European Trial Into Mpox Infection

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.

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

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.

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.

Negative monkeypox PCR (Polymerase Chain Reaction) of skin or mucosal swab, assessed for the two most active skin lesions or for the mucosal lesion.

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

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.)

All-cause mortality

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.

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).

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.