Trial · NCT04388826

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

NCT04388826, Phase 2, Completed, Veru Inc.; results first posted 2021-11-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. COVID-19 Treatment of Severe Acute Respiratory Syndrome With Veru-111. Trials, record NCT04388826. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04388826

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: COVID-19 Treatment of Severe Acute Respiratory Syndrome With Veru-111
NCT number: NCT04388826
Status: Completed
Phases: Phase 2
Enrollment: 39 participants, actual
Lead sponsor: Veru Inc.
Conditions: Respiratory Distress Syndrome, Adult
Interventions: Veru-111
First posted: 2020-05-14
Last updated: 2022-10-27
Results first posted: 2021-11-24

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects That Are Alive Without Respiratory Failure at Day 29.	Day 29	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
Secondary	World Health Organization Ordinal Scale Clinical Improvement	Day 29	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
Secondary	Proportion of Subjects With Fever Normalization and SPO2 Greater Than 94% by Visit	Day 15, Day 22 and Day 29	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.
Secondary	Proportion of Subjects Alive and Discharged From Hospital by Visit	Day 15, Day 22 and Day 29	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).
Secondary	Patients Alive and Free of Respiratory Failure	Day 15 and Day 22	Proportion of patients alive and free or respiratory failure

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects That Are Alive Without Respiratory Failure at Day 29.	Day 29	Responders	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	World Health Organization Ordinal Scale Clinical Improvement	Day 29	World Health Organization Ordinal Scale for clinical improvement (Eight Point Ordinal Scale)-With Last Observation Carried Forward Values	Units on WHO COVID Scale	MEAN
SECONDARY	Proportion of Subjects With Fever Normalization and SPO2 Greater Than 94% by Visit	Day 15, Day 22 and Day 29	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Subjects Alive and Discharged From Hospital by Visit	Day 15, Day 22 and Day 29	Responders - subjects who are alive and have been discharged from the hospital at the time of the visit.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Patients Alive and Free of Respiratory Failure	Day 15 and Day 22	Responders	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Subjects That Are Alive Without Respiratory Failure at Day 29.	Veru-111 18 mg		17		Participants
Number of Subjects That Are Alive Without Respiratory Failure at Day 29.	Placebo		14		Participants
World Health Organization Ordinal Scale Clinical Improvement	Veru-111 18 mg		-1.7	Standard Deviation 1.49	Units on WHO COVID Scale
World Health Organization Ordinal Scale Clinical Improvement	Placebo		-1.1	Standard Deviation 2.42	Units on WHO COVID Scale
Proportion of Subjects With Fever Normalization and SPO2 Greater Than 94% by Visit	Veru-111 18 mg QD	Day 15	14		Participants
Proportion of Subjects With Fever Normalization and SPO2 Greater Than 94% by Visit	Placebo QD	Day 15	12		Participants
Proportion of Subjects With Fever Normalization and SPO2 Greater Than 94% by Visit	Veru-111 18 mg QD	Day 22	17		Participants
Proportion of Subjects With Fever Normalization and SPO2 Greater Than 94% by Visit	Placebo QD	Day 22	16		Participants
Proportion of Subjects With Fever Normalization and SPO2 Greater Than 94% by Visit	Veru-111 18 mg QD	Day 29	17		Participants
Proportion of Subjects With Fever Normalization and SPO2 Greater Than 94% by Visit	Placebo QD	Day 29	14		Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Veru-111 18 mg QD	19
Overall Study	STARTED	Placebo QD	20
Overall Study	COMPLETED	Veru-111 18 mg QD	15
Overall Study	COMPLETED	Placebo QD	18
Overall Study	NOT COMPLETED	Veru-111 18 mg QD	4
Overall Study	NOT COMPLETED	Placebo QD	2

Source ClinicalTrials.gov

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	Veru-111 18 mg	5	19	5
other	Constipation	Gastrointestinal disorders	Placebo	2	20	2
other	Septic Shock	Infections and infestations	Veru-111 18 mg	1	19	1
other	Septic Shock	Infections and infestations	Placebo	3	20	3
other	Alanine aminotransferase increased	Investigations	Veru-111 18 mg	2	19	2
other	Alanine aminotransferase increased	Investigations	Placebo	2	20	2
other	Aspartate aminotransferase increased	Investigations	Veru-111 18 mg	3	19	3
other	Aspartate aminotransferase increased	Investigations	Placebo	1	20	1
other	Acute Kidney Injury	Renal and urinary disorders	Veru-111 18 mg	0	19	0
other	Acute Kidney Injury	Renal and urinary disorders	Placebo	2	20	2

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Veru-111 18 mg	1	19
Total, all-cause mortality	Placebo	5	20
Total, other adverse events	Veru-111 18 mg	12	19
Total, other adverse events	Placebo	12	20
Total, serious adverse events	Veru-111 18 mg	3	19
Total, serious adverse events	Placebo	5	20

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Veru-111 18 mg vs Placebo: Number of Subjects That Are Alive Without Respiratory Failure at Day 29.	Trial comparisons
Veru-111 18 mg vs Placebo: deaths from any cause	Trial comparisons
Veru-111 18 mg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04388826

GET https://conductscience.org/api/trials/v1/NCT04388826/events?page=2

API reference For AI assistants