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

NCT04842747 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: V3011902
• Study Type: interventional
• Target: 204
• Locations: 6 countries
• Sites: 58

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).

Conditions

SARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

• Efficacy of Sabizabulin in the Treatment of SARS-CoV-2 Infection by Assessing Its Effect on the Proportion of Patients Who Died on Study.

  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 Outcomes (1)

• The Proportion of Subjects That Are Alive Without Respiratory Failure at Day 15, Day 22 and Day 29.

  Day 15, Day 22, Day 29

Study Arms (2)

9mg of VERU-111 Oral daily

EXPERIMENTAL

9mg of VERU-111

Drug: VERU-111

Placebo Capsule once daily

NO INTERVENTION

Subjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital.

Interventions

VERU-111 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.

Also known as: Sabizabulin

9mg of VERU-111 Oral daily

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Veru Inc.: lead

Study Sites (58)

Honor Health

Scottsdale, Arizona, 85258, United States

Location

St. Bernard's Medical Center

Jonesboro, Arkansas, 72401, United States

Location

Velocity Clinical Research

Chula Vista, California, 91911, United States

Location

Velocity Clinical Research - San Diego

La Mesa, California, 91942, United States

Location

Westchester General Hospital, Research Department

Miami, Florida, 33155, United States

Location

James A. Haley Veterans Hospital

Tampa, Florida, 33612, United States

Location

Wellstar Research Institute

Marietta, Georgia, 30060, United States

Location

Benchmark Research

Covington, Louisiana, 70433, United States

Location

Methodist Hospital

Saint Louis Park, Minnesota, 55426, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55426, United States

Location

Inspira Medical Center Mullica Hill

Mullica Hill, New Jersey, 08062, United States

Location

Holy Name Medical Center, Institute for Clinical Research

Teaneck, New Jersey, 07666, United States

Location

Inspira Medical Center

Vineland, New Jersey, 08360, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

The Stern Cardiovascular Foundation, Inc.

Germantown, Tennessee, 38138, United States

Location

Regional One Health

Memphis, Tennessee, 38103, United States

Location

North Knoxville Medical Center

Powell, Tennessee, 37849, United States

Location

HD Research (Memorial Hermann - Memorial City Medical Center)

Houston, Texas, 77024, United States

Location

HD Research (Memorial Hermann Southeast Hospital)

Houston, Texas, 77024, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Hospital De Alta Compleijdad Cuenca Alta Nestor Kirchner

Buenos Aires, 1814, Argentina

Location

Hospital del Bicentenario de Esteban Echeverría

Buenos Aires, B1942DOL, Argentina

Location

Center Sagrado Corazon

Buenos Aires, C1039AAC, Argentina

Location

Sanatorio Güemes

Buenos Aires, C1180ABB, Argentina

Location

Hospital De Infecciosas "Dr. Francisco Javier Muniz"

Buenos Aires, C1282AEL, Argentina

Location

Fundacao Pio XII - Hospital de Amor de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Hospital PUC Campinas

Campinas, São Paulo, 13060-904, Brazil

Location

Faculdade de Medicina de Botucatu - UNESP

Botucatu, 18618-687, Brazil

Location

Hospital Universitário São Francisco na Providencia de Deus

Bragança Paulista, 12916-542, Brazil

Location

IPECC (Instituto De Pesquisa Clínica de Campinas)

Campinas, Brazil

Location

Sociedade Hospital Angelina Caron

Campinas, Brazil

Location

Santa Casa de Curitiba

Curitiba, 80010-030, Brazil

Location

Complexo Hospitalar de Niteroi

Niterói, 24020-096, Brazil

Location

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

Porto Alegre, 90035-003, Brazil

Location

Hospital Sao Luca Da PUCRS

Porto Alegre, 90610-000, Brazil

Location

Hospital Universitario Cementino Fraga Filho

Rio de Janeiro, Brazil

Location

IDOR - D'Or Institute for Research and Education

São Paulo, 04501-000, Brazil

Location

Incor - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, 05403-000, Brazil

Location

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São Paulo, Brazil

Location

Hospital Miguel Soeiro Sorocaba

Sorocaba, 18040-425, Brazil

Location

MHAT Blagoevgrad AD Department of Infectious Diseases

Blagoevgrad, 2700, Bulgaria

Location

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

Haskovo, 6304, Bulgaria

Location

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

Kardzhali, 6600, Bulgaria

Location

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

Pernik, 2300, Bulgaria

Location

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

Plovdiv, 4002, Bulgaria

Location

MHAT Bratan Shukerov,Pulmonology Department

Smolyan, 4700, Bulgaria

Location

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

Sofia, 1527, Bulgaria

Location

Multiprofile Hospital for Active Treatment and Emergency Medicine

Sofia, 1606, Bulgaria

Location

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

Stara Zagora, 6003, Bulgaria

Location

Fundación Hospital Universidad del Norte (Barranquilla)

Atlántico, 080001, Colombia

Location

Clinica de la Costa (Barranquilla)

Barranquilla, 080020, Colombia

Location

Fundación Cardioinfantil-Instituto de Cardiología

Bogotá, 111311, Colombia

Location

Centro Medico Imbanaco de Cali S.A

Cali, 760042, Colombia

Location

Sociedad Medica Rionegro- Clínica Somer (Rionegro)

Rionegro, 050023, Colombia

Location

Unidad Médica para la Salud Integral (UMSI)

San Nicolás de los Garza, Nuevo León, 66465, Mexico

Location

Hospital General de Culiacán

Culiacán, 80230, Mexico

Location

Hospital General de Occidente

Zapopan, Mexico

Location

Related Publications (1)

• 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.

  PMID: 38319812 DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

sabizabulin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Gary Barnette PhD CSO
• Organization: Veru

veruclinicaltrials@verupharma.com

800-606-9382

Study Officials

• Barnette

  Veru Inc.

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 13, 2021
• Study Start: May 18, 2021
• Primary Completion: July 6, 2022
• Study Completion: July 6, 2022
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (15); BU (9); AR (5); US (21); CO (5); ME (3)