Clinical Trial

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

Study acronym: UNITY
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2022-10-27; most recent amendment 2026-05-21.
Status change: Recruiting → Active, Not Recruiting 2026-05-21
Status change: Not Yet Recruiting → Recruiting 2023-06-19
Trial Details
NCT Number NCT05597735
Lead Sponsor ANRS, Emerging Infectious Diseases
Collaborators: University Hospital, Geneva, Oswaldo Cruz Foundation, Fundacion Huesped, Buenos Aires, Argentina
Conditions Monkeypox, Mpox
Enrollment 480 participants
Start Date 2023-03-03
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-26