European Trial Into Mpox Infection

NCT06156566 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2022-501979-10
• Study Type: interventional
• Target: 150
• Locations: 8 countries
• Sites: 12

Brief 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

Keywords

tecovirimat; mpox; TPOXX

Outcome Measures

Primary Outcomes (1)

• Time to complete mpox lesion resolution

  Time in days until day 28 after randomization, until the first day on which all lesions are completely healed with a new fresh layer of skin.

  28 days

Secondary Outcomes (10)

• Time to active lesion resolution

  28 days

• Status of the lesions on day 7, 14 and 28

  Day 7, day 14 and day 28

• Time to resolution of symptoms

  90 days

• Occurrence of a negative monkeypox PCR of skin or mucosal swab

  Days 7, 14 and 28

• Persistence of scars and skin discoloration

  Assessed on day 90

Study Arms (2)

Tecovirimat

ACTIVE COMPARATOR

Oral treatment with tecovirimat 200 mg capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).

Drug: Tecovirimat Oral Capsule

Placebo

PLACEBO COMPARATOR

Matching placebo to tecovirimat capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).

Drug: Placebo

Interventions

Tecovirimat Oral Capsule DRUG

600 mg, twice daily, 14 days.

Also known as: Tpoxx Tecovirimat

Tecovirimat

Placebo DRUG

3 capsules, twice daily, 14 days.

Also known as: Oral placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify if:

• Age \<18 years.
• Body weight \<40 kg
• 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.

Sponsors & Collaborators

• Miquel Ekkelenkamp: lead
• 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

Study Sites (12)

Institute of Tropical Medicine

Antwerp, Antwerp, 2000, Belgium

RECRUITING

Cliniques Universitaires St. Luc

Brussels, 1200, Belgium

NOT YET RECRUITING

APHP St. Louis

Paris, 75010, France

NOT YET RECRUITING

Universitätsklinikum Bonn

Bonn, 53127, 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, 0450, Norway

NOT YET RECRUITING

Hospital de Santo António dos Capuchos

Lisbon, 1169-050, Portugal

NOT YET RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

NOT YET RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

NOT YET RECRUITING

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MeSH Terms

Conditions

Mpox, Monkeypox

Interventions

tecovirimat

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Officials

• Miquel B Ekkelenkamp, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miquel B Ekkelenkamp, MD, PhD

CONTACT

+31643217087; m.ekkelenkamp@umcutrecht.nl

Lina Gurskaite

CONTACT

+31631117890; lina.gurskaite@ecraid.eu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial is controlled with matching placebo. Unblinding after database lock.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Microbiologist

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: December 5, 2023
• Study Start: August 9, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2024-08

Locations

DE (1); ES (3); NO (1); NL (1); PT (1); BE (2); IT (2); FR (1)