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VERU-111 for Coronavirus (VERU-111 Trial)

Phase 3
Waitlist Available
Research Sponsored by Veru Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15, day 22, day 29
Awards & highlights

VERU-111 Trial Summary

This study is evaluating whether a drug may help treat severe acute respiratory syndrome (SARS).

Eligible Conditions
  • Coronavirus

VERU-111 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15, day 22, day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15, day 22, day 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of Sabizabulin in the Treatment of SARS-CoV-2 Infection by Assessing Its Effect on the Proportion of Patients Who Died on Study.
Secondary outcome measures
The Proportion of Subjects That Are Alive Without Respiratory Failure at Day 15, Day 22 and Day 29.

Side effects data

From 2022 Phase 3 trial • 204 Patients • NCT04842747
10%
Respiratory failure
8%
Acute kidney injury
7%
Constipation
6%
Urinary tract infection
6%
Pneumonia
5%
Bradycardia
5%
Atrial fibrillation
5%
Hyperkalemia
5%
Hypernatremia
5%
Anemia
5%
Hypokalemia
5%
Acute respiratory failure
4%
Hypotension
4%
Delirium
3%
Sepsis
3%
Anxiety
3%
COVID-19
2%
Hypoxia
2%
Urinary tract infection bacterial
2%
Hypophosphatemia
2%
Pulmonary sepsis
2%
Cardio-respiratory arrest
2%
Septic shock
2%
Pulmonary embolism
2%
Sepsis Shock
2%
Severe acute respiratory syndrome
1%
Coma
1%
Death
1%
Procedural failure
1%
Dyspnoea
1%
Mydriasis
1%
Post procedural haemorrhage
1%
Pneumothorax
1%
Infection
1%
Urosepsis
1%
Clostridium difficile colitis
1%
Endocarditis staphylococcal
1%
Enterococcal sepsis
1%
Pneumonia acinetobacter
1%
Stroke in evolution
1%
Shock
1%
Acinetobacter infection
1%
Burkholderia cepacia complex infection
1%
Device related infection
1%
Cerebrovascular accident
1%
Polyneuropathy
1%
Seizure like phenomena
1%
Renal failure
1%
Laryngeal stenosis
1%
Arterial thrombosis
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
9mg of VERU-111 Oral Daily
Placebo Capsule Once Daily

VERU-111 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 9mg of VERU-111 Oral dailyExperimental Treatment1 Intervention
9mg of VERU-111
Group II: Placebo Capsule once dailyActive Control1 Intervention
Subjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VERU-111
2021
Completed Phase 3
~210

Find a Location

Who is running the clinical trial?

Veru Inc.Lead Sponsor
10 Previous Clinical Trials
488 Total Patients Enrolled
BarnetteStudy ChairVeru Inc.
9 Previous Clinical Trials
464 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study
2021. "VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04842747.
~52 spots leftby Apr 2025
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