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RECRUITING
NCT06156566
PHASE4

European Trial Into Mpox Infection

Sponsor: Miquel Ekkelenkamp

View on ClinicalTrials.gov

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.

Official title: European Randomised Clinical Trial on mPOX Infection

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-08-09

Completion Date

2026-08

Last Updated

2025-03-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tecovirimat Oral Capsule

600 mg, twice daily, 14 days.

DRUG

Placebo

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