NCT05380752

Tecovirimat Intravenous Treatment for Orthopox Virus Exposure

EXPANDED ACCESS PROTOCOL FOR TREATMENT OF INDIVIDUALS FOLLOWING EXPOSURE TO ORTHOPOX VIRUSES WITH TPOXX IV (TECOVIRIMAT INJECTION, 10 mg/mL)

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: —
• Healthy volunteers: —

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).

Conditions

• Orthopox Virus Infection

Interventions

Type	Name	Description
DRUG	TPOXX IV (Tecovirimat Injection, 10 mg/mL)	IV solution (10 mg/mL) must be diluted with 2 parts 0.9% normal saline or 5% dextrose solution prior to dosing. Once diluted, the drug product should be stored at 2-8°C (36-46°F) and used as soon as possible (i.e., not more than 24 hours after dilution). Given via an IV infusion pump over a 6 hour period, twice daily, and for up to 7 days, or until the physician determines oral TPOXX may be given

Timeline

• First posted: 2022-05-19
• Last updated: 2025-03-10