European Trial Into Mpox Infection (EPOXI)

November 27, 2023 updated by: Miquel Ekkelenkamp

European Randomised Clinical Trial on mPOX Infection

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tecovirimat
Oral treatment with tecovirimat 200 mg capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).
Drug: Tecovirimat Oral Capsule
600 mg, twice daily, 14 days.
Other Names:
  • Tpoxx Tecovirimat
Placebo Comparator: Placebo
Matching placebo to tecovirimat capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).
Drug: Placebo
3 capsules, twice daily, 14 days.
Other Names:
  • Oral placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete mpox lesion resolution
Time Frame: 28 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to active lesion resolution
Time Frame: 28 days
The first day on which all skin lesions are scabbed or desquamated (and mucosal lesions healed), counted from start of therapy, with follow-up up to 28 days after randomisation
28 days
Status of the lesions on day 7, 14 and 28
Time Frame: Day 7, day 14 and day 28
Status of the lesions on day 7, 14, 21 and 28 according to an ordinal scale. The ordinal scale is a) all lesions completely resolved (all scabs dropped off and intact skin remains underneath, and all mucosal lesions healed), b) active lesions resolved (all skin lesions scabbed or desquamated, but not fully resolved), c) active lesions persist but no new lesions in last 24 hours, d) new lesion(s) in last 24 hours.
Day 7, day 14 and day 28
Time to resolution of symptoms
Time Frame: 90 days
Time to resolution of symptoms. Symptoms are counted from start of therapy and assessed by self-assessment. These include fatigue, malaise, nausea, vomiting, abdominal pain, anorexia, cough, dysphagia, odynophagia, fever, headache, oral pain, pain with urination, rectal/anal pain. Signs will be evaluated at study visits only, including lymphadenopathy and proctitis, and are not included in the evaluation of symptoms.
90 days
Occurrence of a negative monkeypox PCR of skin or mucosal swab
Time Frame: Days 7, 14 and 28
Negative monkeypox PCR (Polymerase Chain Reaction) of skin or mucosal swab, assessed for the two most active skin lesions or for the mucosal lesion.
Days 7, 14 and 28
Persistence of scars and skin discoloration
Time Frame: Assessed on day 90
Assessment of scars and/or skin discoloration of mpox lesions.
Assessed on day 90
Change from baseline in quality of life
Time Frame: Assessed on day 14 and day 90.

Change from baseline of quality of life, assessed by the Dermatology Life Quality Index (DLQI).

Minimum value = 0, maximum value = 30, a higher score indicates a worse outcome. (Ten questions with each a minimum of 0 and a maximum of 3.)
Assessed on day 14 and day 90.
All-cause mortality
Time Frame: Assessed on day 28 and on day 90
All-cause mortality
Assessed on day 28 and on day 90
Time to complication or all-cause admission to hospital or all-cause death
Time Frame: Assessed within 28 days and within 90 days.
Time to complication or all-cause admission to hospital or all-cause death, within 28 days and within 90 days, applicable to outpatients only, and counted from start of therapy. A complication includes genitourinary complications (e.g. urinary retention, paraphimosis), lower respiratory tract complication (e.g. pneumonia and need for oxygen), ocular impairment (e.g. keratitis), neurologic impairment (e.g. encephalitis) or mental health disturbance (e.g. confusion), cardiac impairment (e.g. cardiomyopathy or myocarditis), severe dehydration needing admission, secondary bacterial skin infection or severe pain needing hospital admission.
Assessed within 28 days and within 90 days.
Frequency of AEs, SAEs and SUSARs
Time Frame: Assessed within 28 days and within 90 days.
Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reaction (SUSARs) for the specific therapeutic, within the first 28 days, but also assessed during the total follow-up (up to day 90).
Assessed within 28 days and within 90 days.
Resolution of pain
Time Frame: Assessed on days 7, 14 and 90.

Resolution of pain, by measuring:

  1. time to resolution of pain assessed by the Numeric Rating Scale (NRS) for pain,
  2. time to cessation of the use of analgesic medication, defined as time to consistently reporting no use of analgesia for mpox-related lesions, up to 90 days after randomisation.
  3. anal pain on days 7, 14, and 90 assessed by the Health Related Symptom Index.
Assessed on days 7, 14 and 90.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miquel Ekkelenkamp

Collaborators

Erasmus Medical Center
Universiteit Antwerpen
European Clinical Research Alliance for Infectious Diseases (ECRAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Estimated)

December 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-501979-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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