Actively Recruiting
European Trial Into Mpox Infection
Led by Miquel Ekkelenkamp · Updated on 2025-03-28
150
Participants Needed
12
Research Sites
103 weeks
Total Duration
On this page
Sponsors
M
Miquel Ekkelenkamp
Lead Sponsor
E
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
European Trial Into Mpox Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Polymerase Chain Reaction (PCR) /Nucleic Acid Amplification Test (NAAT) -confirmed mpox infection
- Presence of active skin or mucosal lesion(s)
- Signed Informed Consent Form
You will not qualify if you...
- Age under 18 years
- Body weight under 40 kg
- Pregnant and breastfeeding patients
- Lack of mental capacity to provide informed consent
- Trial participation not in the best interest of patient
- Known hypersensitivity to the active substance or excipients of the study drug
- Use of contraindicated treatment repaglinide
- Previous, current or planned use of another investigational drug (tecovirimat) during study
- Doctor considers definite indication for tecovirimat treatment
- Doctor considers definite contraindication to tecovirimat
- Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Institute of Tropical Medicine
Antwerp, Antwerp, Belgium, 2000
Actively Recruiting
2
Cliniques Universitaires St. Luc
Brussels, Belgium, 1200
Not Yet Recruiting
3
APHP St. Louis
Paris, France, 75010
Not Yet Recruiting
4
Universitätsklinikum Bonn
Bonn, Germany, 53127
Not Yet Recruiting
5
Hospital Luigi Sacco
Milan, Italy
Not Yet Recruiting
6
Azienda Ospedaliera Universitaria Integrata Verona - AOUI Verona
Verona, Italy
Not Yet Recruiting
7
Amsterdam UMC - AMC
Amsterdam, Netherlands
Not Yet Recruiting
8
Oslo Unversity Hospital
Oslo, Norway, 0450
Not Yet Recruiting
9
Hospital de Santo António dos Capuchos
Lisbon, Portugal, 1169-050
Not Yet Recruiting
10
Hospital Clinico San Carlos
Madrid, Spain, 28040
Not Yet Recruiting
11
Hospital Universitario La Paz
Madrid, Spain, 28046
Not Yet Recruiting
12
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Not Yet Recruiting
Research Team
M
Miquel B Ekkelenkamp, MD, PhD
CONTACT
L
Lina Gurskaite
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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