Trial Outcomes & Findings for COVID-19 Treatment of Severe Acute Respiratory Syndrome With Veru-111 (NCT NCT04388826)

Last Updated: 2022-10-27

Results Overview

To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at 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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Day 29

Results posted on

2022-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Veru-111 18 mg QD Veru-111 18mg capsules Veru-111: Respiratory Distress Syndrome, Adult	Placebo QD Placebo capsules Veru-111: Respiratory Distress Syndrome, Adult
Overall Study STARTED	19	20
Overall Study COMPLETED	15	18
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Veru-111 18 mg QD Veru-111 18mg capsules Veru-111: Respiratory Distress Syndrome, Adult	Placebo QD Placebo capsules Veru-111: Respiratory Distress Syndrome, Adult
Overall Study Lost to Follow-up	3	2
Overall Study Adverse Event	1	0

Baseline Characteristics

COVID-19 Treatment of Severe Acute Respiratory Syndrome With Veru-111

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Number of Patients Exposed to Veru-111 18 mg n=19 Participants Veru-111 18mg capsules Veru-111: Respiratory Distress Syndrome, Adult	Number of Patients Exposed to Placebo n=20 Participants Placebo capsules Veru-111: Respiratory Distress Syndrome, Adult	Total n=39 Participants Total of all reporting groups
Age, Continuous	59.3 Years STANDARD_DEVIATION 11.40 • n=5 Participants	57.8 Years STANDARD_DEVIATION 13.32 • n=7 Participants	58.5 Years STANDARD_DEVIATION 12.28 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	17 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	20 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 29

Population: Responders

Outcome measures

Outcome measures
Measure	Veru-111 18 mg n=19 Participants Veru-111 18mg capsules Veru-111: Respiratory Distress Syndrome, Adult	Placebo n=20 Participants Placebo capsules Veru-111: Respiratory Distress Syndrome, Adult
Number of Subjects That Are Alive Without Respiratory Failure at Day 29.	17 Participants	14 Participants

SECONDARY outcome

Timeframe: Day 29

Population: World Health Organization Ordinal Scale for clinical improvement (Eight Point Ordinal Scale)-With Last Observation Carried Forward Values

Improvement on the World Health Organization Ordinal Scale for Clinical Improvement. 8-point ordinal scale (WHO scale from 0 to 8). Lower value equals better while higher value equals worse Score of 0 Uninfected No clinical or virologic evidence of infection Score of 1 Ambulatory No limitation of activities Score of 2 Limitation of activities Score of 3 Hospitalized, no oxygen therapy Score of 4 Oxygen by mask or nasal prongs Score of 5 Non-invasive ventilation or high-flow oxygen Score of 6 Intubation and mechanical ventilation Score of 7 Ventilation + additional organ support - pressors, RRT, ECMO Score of 8 Death

Outcome measures

Outcome measures
Measure	Veru-111 18 mg n=19 Participants Veru-111 18mg capsules Veru-111: Respiratory Distress Syndrome, Adult	Placebo n=20 Participants Placebo capsules Veru-111: Respiratory Distress Syndrome, Adult
World Health Organization Ordinal Scale Clinical Improvement	-1.7 Units on WHO COVID Scale Standard Deviation 1.49	-1.1 Units on WHO COVID Scale Standard Deviation 2.42

SECONDARY outcome

Timeframe: Day 15, Day 22 and Day 29

Population: Responders are subjects who have been discharged from the hospital or has fever normalization maintained for at least 24 hours AND peripheral capillary oxygen saturation (SPO2) greater than 94% sustained for 24 hours is observed at the time of the visit.

Proportion of subjects with normalization of fever and oxygen saturation through. Responders are subjects who have been discharged from the hospital or has fever normalization maintained for at least 24 hours AND peripheral capillary oxygen saturation (SPO2) greater than 94% sustained for 24 hours is observed at the time of the visit. Non-responders are subjects who died before the visit or do not meet both criteria of the end point at the time of the visit.

Outcome measures

Outcome measures
Measure	Veru-111 18 mg n=19 Participants Veru-111 18mg capsules Veru-111: Respiratory Distress Syndrome, Adult	Placebo n=20 Participants Placebo capsules Veru-111: Respiratory Distress Syndrome, Adult
Proportion of Subjects With Fever Normalization and SPO2 Greater Than 94% by Visit Day 15	14 Participants	12 Participants
Proportion of Subjects With Fever Normalization and SPO2 Greater Than 94% by Visit Day 22	17 Participants	16 Participants
Proportion of Subjects With Fever Normalization and SPO2 Greater Than 94% by Visit Day 29	17 Participants	14 Participants

SECONDARY outcome

Timeframe: Day 15, Day 22 and Day 29

Population: Responders - subjects who are alive and have been discharged from the hospital at the time of the visit.

