Use of Tecovirimat (TPOXX®) for Treatment of Human Orthopoxvirus Infections.
E
Emily Marie Gould
Primary Investigator
Overview
EXPANDED ACCESS IND: The purpose of this expanded access IND treatment program is to provide tecovirimat for primary or early empiric treatment of confirmed or suspected (based on clinical signs and symptoms with known exposure while laboratory confirmation may be pending) non-variola orthopoxvirus infections (e.g., vaccinia, monkeypox, cowpox or other human virus infection identified as an orthopoxvirus) and secondary treatment of complications from replicationcompetent vaccinia vaccine in adults and children.
Description
This program allows consideration of all patient populations, who meet eligibility criteria, to
receive tecovirimat treatment under this IND program (e.g., children and all adults including
pregnant and nursing women, and prisoners).
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
non-variola orthopoxyvirus
-
Age: - 100 Years
-
Gender: All
Inclusion Criteria:
- Primary or early empiric treatment: Patients are eligible for primary or early empiric treatment with tecovirimat under this protocol if they have non-variola orthopoxvirus infection confirmed by laboratory diagnostic testing or have suspected infection based on known exposure(s) and/or clinical manifestations of disease, while laboratory confirmation may be pending.
Exclusion Criteria:
- Known allergy to tecovirimat and/or excipients of tecovirimat
- • Upon negative laboratory results for orthopoxvirus in individuals whose tecovirimat treatment is initiated based on clinical manifestations of disease prior to laboratory results.
- • For IV tecovirimat only: patients with severe renal impairment (creatinine clearance <30 mL/min)
Updated on
02 May 2024.
Study ID: 15990, FAMM-CDC-TPOXX
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