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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Smallpox

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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TPOXX 200Mg Capsule

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

Intervention Type DRUG

Other Intervention Names

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tecovirimat

Eligibility Criteria

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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.