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Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease
Sponsor: ANRS, Emerging Infectious Diseases
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.
Official title: 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
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
480
Start Date
2023-03-03
Completion Date
2026-11
Last Updated
2025-04-15
Healthy Volunteers
No
Interventions
Tecovirimat
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.
Placebo
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)
Fundación Huésped
Buenos Aires, Argentina
Faculty of Medicine, Federal University of Minas Gerais
Belo Horizonte, Brazil
Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation-FIOCRUZ
Rio de Janeiro, Brazil
Federal Hospital for State Employees
Rio de Janeiro, Brazil
Nova Iguaçu General Hospital
Rio de Janeiro, Brazil
University Hospital Prof. Edgard Santos
Salvador, Brazil
Emílio Ribas Institute of Infectious Diseases
São Paulo, Brazil
STD/AIDS Reference and Training Center
São Paulo, Brazil
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, Switzerland
Pr Alexandra Calmy
Geneva, Canton of Geneva, Switzerland
CHUV
Lausanne, Canton of Vaud, Switzerland
Zürich checkpoint
Zurich, Canton of Zurich, Switzerland