Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease
A Phase III, Multi-country, Randomized, Placebo-controlled, Double-blinded Trial to Assess the Efficacy and Safety of Tecovirimat Antiviral Treatment for Patients With Monkeypox Virus Disease
ANRS, Emerging Infectious Diseases
480 participants
Mar 3, 2023
INTERVENTIONAL
Conditions
Summary
The overall purpose of this study is to evaluate whether tecovirimat is an efficient and safe antiviral in the treatment of monkeypox in adults and adolescents (14 years old and older). The primary objective is to evaluate the clinical efficacy, as assessed by time to all visible lesion(s) resolution, of tecovirimat treatment + Standard of Care (SOC) compared to placebo + SOC for patients with monkeypox. The secondary objective is to evaluate the clinical efficacy, as assessed by mortality, hospitalization, complications, duration of symptoms and virological shedding, and the safety of tecovirimat treatment + SOC compared to placebo + SOC in patients with monkeypox.
Eligibility
Inclusion Criteria4
- Adults and adolescents (14 years old and older) with laboratory-confirmed (PCR if available) or highly suspected monkeypox virus infection of any duration
- At least one visible active skin or mucosal lesion
- Reachable via smartphone (for video calls) for outpatient participants
- Signed informed consent
Exclusion Criteria4
- Current or planned use of another investigational drug at any point during study participation.
- Ongoing treatment which cannot be interrupted and for which a major interaction has been described with tecovirimat
- Patients who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study (for example: if the investigator judges that an antiviral treatment is indicated in the framework of compassionate therapeutic access in Switzerland).
- Hypersensitivity to tecovirimat
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Interventions
The experimental intervention is tecovirimat, available as immediate-release capsules containing tecovirimat monohydrate, equivalent to 200 mg of tecovirimat. The route of administration of tecovirimat is oral. Tecovirimat treatment will be initiated as soon as possible after diagnosis. The international recommended doses will be followed: * 25 kg to less than 40 kg: 400 mg (two tecovirimat 200 mg capsules) every 12 hours for 14 consecutive days. * 40 kg and above: 600 mg (three tecovirimat 200 mg capsules) every 12 hours for 14 consecutive days.
The control intervention is a placebo and its route of administration will be identical to the experimental intervention administration to allow treatment arm blinding.
Locations(12)
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NCT05597735