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Clinical Trials in Brazil / NCT05597735
Active, not recruiting Phase 3

Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease

NCT05597735 · tracked via the Priya Life Science Brazil tracker
Sponsor
ANRS, Emerging Infectious Diseases
Phase
Phase 3
Started
2023-03-03
Last updated
2026-05-26

Condition(s) studied

MonkeypoxMpox

Investigational drug(s) / intervention(s)

Tecovirimat →Placebo

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.

Study 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

Sex
ALL
Min age
14 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
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
Pr Alexandra Calmy Geneva Canton of Geneva
CHUV Lausanne Canton of Vaud
Zürich checkpoint Zurich Canton of Zurich

More ANRS, Emerging Infectious Diseases trials in Brazil

Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis Recruiting
DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection Recruiting

Other trials for the same condition

Observational, Prospective, Cohort Study of Mpox Infection in Brazil (NETPOX) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05597735 on ClinicalTrials.gov ↗ ← All trials in Brazil