Proportion of subjects alive and discharged from hospital by visit. Responders are subjects who are alive and have been discharged from the hospital at the time of the visit. (Non-responders are subjects who died before the visit or in the hospital at the time of the visit).

Outcome measures

Outcome measures
Measure	Veru-111 18 mg n=19 Participants Veru-111 18mg capsules Veru-111: Respiratory Distress Syndrome, Adult	Placebo n=20 Participants Placebo capsules Veru-111: Respiratory Distress Syndrome, Adult
Proportion of Subjects Alive and Discharged From Hospital by Visit Day 15	14 Participants	12 Participants
Proportion of Subjects Alive and Discharged From Hospital by Visit Day 22	17 Participants	15 Participants
Proportion of Subjects Alive and Discharged From Hospital by Visit Day 29	18 Participants	14 Participants

SECONDARY outcome

Timeframe: Day 15 and Day 22

Population: Responders

Proportion of patients alive and free or respiratory failure

Outcome measures

Outcome measures
Measure	Veru-111 18 mg n=19 Participants Veru-111 18mg capsules Veru-111: Respiratory Distress Syndrome, Adult	Placebo n=20 Participants Placebo capsules Veru-111: Respiratory Distress Syndrome, Adult
Patients Alive and Free of Respiratory Failure Day 15	16 Participants	13 Participants
Patients Alive and Free of Respiratory Failure Day 22	16 Participants	14 Participants

Adverse Events

Veru-111 18 mg

Serious events: 3 serious events

Other events: 12 other events

Deaths: 1 deaths

Placebo

Serious events: 5 serious events

Other events: 12 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Veru-111 18 mg n=19 participants at risk Veru-111 18mg capsules Veru-111: Respiratory Distress Syndrome, Adult	Placebo n=20 participants at risk Placebo capsules Veru-111: Respiratory Distress Syndrome, Adult
Cardiac disorders Cardiac Arrest	5.3% 1/19 • Number of events 1 • 62 Days	0.00% 0/20 • 62 Days
Infections and infestations Septic Sock	5.3% 1/19 • Number of events 1 • 62 Days	10.0% 2/20 • Number of events 2 • 62 Days
Nervous system disorders Encephalopathy	0.00% 0/19 • 62 Days	5.0% 1/20 • Number of events 1 • 62 Days
Renal and urinary disorders Acute Kidney Injury	0.00% 0/19 • 62 Days	5.0% 1/20 • Number of events 1 • 62 Days
Respiratory, thoracic and mediastinal disorders Epistaxis	5.3% 1/19 • Number of events 1 • 62 Days	0.00% 0/20 • 62 Days
Infections and infestations COVID-19	0.00% 0/19 • 62 Days	5.0% 1/20 • Number of events 1 • 62 Days

Other adverse events

Other adverse events
Measure	Veru-111 18 mg n=19 participants at risk Veru-111 18mg capsules Veru-111: Respiratory Distress Syndrome, Adult	Placebo n=20 participants at risk Placebo capsules Veru-111: Respiratory Distress Syndrome, Adult
Gastrointestinal disorders Constipation	26.3% 5/19 • Number of events 5 • 62 Days	10.0% 2/20 • Number of events 2 • 62 Days
Infections and infestations Septic Shock	5.3% 1/19 • Number of events 1 • 62 Days	15.0% 3/20 • Number of events 3 • 62 Days
Investigations Alanine aminotransferase increased	10.5% 2/19 • Number of events 2 • 62 Days	10.0% 2/20 • Number of events 2 • 62 Days
Investigations Aspartate aminotransferase increased	15.8% 3/19 • Number of events 3 • 62 Days	5.0% 1/20 • Number of events 1 • 62 Days
Renal and urinary disorders Acute Kidney Injury	0.00% 0/19 • 62 Days	10.0% 2/20 • Number of events 2 • 62 Days
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/19 • 62 Days	10.0% 2/20 • Number of events 2 • 62 Days
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.3% 1/19 • Number of events 1 • 62 Days	15.0% 3/20 • Number of events 4 • 62 Days
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/19 • 62 Days	20.0% 4/20 • Number of events 4 • 62 Days

Additional Information

Gary Barnette PhD CSO

Veru

Phone: 9194263611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place