European Trial Into Mpox Infection (EPOXI)

Miquel Ekkelenkamp

Status and phase: Enrolling; Phase 4

Conditions: Monkeypox

Treatments: Drug: Placebo; Drug: Tecovirimat Oral Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06156566

2022-501979-10

Details and patient eligibility

About

The goal of this randomized controlled double-blind clinical trial is to test the drug tecovirimat in patients with mpox (previously known as monkeypox) disease.

The main questions it aims to answer are:

• Is tecovirimat effective in treating mpox infection.
• Is tecovirimat safe to treat patients with mpox infection.

Participants will receive either the drug tecovirimat orally, 600 mg twice per day, or a matching placebo. The outcome of the infection and the side effect experienced will be compared between the two groups.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Polymerase Chain Reaction (PCR) /Nucleic Acid Amplification Test (NAAT) -confirmed mpox infection
• The presence of active skin or mucosal lesion(s)
• Signed Informed Consent Form

Exclusion criteria

• Age <18 years.
• Body weight <40 kg
• Pregnant and breastfeeding patients are not eligible for inclusion in this study.
• Lack of mental capacity to provide informed consent
• Trial participation is considered not in the best interest of patient
• Known hypersensitivity to the active substance or to any of the excipients of the study drug.
• Use of contraindicated treatment repaglinide. (Repaglinide, an oral treatment for diabetes mellitus, may be discontinued while taking study treatment with the agreement of the patient's general practitioner, who may start alternate diabetes treatment if considered necessary.)
• Previous, current or planned use of another investigational drug (tecovirimat) at any point during study participation.
• The patient's own doctor considers there to be a definite indication for the patient to receive tecovirimat or the local guidelines establish that tecovirimat treatment should be initiated
• The patient's own doctor considers there to be a definite contraindication to the patient receiving tecovirimat.
• The patient suffers from hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Tecovirimat

Active Comparator group

Description:

Oral treatment with tecovirimat 200 mg capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).

Treatment:

Drug: Tecovirimat Oral Capsule

Placebo

Placebo Comparator group

Description:

Matching placebo to tecovirimat capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).

Treatment:

Drug: Placebo