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

Study acronym: UNITY
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 26, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Sep 30, 2025 to Sep 30, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Nov 2026 to Sep 30, 2026
    • Site details revised at 12 of 12 sites
    v8
  2. Enrollment target: 150 to 480
    • Primary completion date: Mar 30, 2025 to Sep 30, 2025
    • Study completion date: Aug 1, 2026 to Nov 2026
    • Site details revised at 4 of 12 sites
    v7
  3. Lead sponsor: Calmy Alexandra to ANRS, Emerging Infectious Diseasesv6 Show 4 more changesShow less
    • Primary completion date: Jan 1, 2024 to Mar 30, 2025
    • Study sites: 11 to 12
    • Study completion date: Jan 1, 2025 to Aug 1, 2026
    • Collaborators: 2 to 3
  4. Study sites: 10 to 11v5
  5. Site details revised at 1 of 10 sitesv4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2022 to Mar 3, 2023
    • Study sites: 9 to 10
    v3
  2. Study description expanded, about 5 words
    • Study title shortened, about 4 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05597735
Lead Sponsor ANRS, Emerging Infectious Diseases
Collaborators: University Hospital, Geneva, Oswaldo Cruz Foundation, Fundacion Huesped, Buenos Aires, Argentina
Conditions
(from sponsor)		 Monkeypox, Mpox
Related terms Mpox, Monkeypox
Enrollment 480 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov