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

March 24, 2023 updated by: Veru Inc.

Phase 3, Randomized, Placebo-Controlled, Efficacy and Safety Study of VERU-111 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS).

To demonstrate the 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multicenter, randomized, placebo-control, efficacy and safety study of VERU-111 for the treatment of COVID-19. Subjects will receive either 9mg of VERU-111 or matching placebo orally or through nasogastric tube daily for up to 21 days or until the subject is discharged from the hospital, whichever comes first. The primary efficacy endpoint of the study will be the proportion of subjects that die prior to Day 60.The total study duration for a subject from screening to follow up visit is planned to be 62 days. In addition to the safety of VERU-111, an evaluation of the efficacy of VERU-111 on SARS-CoV-2 (COVID-19) compared to the placebo control will be evaluated as part of the Independent Data Monitoring Committee (IDMC).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1814
        • Hospital De Alta Compleijdad Cuenca Alta Nestor Kirchner
      • Buenos Aires, Argentina, B1942DOL
        • Hospital del Bicentenario de Esteban Echeverría
      • Buenos Aires, Argentina, C1039AAC
        • Center Sagrado Corazon
      • Buenos Aires, Argentina, C1180ABB
        • Sanatorio Guemes
      • Buenos Aires, Argentina, C1282AEL
        • Hospital De Infecciosas "Dr. Francisco Javier Muniz"
  • Brazil
      • Botucatu, Brazil, 18618-687
        • Faculdade de Medicina de Botucatu - UNESP
      • Bragança Paulista, Brazil, 12916-542
        • Hospital Universitário São Francisco na Providência de Deus
      • Campinas, Brazil
        • IPECC (Instituto De Pesquisa Clínica de Campinas)
      • Campinas, Brazil
        • Sociedade Hospital Angelina Caron
      • Curitiba, Brazil, 80010-030
        • Santa Casa de Curitiba
      • Niteroi, Brazil, 24020-096
        • Complexo Hospitalar de Niteroi
      • Porto Alegre, Brazil, 90035-003
        • Hospital de Clínicas de Porto Alegre - Infectologia - Centro de Pesquisa Clínica
      • Porto Alegre, Brazil, 90610-000
        • Hospital Sao Luca Da PUCRS
      • Rio De Janeiro, Brazil
        • Hospital Universitario Cementino Fraga Filho
      • Sao Paulo, Brazil, 04501-000
        • IDOR - D'Or Institute for Research and Education
      • Sao Paulo, Brazil, 05403-000
        • InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
      • Sorocaba, Brazil, 18040-425
        • Hospital Miguel Soeiro Sorocaba
      • São Paulo, Brazil
        • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Fundação Pio XII - Hospital de Amor de Barretos
      • Campinas, Sao Paulo, Brazil, 13060-904
        • Hospital PUC Campinas
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • MHAT Blagoevgrad AD Department of Infectious Diseases
      • Haskovo, Bulgaria, 6304
        • Multiprofile Hospital for Active Treatment - Haskovo, Department of Infectious Diseases
      • Kardzhali, Bulgaria, 6600
        • Multiprofile Hospital for Active Treatment - Dr. Atanas Dafovski AD, Kardzhali, Department of Pneumology and Phthisiatry, Dept. of Pneumology & Phthisiatry
      • Pernik, Bulgaria, 2300
        • Specialized hospital for active treatment of pulmonary diseases -Pernik EOOD, Pernik
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hospital for Active Treatment "Pulmed" OOD Plovid Rheumatology
      • Smolyan,, Bulgaria, 4700
        • MHAT Bratan Shukerov,Pulmonology Department
      • Sofia, Bulgaria, 1527
        • University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD, Sofia,
      • Sofia, Bulgaria, 1606
        • Multiprofile Hospital for Active Treatment and Emergency Medicine
      • Stara Zagora, Bulgaria, 6003
        • University Multiprofile Hospital for Active Treatment "Professor Doctor Stoyan Kirkovich" AD, Stara Zagora, Clinic of Anaestheology and intensive care
  • Colombia
      • Atlántico, Colombia, 080001
        • Fundación Hospital Universidad del Norte (Barranquilla)
      • Barranquilla, Colombia, 080020
        • Clinica de la Costa (Barranquilla)
      • Bogotá, Colombia, 111311
        • Fundación Cardioinfantil-Instituto de Cardiología
      • Cali, Colombia, 760042
        • Centro Medico Imbanaco de Cali S.A
      • Rionegro, Colombia, 050023
        • Sociedad Medica Rionegro- Clínica Somer (Rionegro)
  • Mexico
      • Culiacán, Mexico, 80230
        • Hospital General de Culiacan
      • Zapopan, Mexico
        • Hospital General de Occidente
    • Nuevo Leon
      • San Nicolas de los Garza, Nuevo Leon, Mexico, 66465
        • Unidad Medica para la Salud Integral (UMSI)
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Honor Health
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • St. Bernard's Medical Center
    • California
      • Chula Vista, California, United States, 91911
        • Velocity Clinical Research
      • La Mesa, California, United States, 91942
        • Velocity Clinical Research - San Diego
    • Florida
      • Miami, Florida, United States, 33155
        • Westchester General Hospital, Research Department
      • Tampa, Florida, United States, 33612
        • James A. Haley Veterans Hospital
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Wellstar Research Institute
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Benchmark Research
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Methodist Hospital
      • Saint Paul, Minnesota, United States, 55426
        • Regions Hospital
    • New Jersey
      • Mullica Hill, New Jersey, United States, 08062
        • Inspira Medical Center Mullica Hill
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center, Institute for Clinical Research
      • Vineland, New Jersey, United States, 08360
        • Inspira Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health Carolinas Medical Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Stern Cardiovascular Foundation, Inc.
      • Memphis, Tennessee, United States, 38103
        • Regional One Health
      • Powell, Tennessee, United States, 37849
        • North Knoxville Medical Center
    • Texas
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Houston, Texas, United States, 77024
        • HD Research (Memorial Hermann - Memorial City Medical Center)
      • Houston, Texas, United States, 77024
        • HD Research (Memorial Hermann Southeast Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Provide informed consent from the subject or the subject's Legally Authorized Representative (LAR)
  • Aged ≥18 years
  • Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test
  • Patients with a WHO Ordinal Scale for Clinical Improvement score of 4 at high risk for ARDS, must have at least one of the known comorbidities for being at high risk, such as, Asthma (moderate to severe), Chronic Lung Disease, Diabetes, Hypertension, Severe Obesity (BMI ≥40), 65 years of age or older, primarily reside in a nursing home or long-term care facility, or immunocompromised and patients with a WHO Ordinal Scale for Clinical Improvement score of 5 or 6 regardless of presence of comorbidities.
  • WHO Ordinal Scale for Clinical Improvement score of 4 (Oxygen by mask or nasal prongs), 5 (Non-invasive ventilation or high-flow oxygen) or 6 (Intubation and mechanical ventilation)
  • Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air at screening. If patient is on oxygen therapy at the time of presentation for screening and the SpO2 levels were ≤94% prior to introduction to oxygen therapy with proper documentation example EMT notes or ER/ED notes, then the patient is considered to have met this inclusion criterion. If patient is on oxygen therapy at the time of presentation for screening and the SpO2 levels prior to introduction to oxygen therapy are unknown, the patient may be considered to have met this inclusion criterion if oxygen therapy is removed and the SpO2 levels fall to ≤94%, then the patient is considered to have met this inclusion criterion. However, removal of the oxygen therapy should only be done if it is considered medically reasonable
  • Subjects must agree to follow doctor's recommendation for oxygen supplementation

