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European Trial Into Mpox Infection

NCT06156566 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-03-28

No results posted yet for this study

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

  • Monkeypox

Interventions

DRUG

Tecovirimat Oral Capsule

600 mg, twice daily, 14 days.

DRUG

Placebo

3 capsules, twice daily, 14 days.

Sponsors & Collaborators

  • European Clinical Research Alliance for Infectious Diseases (ECRAID)

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Hospital Universitario La Paz

    collaborator OTHER

  • ANRS, Emerging Infectious Diseases

    collaborator OTHER_GOV

  • Universiteit Antwerpen

    collaborator OTHER

  • Miquel Ekkelenkamp

    lead OTHER

Principal Investigators

  • Miquel B Ekkelenkamp, MD, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-09
Primary Completion
2025-12-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06156566 on ClinicalTrials.gov