At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 204 enrolled
Drug / intervention
VERU-111drug
Likely dose
VERU-111 9mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3, Randomized, Placebo-Controlled, Efficacy and Safety Study of VERU-111 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS).
In Brief
A Phase 3 clinical trial evaluating VERU-111 for SARS-CoV Infection. Completed, enrolled 204 participants across 58 sites in 6 countries.
Detailed Summary
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV Infection
CountriesArgentina, Brazil, Bulgaria, Colombia, Mexico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedApr 2021
Enrollment StartMay 2021
Primary CompletionJul 2022
TodayJul 2026
First PostedApr 13, 2021
Enrollment StartMay 18, 2021
Primary CompletionJul 6, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.2 years ago
Interventions
VERU-111drug
Subjects in the VERU-111 treatment groups will receive standard of care, plus oral daily VERU-111 9mg for 21 days or until released from hospital.