European Trial Into Mpox Infection

Last updated: March 24, 2025
Sponsor: Miquel Ekkelenkamp
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Tecovirimat Oral Capsule

Placebo

Clinical Study ID

NCT06156566
2022-501979-10
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Polymerase Chain Reaction (PCR) /Nucleic Acid Amplification Test (NAAT) -confirmedmpox infection

  • The presence of active skin or mucosal lesion(s)

  • Signed Informed Consent Form

Exclusion

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 thestudy drug.

  • Use of contraindicated treatment repaglinide. (Repaglinide, an oral treatment fordiabetes mellitus, may be discontinued while taking study treatment with theagreement of the patient's general practitioner, who may start alternate diabetestreatment if considered necessary.)

  • Previous, current or planned use of another investigational drug (tecovirimat) atany point during study participation.

  • The patient's own doctor considers there to be a definite indication for the patientto receive tecovirimat or the local guidelines establish that tecovirimat treatmentshould be initiated

  • The patient's own doctor considers there to be a definite contraindication to thepatient receiving tecovirimat.

  • The patient suffers from hereditary problems of galactose intolerance, Lapp lactasedeficiency or glucose-galactose malabsorption.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Tecovirimat Oral Capsule
Phase: 4
Study Start date:
August 09, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Institute of Tropical Medicine

    Antwerp, 2000
    Belgium

    Active - Recruiting

  • Cliniques Universitaires St. Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • APHP St. Louis

    Paris, 75010
    France

    Site Not Available

  • Universitätsklinikum Bonn

    Bonn, 53127
    Germany

    Site Not Available

  • Hospital Luigi Sacco

    Milan,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Integrata Verona - AOUI Verona

    Verona,
    Italy

    Site Not Available

  • Amsterdam UMC - AMC

    Amsterdam,
    Netherlands

    Site Not Available

  • Oslo Unversity Hospital

    Oslo, 0450
    Norway

    Site Not Available

  • Hospital de Santo António dos Capuchos

    Lisbon, 1169-050
    Portugal

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Site Not Available

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