European Trial Into Mpox Infection

Monkeypox Clinical Trial

— EPOXI  

Official title:

European Randomised Clinical Trial on mPOX Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06156566
• Other study ID #: 2022-501979-10
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 2024
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: UMC Utrecht
• Contact: Miquel B Ekkelenkamp, MD, PhD
• Phone: +31643217087
• Email: m.ekkelenkamp[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Monkeypox

Intervention

Drug:
• Tecovirimat Oral Capsule
600 mg, twice daily, 14 days.
• Placebo
3 capsules, twice daily, 14 days.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Miquel Ekkelenkamp	Erasmus Medical Center, European Clinical Research Alliance for Infectious Diseases (ECRAID), Universiteit Antwerpen

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to active lesion resolution	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
Secondary	Status of the lesions on day 7, 14 and 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
Secondary	Time to resolution of symptoms	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
Secondary	Occurrence of a negative monkeypox PCR of skin or mucosal swab	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
Secondary	Persistence of scars and skin discoloration	Assessment of scars and/or skin discoloration of mpox lesions.	Assessed on day 90
Secondary	Change from baseline in quality of life	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.
Secondary	All-cause mortality	All-cause mortality	Assessed on day 28 and on day 90
Secondary	Time to complication or all-cause admission to hospital or all-cause death	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.
Secondary	Frequency of AEs, SAEs and SUSARs	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.
Secondary	Resolution of pain	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.	Assessed on days 7, 14 and 90.