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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Argentina
Fundación Huésped
RECRUITING
Buenos Aires
Brazil
Faculty of Medicine, Federal University of Minas Gerais
RECRUITING
Belo Horizonte
Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation-FIOCRUZ
RECRUITING
Rio De Janeiro
Federal Hospital for State Employees
RECRUITING
Rio De Janeiro
Nova Iguaçu General Hospital
RECRUITING
Rio De Janeiro
University Hospital Prof. Edgard Santos
NOT_YET_RECRUITING
Salvador
Emílio Ribas Institute of Infectious Diseases
NOT_YET_RECRUITING
São Paulo
STD/AIDS Reference and Training Center
RECRUITING
São Paulo
Switzerland
Hôpitaux Universitaires de Genève
RECRUITING
Geneva
Pr Alexandra Calmy
RECRUITING
Geneva
CHUV
NOT_YET_RECRUITING
Lausanne
Zürich checkpoint
RECRUITING
Zurich
Contact Information
Primary
Michele GENIN, PhD
michele.genin@inserm.fr
0182533538
Backup
Alexandra Calmy, Pr
alexandra.calmyl@hcuge.ch
0223729812
Time Frame
Start Date: 2023-03-03
Estimated Completion Date: 2026-11
Participants
Target number of participants: 480
Treatments
Experimental: Tecovirimat
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Collaborators: Oswaldo Cruz Foundation, University Hospital, Geneva, Fundacion Huesped, Buenos Aires, Argentina
Leads: ANRS, Emerging Infectious Diseases

This content was sourced from clinicaltrials.gov