Phase 4, Observational Field Study in Patients Treated With TPOXX for Smallpox Disease
Phase 4, Observational Field Study to evaluate safety and clinical benefit of TPOXX (tecovirimat) in patients treated with TPOXX following exposure to variola virus and a clinical diagnosis of smallpox disease.
Study Type
OBSERVATIONAL
TPOXX 600 mg (three 200 mg.) capsules twice daily for 14 days
Investigator Site
Corvallis, Oregon, United States
Assess survival
To assess the overall survival at Day 44 following treatment with TPOXX
Time frame: 44 days post first dose of TPOXX
Survival status
Survival status after completion of 14 days of TPOXX treatment will be assessed by physician for inpatients and collected from patient via patient diary question or follow up telephone contact.
Time frame: 14 days post first dose of TPOXX
Time to death
Time to death after treatment with TPOXX
Time frame: From date of treatment with TPOXX until the date of death from any cause, whichever came first, assessed up to 44 days after TPOXX treatment
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