A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox

Withdrawn

• Conditions: Smallpox

• Registration Number: NCT03972111
• Lead Sponsor: SIGA Technologies

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.

Study Timeline

• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Study Start: 2020-01-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-10-03
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess survival	44 days post first dose of TPOXX	To assess the overall survival at Day 44 following treatment with TPOXX

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Investigator Site; 🇺🇸 Corvallis, Oregon, United States