Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure

NCT02080767 | Unknown

• 2 other identifiers: M-10331S-11-10
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure to orthopox viruses.

Conditions

Smallpox; Monkeypox

Interventions

Tecovirimat DRUG

Oral tablet 600mg daily dose(three capsules, 200 mg/capsule)

Also known as: ST 246

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• DoD-affiliated personnel (including US civilian employees, contractors and other US personnel and dependents, as well as allied military forces and local nationals) of any age, not breastfeeding
• Has been exposed to or infected with orthopox viruses (ie, variola (smallpox), vaccinia, monkeypox, or cowpox) OR Has developed serious complications from vaccinia vaccination (eg, eczema vaccinatum, progressive vaccinia, generalized vaccinia that is severe or persistent, and select cases of inadvertent inoculation due to severe pain related to mucosal involvement, ocular involvement) resulting from vaccination, secondary transmission, or other exposure
• Is available for clinical follow-up for duration of the treatment and follow-up period
• Must be able to swallow capsules

You may not qualify if:

• Has hypersensitivity to tecovirimat
• Unable or unwilling to cooperate with the requirements of the treatment protocol
• Breast-feeding patients. Note that breast-feeding females will be counseled that tecovirimat has not been studied in breast-feeding women and may opt to cease breast-feeding for the duration of the treatment and at least 30 days after the last dose of drug and thus be eligible for enrollment. Women who choose to continue breast-feeding will not be enrolled in this treatment protocol.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead

Related Publications (1)

• Hatmal MM, Al-Hatamleh MAI, Olaimat AN, Ahmad S, Hasan H, Ahmad Suhaimi NA, Albakri KA, Abedalbaset Alzyoud A, Kadir R, Mohamud R. Comprehensive literature review of monkeypox. Emerg Microbes Infect. 2022 Dec;11(1):2600-2631. doi: 10.1080/22221751.2022.2132882.

  PMID: 36263798 DERIVED

MeSH Terms

Conditions

Smallpox; Mpox, Monkeypox

Interventions

tecovirimat

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Central Study Contacts

Frances K Devlin

CONTACT

301-619-9904; frances.k.devlin.ctr@mail.mil

James W Karaszkiewicz, PhD

CONTACT

301-619-6809; James.W.Karaszkiewicz.ctr@mail.mil

Study Design

• Study Type: expanded access
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Last Updated: March 6, 2025

Record last verified: 2025-03