European Trial Into Mpox Infection

ConditionMonkeypox

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorMiquel Ekkelenkamp

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: TecovirimatActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

28 days

Secondary outcomes

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

Time frame

28 days

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.

Time frame

Day 7, day 14 and day 28

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.

Time frame

90 days

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.

Time frame

Days 7, 14 and 28