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

Sponsor
Veru Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04842747
Collaborator
(none)
210
Enrollment
58
Locations
2
Arms
16.1
Anticipated Duration (Months)
3.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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 patients who die on study (prior to Day 60).

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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. Subjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital.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. Subjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
The study will be a randomized, double-blind, placebo-controlled study. Randomization will be stratified by baseline WHO Ordinal Scale score of 4,5 and 6 such that subjects with a WHO Ordinal Scale of 4, 5 and 6 at screening are approximately equally distributed between the treatment groups. An emergency code break will be available to the investigator / pharmacist / investigational drug storage manager. This code break option in IWRS may only be disclosed in emergency situations when the identity of the trial drug must be known to the investigator in order to provide appropriate medical treatment or if required to assure safety of trial participants. If the code break for a patient is opened, the sponsor and CRO will be informed immediately via IWRS notification. The reason for the IWRS unblinding of the subject must be documented on the appropriate eCRF page along with the date and the initials of the person who broke the code.
Primary Purpose:
Treatment
Official Title:
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).
Actual Study Start Date :
May 18, 2021
Actual Primary Completion Date :
Jul 6, 2022
Anticipated Study Completion Date :
Sep 21, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

    Outcome Measures

    Primary Outcome Measures

    1. VERU-111 in the treatment of SARS-Cov-2 Infection [Day 60]

      VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of patients who die on study.

    Secondary Outcome Measures

    1. To determine the percentage of subjects that are alive without respiratory failure at various intervals. [Day 29]

      The proportion of subjects that are alive without respiratory failure at Day 15, Day 22 and Day 29. Day 29 is the key secondary end point in this study. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Veru Inc.

    Investigators

    • Study Chair: Barnette, Veru Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Veru Inc.
    ClinicalTrials.gov Identifier:
    NCT04842747
    Other Study ID Numbers:
    • V3011902
    First Posted:
    Apr 13, 2021
    Last Update Posted:
    Jul 11, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Severe Acute Respiratory Syndrome

    Study Results

    No Results Posted as of Jul 11, 2022