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

Smallpox Clinical Trial

Official title:

A Phase 4, Observational Field Study to Evaluate the Safety and Clinical Benefit of TPOXX (Tecovirimat)-Treated Patients Following Exposure to Variola Virus and Clinical Diagnosis of Smallpox Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03972111
• Other study ID #: SIGA-246-021
• Status: Withdrawn
• Start date: January 1, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2022
• Source: SIGA Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Phase 4, Observational Field Study in Patients Treated With TPOXX for Smallpox Disease

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Smallpox

Intervention

Drug:
• TPOXX 200Mg Capsule
TPOXX 600 mg (three 200 mg.) capsules twice daily for 14 days

Locations

Country	Name	City	State
United States	Investigator Site	Corvallis	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
SIGA Technologies	Biomedical Advanced Research and Development Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory objective-TPOXX plasma concentration	To evaluate the plasma concentration of TPOXX from any available samples	Plasma samples will be collected to determine the plasma concentration of TPOXX from Days 1-14 of the TPOXX treatment period for inpatients. This data will be reported.
Primary	Assess survival	To assess the overall survival at Day 44 following treatment with TPOXX	44 days post first dose of TPOXX
Secondary	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.	14 days post first dose of TPOXX
Secondary	Time to death	Time to death after treatment with TPOXX	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