Smallpox
Conditions
Brief summary
Phase 4, Observational Field Study in Patients Treated With TPOXX for Smallpox Disease
Detailed description
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.
Interventions
DRUGTPOXX 200Mg Capsule
TPOXX 600 mg (three 200 mg.) capsules twice daily for 14 days
Sponsors
SIGA Technologies
Biomedical Advanced Research and Development Authority
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Able to provide informed consent or assent themselves or through a guardian or legally authorized representative, receiving or initiating treatment with TPOXX, and willing and able to adhere to the recommended procedures in the protocol. * Determined, per the clinical definition of smallpox, that the patient presenting with a case of acute, generalized vesicular/pustular rash meets Centers for Disease Control and Prevention (CDC) criteria of having confirmed, suspected, or probable smallpox and/or is at high or moderate risk for developing smallpox. * The CDC in coordination with the Department of Health and Human Services/Assistant Secretary for Preparedness and Response (ASPR) has released TPOXX to the physician or designated health authorities for patient treatment, and the CDC has provided physician contact information to PPD, the contract research organization.
Exclusion criteria
• Known allergy to tecovirimat and/or excipients of TPOXX.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess survival | 44 days post first dose of TPOXX | To assess the overall survival at Day 44 following treatment with TPOXX |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival status | 14 days post first dose of TPOXX | 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 to death | 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 | Time to death after treatment with TPOXX |
Countries
United States
Contacts
STUDY_DIRECTORDennis E. Hruby, PhD
SIGA Technologies
Outcome results
None listed