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

NCT04388826 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: V0211901
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 5

Brief Summary

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 22. Respiratory failure is defined as non-invasive ventilation or high-flow oxygen, intubation and mechanical ventilation, or ventilation with additional organ support (e.g., pressors, RRT, ECMO).

Conditions

Respiratory Distress Syndrome, Adult

Outcome Measures

Primary Outcomes (1)

• Number of Subjects That Are Alive Without Respiratory Failure at 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

  Day 29

Secondary Outcomes (4)

• World Health Organization Ordinal Scale Clinical Improvement

  Day 29

• Proportion of Subjects With Fever Normalization and SPO2 Greater Than 94% by Visit

  Day 15, Day 22 and Day 29

• Proportion of Subjects Alive and Discharged From Hospital by Visit

  Day 15, Day 22 and Day 29

• Patients Alive and Free of Respiratory Failure

  Day 15 and Day 22

Study Arms (2)

Veru-111 18 mg

EXPERIMENTAL

Veru-111 18mg capsules

Drug: Veru-111

Placebo

PLACEBO COMPARATOR

Placebo capsules

Drug: Veru-111

Interventions

Veru-111 DRUG

Respiratory Distress Syndrome, Adult

Also known as: Bisindole

Placebo; Veru-111 18 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide informed consent
• Be able to communicate effectively with the study personnel
• Aged ≥18 years
• Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test
• Patients at high risk for ARDS, with known comorbidities for being at high risk, such as, Asthma (moderate to severe), Chronic Lung Disease, Diabetes, Chronic Kidney Disease being treated with dialysis, Severe Obesity (BMI ≥40), 65 years of age or older, primarily reside in a nursing home or long-term care facility, immunocompromised
• Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air at screening
• Subjects must agree to use acceptable methods of contraception
• If subject is female or the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository \[i.e., barrier method of contraception\], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)
• If female subject or the female partner of a male subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used
• If female subject or the female partner of a male subject has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used
• Subject is willing to comply with the requirements of the protocol through the end of the study

You may not qualify if:

• Known hypersensitivity or allergy to colchicine
• Participation in any other clinical trial of an experimental treatment for COVID-19
• Concurrent treatment with other experimental agents with actual or possible direct acting antiviral activity against COVID-19 is prohibited \< 24 hours prior to study drug dosing (except standard of care) Remdesivir and convalescent plasma is allowed as standard of care.
• Requiring mechanical ventilation at screening
• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 X upper limit of normal (ULN)
• Total bilirubin \> ULN
• Creatinine clearance \< 60 mL/min
• Documented medical history of liver disease, including but not limited to, prior diagnosis of hepatitis of any etiology, cirrhosis, portal hypertension, or confirmed or suspected esophageal varices
• Moderate to severe renal impairment
• Hepatic impairment
• Positive for HbsAg, or HCV antibodies at screening
• Any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
• Participants must agree to refrain from prolonged exposure to the sun or agree to use at least SPF 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with VERU-111.

Sponsors & Collaborators

• Veru Inc.: lead

Study Sites (5)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Methodist Hospital

Saint Louis Park, Minnesota, 55426, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Inspira Medical Center

Vineland, New Jersey, 08360, United States

Location

Memorial Hermann Memorial City Hospital

Houston, Texas, 77024, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

sabizabulin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Results Point of Contact

• Title: Gary Barnette PhD CSO
• Organization: Veru

gbarnette@verupharma.com

9194263611

Study Officials

• Barnette

  Veru Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind Randomized Placebo-Controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Placebo-Controlled

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 14, 2020
• Study Start: June 18, 2020
• Primary Completion: December 18, 2020
• Study Completion: August 13, 2021
• Last Updated: October 27, 2022
• Results First Posted: November 24, 2021

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)