboratory confirmation) orthopox virus infection.
✓. Be DoD-affiliated personnel (including active and reserve component service members, US civilian employees, contractors, other US personnel, and dependents, as well as allied military forces and local nationals) who have been granted access to the medical facility;
✓. Unable to take the oral formulation of TPOXX (e.g., unable to swallow capsules or take medication powder dissolved in soft food or liquid, vomiting);
✓. Is available for clinical follow-up for duration of the treatment and follow-up period;
✓. Females of childbearing potential must use a highly effective method of contraception during treatment and for 30 days after the last dose of drug. Male patients with a female partner of childbearing potential must use an acceptable method of contraception and refrain from donating sperm during treatment and for 30 days after the last dose.

Exclusion criteria

✕. Hypersensitivity to tecovirimat;
✕. Unable or unwilling to cooperate with the requirements of the protocol;
✕. Breastfeeding women: Nursing mothers will be counseled that tecovirimat has not been studied in breast-feeding women. Women who choose to continue breastfeeding will not be enrolled in this protocol. However, if a patient elects to stop breastfeeding for the duration of the study until 30 days after the last dose of the TPOXX IV, she may be enrolled.

Trial details

NCT IDNCT05380752

SponsorU.S. Army Medical Research and Development Command

Sponsor typeFED

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Orthopox Virus Infection trials