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NCT Number: NCT03972111

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

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

Why the study stopped: commitment fulfilled
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Key information

Conditions

Smallpox DNA Virus Infections Infections Poxviridae Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigator Site

Corvallis, Oregon, 97333, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TPOXX 200Mg Capsule

Drug

TPOXX 600 mg (three 200 mg.) capsules twice daily for 14 days

Other names: tecovirimat

Primary outcomes

  1. Assess survival

    Time frame: 44 days post first dose of TPOXX

    To assess the overall survival at Day 44 following treatment with TPOXX

Secondary outcomes

  1. Survival status

    Time frame: 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.

  2. Time to death

    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

    Time to death after treatment with TPOXX

Other outcomes

  1. Exploratory objective-TPOXX plasma concentration

    Time frame: 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.

    To evaluate the plasma concentration of TPOXX from any available samples

Sponsors and collaborators

Lead sponsor

SIGA Technologies

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2019
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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