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

NCT ID: NCT04842747

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-18
• Study Completion Date: 2022-07-06

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).

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).

Conditions

SARS-CoV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

9mg of VERU-111 Oral daily

9mg of VERU-111

Group Type: EXPERIMENTAL

VERU-111

Intervention Type: DRUG

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Sabizabulin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Veru Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barnette

Role: STUDY_CHAIR

Veru Inc.

Locations

Honor Health

Scottsdale, Arizona, United States

St. Bernard's Medical Center

Jonesboro, Arkansas, United States

Velocity Clinical Research

Chula Vista, California, United States

Velocity Clinical Research - San Diego

La Mesa, California, United States

Westchester General Hospital, Research Department

Miami, Florida, United States

James A. Haley Veterans Hospital

Tampa, Florida, United States

Wellstar Research Institute

Marietta, Georgia, United States

Benchmark Research

Covington, Louisiana, United States

Methodist Hospital

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Inspira Medical Center Mullica Hill

Mullica Hill, New Jersey, United States

Holy Name Medical Center, Institute for Clinical Research

Teaneck, New Jersey, United States

Inspira Medical Center

Vineland, New Jersey, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, United States

The Stern Cardiovascular Foundation, Inc.

Germantown, Tennessee, United States

Regional One Health

Memphis, Tennessee, United States

North Knoxville Medical Center

Powell, Tennessee, United States

HD Research (Memorial Hermann - Memorial City Medical Center)

Houston, Texas, United States

HD Research (Memorial Hermann Southeast Hospital)

Houston, Texas, United States

Clinical Trial Network

Houston, Texas, United States

Hospital De Alta Compleijdad Cuenca Alta Nestor Kirchner

Buenos Aires, , Argentina

Hospital del Bicentenario de Esteban Echeverría

Buenos Aires, , Argentina

Center Sagrado Corazon

Buenos Aires, , Argentina

Sanatorio Güemes

Buenos Aires, , Argentina

Hospital De Infecciosas "Dr. Francisco Javier Muniz"

Buenos Aires, , Argentina

Fundacao Pio XII - Hospital de Amor de Barretos

Barretos, São Paulo, Brazil

Hospital PUC Campinas

Campinas, São Paulo, Brazil

Faculdade de Medicina de Botucatu - UNESP

Botucatu, , Brazil

Hospital Universitário São Francisco na Providencia de Deus

Bragança Paulista, , Brazil

IPECC (Instituto De Pesquisa Clínica de Campinas)

Campinas, , Brazil

Sociedade Hospital Angelina Caron

Campinas, , Brazil

Santa Casa de Curitiba

Curitiba, , Brazil

Complexo Hospitalar de Niteroi

Niterói, , Brazil

Hospital de Clínicas de Porto Alegre - Infectologia - Centro de Pesquisa Clínica

Porto Alegre, , Brazil

Hospital Sao Luca Da PUCRS

Porto Alegre, , Brazil

Hospital Universitario Cementino Fraga Filho

Rio de Janeiro, , Brazil

IDOR - D'Or Institute for Research and Education

São Paulo, , Brazil

Incor - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, , Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São Paulo, , Brazil

Hospital Miguel Soeiro Sorocaba

Sorocaba, , Brazil

MHAT Blagoevgrad AD Department of Infectious Diseases

Blagoevgrad, , Bulgaria

Multiprofile Hospital for Active Treatment - Haskovo, Department of Infectious Diseases

Haskovo, , Bulgaria

Multiprofile Hospital for Active Treatment - Dr. Atanas Dafovski AD, Kardzhali, Department of Pneumology and Phthisiatry, Dept. of Pneumology & Phthisiatry

Kardzhali, , Bulgaria

Specialized hospital for active treatment of pulmonary diseases -Pernik EOOD, Pernik

Pernik, , Bulgaria

University Multiprofile Hospital for Active Treatment "Pulmed" OOD Plovid Rheumatology

Plovdiv, , Bulgaria

MHAT Bratan Shukerov,Pulmonology Department

Smolyan, , Bulgaria

University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD, Sofia,

Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment and Emergency Medicine

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment "Professor Doctor Stoyan Kirkovich" AD, Stara Zagora, Clinic of Anaestheology and intensive care

Stara Zagora, , Bulgaria

Fundación Hospital Universidad del Norte (Barranquilla)

Atlántico, , Colombia

Clinica de la Costa (Barranquilla)

Barranquilla, , Colombia

Fundación Cardioinfantil-Instituto de Cardiología

Bogotá, , Colombia

Centro Medico Imbanaco de Cali S.A

Cali, , Colombia

Sociedad Medica Rionegro- Clínica Somer (Rionegro)

Rionegro, , Colombia

Unidad Médica para la Salud Integral (UMSI)

San Nicolás de los Garza, Nuevo León, Mexico

Hospital General de Culiacán

Culiacán, , Mexico

Hospital General de Occidente

Zapopan, , Mexico

Countries

United States; Argentina; Brazil; Bulgaria; Colombia; Mexico

References

Barnette KG, Gordon MS, Rodriguez D, Bird TG, Skolnick A, Schnaus M, Skarda PK, Lobo S, Sprinz E, Arabadzhiev G, Kalaydzhiev P, Steiner M. Oral Sabizabulin for High-Risk, Hospitalized Adults with Covid-19: Interim Analysis. NEJM Evid. 2022 Sep;1(9):EVIDoa2200145. doi: 10.1056/EVIDoa2200145. Epub 2022 Jul 6.

Reference Type: DERIVED

PMID: 38319812 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

V3011902

Identifier Type: -

Identifier Source: org_study_id