Evaluating tecovirimat for treating monkeypox

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

This study is testing if an antiviral medicine called tecovirimat can help adults and teens with monkeypox heal faster and stay safe.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: ANRS, Emerging Infectious Diseases (Government)
• Locations: 12 sites (Buenos Aires and 11 other locations)
• Trial ID: NCT05597735 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of tecovirimat, an antiviral medication, in treating monkeypox in adults and adolescents aged 14 and older. Participants will receive either tecovirimat combined with standard care or a placebo with standard care, with the primary goal of measuring the time to resolution of visible lesions. Secondary objectives include evaluating mortality rates, hospitalization, complications, symptom duration, and virological shedding. The trial is a collaboration between Switzerland and Brazil, adapting a WHO core protocol to address public health needs effectively.

Who should consider this trial

Good fit: Ideal candidates include adults and adolescents (14 years and older) with confirmed or highly suspected monkeypox infection and at least one visible lesion.

Not a fit: Patients currently receiving other investigational drugs or those with hypersensitivity to tecovirimat may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective antiviral treatment for monkeypox, potentially reducing the severity and duration of the disease.

How similar studies have performed: Other studies have shown promise in using antivirals for similar viral infections, but this specific approach for monkeypox is relatively novel.

Eligibility criteria

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

Where this trial is running

Buenos Aires and 11 other locations

• Fundación Huésped — Buenos Aires, Argentina (Recruiting)
• Faculty of Medicine, Federal University of Minas Gerais — Belo Horizonte, Brazil (Recruiting)
• Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation-FIOCRUZ — Rio de Janeiro, Brazil (Recruiting)
• Federal Hospital for State Employees — Rio de Janeiro, Brazil (Recruiting)
• Nova Iguaçu General Hospital — Rio de Janeiro, Brazil (Recruiting)
• University Hospital Prof. Edgard Santos — Salvador, Brazil (Not_yet_recruiting)
• Emílio Ribas Institute of Infectious Diseases — São Paulo, Brazil (Not_yet_recruiting)
• STD/AIDS Reference and Training Center — São Paulo, Brazil (Recruiting)
• Hôpitaux Universitaires de Genève — Geneva, Canton of Geneva, Switzerland (Recruiting)
• Pr Alexandra Calmy — Geneva, Canton of Geneva, Switzerland (Recruiting)
• Chuv — Lausanne, Canton of Vaud, Switzerland (Not_yet_recruiting)
• Zürich checkpoint — Zurich, Canton of Zurich, Switzerland (Recruiting)

Study contacts

• Study coordinator: Michele GENIN, PhD

Conditions Monkeypox; Mpox; Tecovirimat; Antiviral agent