  • Subjects must agree to use acceptable methods of contraception:

    • If female of childbearing potential or a male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6months 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 the female partner of a male subject has undergone documented tuballigation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)should also be used
    • If 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

Exclusion Criteria:

  • Known hypersensitivity or allergy to colchicine
  • Pregnant or currently breast feeding
  • Participation in any other clinical trial of an experimental treatment for COVID- 19. Convalescent plasma, dexamethasone and remdesivir are allowed in this study.
  • Concurrent treatment with other experimental agents with actual or possible direct acting antiviral activity against COVID-19is prohibited <24 hours prior to study drug dosing(except standard of care). Remdesivir, dexamethasone and convalescent plasma are allowed in the study.
  • Requiring ventilation + additional organ support - pressors, RRT, ECMO(WHO Ordinal Scale for Clinical Improvement - Score of 7). NOTE: short term (PRN) use of pressors is allowed
  • Alanine Aminotransferase (ALT) or aspartate aminotransferase(AST) >3X 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
  • History of hepatitis - (Hepatitis B and C) NOTE: treated and controlled hepatitis C is allowed
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 9mg of VERU-111 Oral daily
9mg of VERU-111
Drug: 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.
Other Names:
  • Sabizabulin
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of Sabizabulin in the Treatment of SARS-CoV-2 Infection by Assessing Its Effect on the Proportion of Patients Who Died on Study.
Time Frame: Day 60
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).
Day 60

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Proportion of Subjects That Are Alive Without Respiratory Failure at Day 15, Day 22 and Day 29.
Time Frame: Day 15, Day 22, 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.
Day 15, Day 22, Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Veru Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V3011902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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