Testing tecovirimat for treating mpox infection
European Randomised Clinical Trial on mPOX Infection
This study is testing if a medication called tecovirimat can help people with mpox feel better and recover safely compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 12 sites (Antwerp, Antwerp and 11 other locations) |
| Trial ID | NCT06156566 on ClinicalTrials.gov |
What this trial studies
This randomized controlled double-blind clinical trial aims to evaluate the effectiveness and safety of tecovirimat in patients diagnosed with mpox, previously known as monkeypox. Participants will be randomly assigned to receive either tecovirimat or a placebo, with the treatment regimen consisting of 600 mg of tecovirimat taken orally twice daily. The study will compare the outcomes of infection and any side effects experienced between the two groups to determine the drug's efficacy and safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a confirmed mpox infection and active skin or mucosal lesions.
Not a fit: Patients under 18 years of age, those weighing less than 40 kg, or those who are pregnant or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide an effective treatment option for patients suffering from mpox infection.
How similar studies have performed: While this approach is focused on tecovirimat for mpox, similar antiviral treatments have shown promise in other viral infections, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Antwerp, Antwerp and 11 other locations
- Institute of Tropical Medicine — Antwerp, Antwerp, Belgium (Recruiting)
- Cliniques Universitaires St. Luc — Brussels, Belgium (Not_yet_recruiting)
- APHP St. Louis — Paris, France (Not_yet_recruiting)
- Universitätsklinikum Bonn — Bonn, Germany (Not_yet_recruiting)
- Hospital Luigi Sacco — Milan, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Universitaria Integrata Verona - AOUI Verona — Verona, Italy (Not_yet_recruiting)
- Amsterdam UMC - AMC — Amsterdam, Netherlands (Not_yet_recruiting)
- Oslo Unversity Hospital — Oslo, Norway (Not_yet_recruiting)
- Hospital de Santo António dos Capuchos — Lisbon, Portugal (Not_yet_recruiting)
- Hospital Clinico San Carlos — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario La Paz — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario Virgen Macarena — Seville, Spain (Not_yet_recruiting)
Study contacts
- Principal investigator: Miquel B Ekkelenkamp, MD, PhD — UMC Utrecht
- Study coordinator: Miquel B Ekkelenkamp, MD, PhD
- Email: m.ekkelenkamp@umcutrecht.nl
- Phone: +31643217087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.