European Trial Into Mpox Infection
ConditionMonkeypox
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMiquel Ekkelenkamp
About this trial
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
Qualifiers
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
Disqualifiers
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 design
Treatments tested in this trial
- Tecovirimat Oral Capsule
- Placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Miquel Ekkelenkamp
Lead sponsor
UMC Utrecht
Sponsor institution
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Collaborator
Erasmus Medical Center
Collaborator
Hospital Universitario La Paz
Collaborator
ANRS, Emerging Infectious Diseases
Collaborator
Universiteit Antwerpen
Collaborator
Source ClinicalTrials.gov