VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study (VERU-111)
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|ClinicalTrials.gov Identifier: NCT04842747|
Recruitment Status : Completed
First Posted : April 13, 2021
Last Update Posted : August 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV Infection||Drug: VERU-111||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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. Subjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||The study will be a randomized, double-blind, placebo-controlled study. Randomization will be stratified by baseline WHO Ordinal Scale score of 4,5 and 6 such that subjects with a WHO Ordinal Scale of 4, 5 and 6 at screening are approximately equally distributed between the treatment groups. An emergency code break will be available to the investigator / pharmacist / investigational drug storage manager. This code break option in IWRS may only be disclosed in emergency situations when the identity of the trial drug must be known to the investigator in order to provide appropriate medical treatment or if required to assure safety of trial participants. If the code break for a patient is opened, the sponsor and CRO will be informed immediately via IWRS notification. The reason for the IWRS unblinding of the subject must be documented on the appropriate eCRF page along with the date and the initials of the person who broke the code.|
|Official Title:||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).|
|Actual Study Start Date :||May 18, 2021|
|Actual Primary Completion Date :||July 6, 2022|
|Actual Study Completion Date :||July 6, 2022|
Experimental: 9mg of VERU-111 Oral daily
9mg of VERU-111
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.
Other Name: Sabizabulin
No Intervention: Placebo Capsule once daily
Subjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital.
- VERU-111 in the treatment of SARS-Cov-2 Infection [ Time Frame: Day 60 ]VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of patients who die on study.
- To determine the percentage of subjects that are alive without respiratory failure at various intervals. [ Time Frame: Day 29 ]The proportion of subjects that are alive without respiratory failure at Day 15, Day 22 and Day 29. Day 29 is the key secondary end point in this study. Respiratory failure is defined as endotracheal intubation and mechanical ventilation, extracorporeal membrane oxygenation, high-flow nasal cannula oxygen delivery, noninvasive positive pressure ventilation, clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision making is driven solely by resource limitation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842747
|Study Chair:||Barnette||Veru Inc.|