BridgeMD
New treatment option for Monkeypox
Official title European Trial Into Mpox Infection
ClinicalTrials.gov ID: NCT06156566
What this study is testing
What is Tecovirimat Oral Capsule?
Tecovirimat Oral Capsule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for monkeypox.
Also referred to as Tpoxx Tecovirimat.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Antwerp, Antwerp, Belgium
- Brussels, Belgium
- Paris, France
- Bonn, Germany
- Milan, Italy
- Verona, Italy
- Amsterdam, Netherlands
- Oslo, Norway
- Lisbon, Portugal
- Madrid, Spain
- Seville, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Antwerp, Antwerp, Belgium; Brussels, Belgium; Paris, France; Bonn, Germany; Milan, Italy; Verona, Italy and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.