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

Withdrawn before enrolling

Conditions studied: Smallpox

In brief

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

Key facts

Study ID

NCT03972111

Run by

SIGA Technologies

People needed

0

Starts

2020-01-01

Expected to finish

2024-09-30

Last updated by the study team

2022-10-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known allergy to tecovirimat and/or excipients of TPOXX.

Where it is running

• Investigator Site — Corvallis, Oregon, United States

Full record on ClinicalTrials.gov

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