Expanded Access IND Protocol: Use of Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections in Adults and Children
J
John Christenson, MD
Primary Investigator
Administratively Closed
100 years or below
All
Phase
N/A
1 participants needed
1 Location
Brief description of study
The purpose of this expanded access IND (compassionate use) program is to provide stockpiled tecovirimat for treatment of non-variola orthopoxvirus infections and secondary treatment of complications from replication-competent vaccinia vaccine in adults and children.
Detailed description of study
All patient populations, who meet eligibility criteria, can receive tecovirimat treatment under this IND program (e.g., children and all adults including pregnant and nursing individuals, and prisoners). Clinical considerations of tecovirimat therapy during an outbreak may evolve depending on the duration and nature of the outbreak and event-based information that may become available during the outbreak
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: orthoproxvirus, Riley
-
Age: 100 years or below
-
Gender: All
Inclusion Criteria:
Exclusion Criteria:
- Known allergy to tecovirimat and/or inactive ingredients in tecovirimat
- For IV tecovirimat only: patients with severe renal impairment (creatinine clearance <30 mL/min). Oral tecovirimat is an option for patients with severe renal impairment.
Updated on
28 Apr 2025.
Study ID: PINF-CDC-TPOXX-EAP, 16103
