Trial Outcomes & Findings for VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study (NCT NCT04842747)

Last Updated: 2023-04-18

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

204 participants

Primary outcome timeframe

Day 60

Results posted on

2023-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	9mg of VERU-111 Oral Daily 9mg of VERU-111 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.	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.
Overall Study STARTED	134	70
Overall Study COMPLETED	125	66
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Reasons for withdrawal
Measure	9mg of VERU-111 Oral Daily 9mg of VERU-111 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.	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.
Overall Study Withdrawal by Subject	6	2
Overall Study Lost to Follow-up	1	2
Overall Study Physician Decision	1	0
Overall Study Subject refused all care decision was made to withdraw subject.No study IP given.IRB was consulted .	1	0

Baseline Characteristics

VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	9mg of VERU-111 Oral Daily n=134 Participants 9mg of VERU-111 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.	Placebo Capsule Once Daily n=70 Participants Subjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital.	Total n=204 Participants Total of all reporting groups
Age, Continuous	61.3 years STANDARD_DEVIATION 14.14 • n=99 Participants	62.7 years STANDARD_DEVIATION 13.90 • n=107 Participants	61.8 years STANDARD_DEVIATION 14.04 • n=206 Participants
Sex: Female, Male Female	44 Participants n=99 Participants	26 Participants n=107 Participants	70 Participants n=206 Participants
Sex: Female, Male Male	90 Participants n=99 Participants	44 Participants n=107 Participants	134 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	58 Participants n=99 Participants	28 Participants n=107 Participants	86 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=99 Participants	42 Participants n=107 Participants	118 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	6 Participants n=99 Participants	2 Participants n=107 Participants	8 Participants n=206 Participants
Race (NIH/OMB) White	114 Participants n=99 Participants	64 Participants n=107 Participants	178 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=99 Participants	2 Participants n=107 Participants	10 Participants n=206 Participants
Region of Enrollment North America	48 participants n=99 Participants	26 participants n=107 Participants	74 participants n=206 Participants
Region of Enrollment South America	55 participants n=99 Participants	27 participants n=107 Participants	82 participants n=206 Participants
Region of Enrollment Europe	31 participants n=99 Participants	17 participants n=107 Participants	48 participants n=206 Participants

PRIMARY outcome

Timeframe: Day 60

Population: Intent to treat population of 204

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).

Outcome measures

Outcome measures
Measure	9mg of VERU-111 Oral Daily n=134 Participants 9mg of VERU-111 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.	Placebo Capsule Once Daily n=70 Participants Subjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital.
Efficacy of Sabizabulin in the Treatment of SARS-CoV-2 Infection by Assessing Its Effect on the Proportion of Patients Who Died on Study.	25 Participants	27 Participants

SECONDARY outcome

Timeframe: Day 15, Day 22, Day 29

Population: Responders are subjects who are alive without respiratory failure at Day 15, Day 22 and Day 29.

The proportion of subjects that are alive without respiratory failure at Day 15, Day 22 and Day 29. 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.

Outcome measures

Outcome measures
Measure	9mg of VERU-111 Oral Daily n=134 Participants 9mg of VERU-111 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.	Placebo Capsule Once Daily n=70 Participants Subjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital.
The Proportion of Subjects That Are Alive Without Respiratory Failure at Day 15, Day 22 and Day 29. Day 15	94 Participants	40 Participants
The Proportion of Subjects That Are Alive Without Respiratory Failure at Day 15, Day 22 and Day 29. Day 22	96 Participants	39 Participants
The Proportion of Subjects That Are Alive Without Respiratory Failure at Day 15, Day 22 and Day 29. Day 29	96 Participants	38 Participants

Adverse Events

9mg of VERU-111 Oral Daily

Serious events: 38 serious events

Other events: 82 other events

Deaths: 25 deaths

Placebo Capsule Once Daily

Serious events: 32 serious events

Other events: 54 other events

Deaths: 27 deaths

Serious adverse events

Other adverse events

Additional Information

Gary Barnette PhD CSO

Veru

Phone: 800-606-9382

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	9mg of VERU-111 Oral Daily n=130 participants at risk 9mg of VERU-111 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.	Placebo Capsule Once Daily n=69 participants at risk Subjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital.
Blood and lymphatic system disorders Anemia	5.4% 7/130 • Number of events 7 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	4.3% 3/69 • Number of events 3 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Cardiac disorders Atrial fibrillation	4.6% 6/130 • Number of events 6 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	7.2% 5/69 • Number of events 5 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Cardiac disorders Bradycardia	4.6% 6/130 • Number of events 7 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	7.2% 5/69 • Number of events 5 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Gastrointestinal disorders Constipation	6.9% 9/130 • Number of events 9 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	8.7% 6/69 • Number of events 10 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Infections and infestations Pneumonia	6.2% 8/130 • Number of events 12 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	13.0% 9/69 • Number of events 12 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Infections and infestations Septic shock	1.5% 2/130 • Number of events 2 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	7.2% 5/69 • Number of events 5 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Infections and infestations Urinary tract infection	6.2% 8/130 • Number of events 8 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	1.4% 1/69 • Number of events 1 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Metabolism and nutrition disorders Hyperkalemia	4.6% 6/130 • Number of events 6 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	8.7% 6/69 • Number of events 7 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Metabolism and nutrition disorders Hypernatremia	4.6% 6/130 • Number of events 6 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	5.8% 4/69 • Number of events 4 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Metabolism and nutrition disorders Hypokalemia	4.6% 6/130 • Number of events 7 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	7.2% 5/69 • Number of events 7 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Metabolism and nutrition disorders Hypophosphatemia	1.5% 2/130 • Number of events 3 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	5.8% 4/69 • Number of events 5 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Psychiatric disorders Anxiety	3.1% 4/130 • Number of events 5 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	5.8% 4/69 • Number of events 4 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Psychiatric disorders Delirium	3.8% 5/130 • Number of events 5 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	5.8% 4/69 • Number of events 4 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Renal and urinary disorders Acute kidney injury	8.5% 11/130 • Number of events 11 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	11.6% 8/69 • Number of events 8 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	5.4% 7/130 • Number of events 7 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	4.3% 3/69 • Number of events 3 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.3% 3/130 • Number of events 4 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	5.8% 4/69 • Number of events 4 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.77% 1/130 • Number of events 1 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	10.1% 7/69 • Number of events 7 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Respiratory, thoracic and mediastinal disorders Respiratory failure	10.0% 13/130 • Number of events 14 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	20.3% 14/69 • Number of events 14 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.
Vascular disorders Hypotension	3.8% 5/130 • Number of events 9 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.	11.6% 8/69 • Number of events 8 • 60 Days Per protocol adverse events were captured from first dose thru day 60, resulting in this analysis to be the safety population of 199.