Actively Recruiting
Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease
Led by ANRS, Emerging Infectious Diseases · Updated on 2025-04-15
480
Participants Needed
12
Research Sites
191 weeks
Total Duration
On this page
Sponsors
A
ANRS, Emerging Infectious Diseases
Lead Sponsor
U
University Hospital, Geneva
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults and adolescents 14 years old and older with laboratory-confirmed or highly suspected monkeypox virus infection
- At least one visible active skin or mucosal lesion
- Reachable via smartphone for video calls if outpatient
- Signed informed consent
You will not qualify if you...
- Current or planned use of another investigational drug during the study
- Ongoing treatment that cannot be stopped and interacts significantly with tecovirimat
- Increased risk from study participation as judged by the investigator
- Known hypersensitivity to tecovirimat
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Fundación Huésped
Buenos Aires, Argentina, C1204ABB
Actively Recruiting
2
Faculty of Medicine, Federal University of Minas Gerais
Belo Horizonte, Brazil
Actively Recruiting
3
Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation-FIOCRUZ
Rio de Janeiro, Brazil
Actively Recruiting
4
Federal Hospital for State Employees
Rio de Janeiro, Brazil
Actively Recruiting
5
Nova Iguaçu General Hospital
Rio de Janeiro, Brazil
Actively Recruiting
6
University Hospital Prof. Edgard Santos
Salvador, Brazil
Not Yet Recruiting
7
Emílio Ribas Institute of Infectious Diseases
São Paulo, Brazil
Not Yet Recruiting
8
STD/AIDS Reference and Training Center
São Paulo, Brazil
Actively Recruiting
9
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, Switzerland, 1211
Actively Recruiting
10
Pr Alexandra Calmy
Geneva, Canton of Geneva, Switzerland, 1211
Actively Recruiting
11
CHUV
Lausanne, Canton of Vaud, Switzerland, 1010
Not Yet Recruiting
12
Zürich checkpoint
Zurich, Canton of Zurich, Switzerland
Actively Recruiting
Research Team
M
Michele GENIN, PhD
CONTACT
A
Alexandra Calmy, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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