European Randomised Clinical Trial on mPOX Infection
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Belgium
Institute of Tropical Medicine
RECRUITING
Antwerp
Cliniques Universitaires St. Luc
NOT_YET_RECRUITING
Brussels
France
APHP St. Louis
NOT_YET_RECRUITING
Paris
Germany
Universitätsklinikum Bonn
NOT_YET_RECRUITING
Bonn
Italy
Hospital Luigi Sacco
NOT_YET_RECRUITING
Milan
Azienda Ospedaliera Universitaria Integrata Verona - AOUI Verona
NOT_YET_RECRUITING
Verona
Netherlands
Amsterdam UMC - AMC
NOT_YET_RECRUITING
Amsterdam
Norway
Oslo Unversity Hospital
NOT_YET_RECRUITING
Oslo
Portugal
Hospital de Santo António dos Capuchos
NOT_YET_RECRUITING
Lisbon
Spain
Hospital Clinico San Carlos
NOT_YET_RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Virgen Macarena
NOT_YET_RECRUITING
Seville
Contact Information
Primary
Miquel B Ekkelenkamp, MD, PhD
m.ekkelenkamp@umcutrecht.nl
+31643217087
Backup
Lina Gurskaite
lina.gurskaite@ecraid.eu
+31631117890
Time Frame
Start Date: 2024-08-09
Estimated Completion Date: 2026-08
Participants
Target number of participants: 150
Treatments
Active_comparator: Tecovirimat
Oral treatment with tecovirimat 200 mg capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).
Placebo_comparator: Placebo
Matching placebo to tecovirimat capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).
Related Therapeutic Areas
Sponsors
Collaborators: European Clinical Research Alliance for Infectious Diseases (ECRAID), ANRS, Emerging Infectious Diseases, Hospital Universitario La Paz, Universiteit Antwerpen, Erasmus Medical Center
Leads: Miquel Ekkelenkamp