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

SIGA Technologies

Status: Withdrawn

Conditions: Smallpox

Treatments: Drug: TPOXX 200Mg Capsule

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT03972111

SIGA-246-021

Details and patient eligibility

About

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

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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.