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EPOXI: European Trial Into Mpox Infection

Sponsor
Miquel Ekkelenkamp (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06156566
Collaborator
European Clinical Research Alliance for Infectious Diseases (ECRAID) (Other), Universiteit Antwerpen (Other), Erasmus Medical Center (Other)
150
Enrollment
2
Arms
48
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tecovirimat Oral Capsule
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The trial is controlled with matching placebo. Unblinding after database lock.
Primary Purpose:
Treatment
Official Title:
European Randomised Clinical Trial on mPOX Infection
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to complete mpox lesion resolution [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.

    Secondary Outcome Measures

    1. Time to active lesion resolution [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

    2. Status of the lesions on day 7, 14 and 28 [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.

    3. Time to resolution of symptoms [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.

    4. Occurrence of a negative monkeypox PCR of skin or mucosal swab [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.

    5. Persistence of scars and skin discoloration [Assessed on day 90]

      Assessment of scars and/or skin discoloration of mpox lesions.

    6. Change from baseline in quality of life [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.)

    7. All-cause mortality [Assessed on day 28 and on day 90]

      All-cause mortality

    8. Time to complication or all-cause admission to hospital or all-cause death [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.

    9. Frequency of AEs, SAEs and SUSARs [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).

    10. Resolution of pain [Assessed on days 7, 14 and 90.]

      Resolution of pain, by measuring: time to resolution of pain assessed by the Numeric Rating Scale (NRS) for pain, 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. anal pain on days 7, 14, and 90 assessed by the Health Related Symptom Index.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Miquel Ekkelenkamp, Clinical Microbiologist, UMC Utrecht
    ClinicalTrials.gov Identifier:
    NCT06156566
    Other Study ID Numbers:
    • 2022-501979-10
    First Posted:
    Dec 5, 2023
    Last Update Posted:
    Dec 5, 2023
    Last Verified:
    Nov 1, 2023
    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
    Keywords provided by Miquel Ekkelenkamp, Clinical Microbiologist, UMC Utrecht
    tecovirimat
    mpox
    TPOXX
    Additional relevant MeSH terms:
    Monkeypox
    Tecovirimat

    Study Results

    No Results Posted as of Dec 5, 2023