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Tecovirimat Intravenous Treatment for Orthopox Virus Exposure

NCT05380752 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-03-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • SIGA Technologies

    collaborator INDUSTRY

  • U.S. Army Medical Research and Development Command

    lead FED

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05380752 on ClinicalTrials.gov