RecruitingPhase 4NCT06156566

European Trial Into Mpox Infection

European Randomised Clinical Trial on mPOX Infection


Sponsor

Miquel Ekkelenkamp

Enrollment

150 participants

Start Date

Aug 9, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria11

  • 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.

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Interventions

DRUGTecovirimat Oral Capsule

600 mg, twice daily, 14 days.

DRUGPlacebo

3 capsules, twice daily, 14 days.


Locations(12)

Institute of Tropical Medicine

Antwerp, Antwerp, Belgium

Cliniques Universitaires St. Luc

Brussels, Belgium

APHP St. Louis

Paris, France

Universitätsklinikum Bonn

Bonn, Germany

Hospital Luigi Sacco

Milan, Italy

Azienda Ospedaliera Universitaria Integrata Verona - AOUI Verona

Verona, Italy

Amsterdam UMC - AMC

Amsterdam, Netherlands

Oslo Unversity Hospital

Oslo, Norway

Hospital de Santo António dos Capuchos

Lisbon, Portugal

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

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NCT06156566


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