Trials / Recruiting
RecruitingNCT06156566
European Trial Into Mpox Infection
European Randomised Clinical Trial on mPOX Infection
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Miquel Ekkelenkamp · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tecovirimat Oral Capsule | 600 mg, twice daily, 14 days. |
| DRUG | Placebo | 3 capsules, twice daily, 14 days. |
Timeline
- Start date
- 2024-08-09
- Primary completion
- 2025-12-01
- Completion
- 2026-08-01
- First posted
- 2023-12-05
- Last updated
- 2025-03-28
Locations
12 sites across 8 countries: Belgium, France, Germany, Italy, Netherlands, Norway, Portugal, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06156566. Inclusion in this directory is not an endorsement.