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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).

NCT ID NCT04842747

NEW Sponsor: Veru Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

204 people

The number who actually took part.

Started

May 2021

Finished

Jul 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

severe acute respiratory syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SARS-CoV infection

Contacts and locations

Locations

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Benchmark Research

    Covington, Louisiana, 70433, United States

  • Center Sagrado Corazon

    Buenos Aires, C1039AAC, Argentina

  • Centro Medico Imbanaco de Cali S.A

    Cali, 760042, Colombia

  • Clinica de la Costa (Barranquilla)

    Barranquilla, 080020, Colombia

  • Clinical Trial Network

    Houston, Texas, 77074, United States

  • Complexo Hospitalar de Niteroi

    Niterói, 24020-096, Brazil

  • Faculdade de Medicina de Botucatu - UNESP

    Botucatu, 18618-687, Brazil

  • Fundacao Pio XII - Hospital de Amor de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Fundación Cardioinfantil-Instituto de Cardiología

    Bogotá, 111311, Colombia

  • Fundación Hospital Universidad del Norte (Barranquilla)

    Atlántico, 080001, Colombia

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São Paulo, Brazil

  • HD Research (Memorial Hermann - Memorial City Medical Center)

    Houston, Texas, 77024, United States

  • HD Research (Memorial Hermann Southeast Hospital)

    Houston, Texas, 77024, United States

  • Holy Name Medical Center, Institute for Clinical Research

    Teaneck, New Jersey, 07666, United States

  • Honor Health

    Scottsdale, Arizona, 85258, United States

  • Hospital De Alta Compleijdad Cuenca Alta Nestor Kirchner

    Buenos Aires, 1814, Argentina

  • Hospital De Infecciosas "Dr. Francisco Javier Muniz"

    Buenos Aires, C1282AEL, Argentina

  • Hospital General de Culiacán

    Culiacán, 80230, Mexico

  • Hospital General de Occidente

    Zapopan, Mexico

  • Hospital Miguel Soeiro Sorocaba

    Sorocaba, 18040-425, Brazil

  • Hospital PUC Campinas

    Campinas, São Paulo, 13060-904, Brazil

  • Hospital Sao Luca Da PUCRS

    Porto Alegre, 90610-000, Brazil

  • Hospital Universitario Cementino Fraga Filho

    Rio de Janeiro, Brazil

  • Hospital Universitário São Francisco na Providencia de Deus

    Bragança Paulista, 12916-542, Brazil

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

    Porto Alegre, 90035-003, Brazil

  • Hospital del Bicentenario de Esteban Echeverría

    Buenos Aires, B1942DOL, Argentina

  • IDOR - D'Or Institute for Research and Education

    São Paulo, 04501-000, Brazil

  • IPECC (Instituto De Pesquisa Clínica de Campinas)

    Campinas, Brazil

  • Incor - Instituto do Coração do Hospital das Clínicas da FMUSP

    São Paulo, 05403-000, Brazil

  • Inspira Medical Center

    Vineland, New Jersey, 08360, United States

  • Inspira Medical Center Mullica Hill

    Mullica Hill, New Jersey, 08062, United States

  • James A. Haley Veterans Hospital

    Tampa, Florida, 33612, United States

  • MHAT Blagoevgrad AD Department of Infectious Diseases

    Blagoevgrad, 2700, Bulgaria

  • MHAT Bratan Shukerov,Pulmonology Department

    Smolyan, 4700, Bulgaria

  • Methodist Hospital

    Saint Louis Park, Minnesota, 55426, United States

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

    Kardzhali, 6600, Bulgaria

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

    Haskovo, 6304, Bulgaria

  • Multiprofile Hospital for Active Treatment and Emergency Medicine

    Sofia, 1606, Bulgaria

  • North Knoxville Medical Center

    Powell, Tennessee, 37849, United States

  • Regional One Health

    Memphis, Tennessee, 38103, United States

  • Regions Hospital

    Saint Paul, Minnesota, 55426, United States

  • Sanatorio Güemes

    Buenos Aires, C1180ABB, Argentina

  • Santa Casa de Curitiba

    Curitiba, 80010-030, Brazil

  • Sociedad Medica Rionegro- Clínica Somer (Rionegro)

    Rionegro, 050023, Colombia

  • Sociedade Hospital Angelina Caron

    Campinas, Brazil

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

    Pernik, 2300, Bulgaria

  • St. Bernard's Medical Center

    Jonesboro, Arkansas, 72401, United States

  • The Stern Cardiovascular Foundation, Inc.

    Germantown, Tennessee, 38138, United States

  • Unidad Médica para la Salud Integral (UMSI)

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

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

    Stara Zagora, 6003, Bulgaria

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

    Plovdiv, 4002, Bulgaria

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

    Sofia, 1527, Bulgaria

  • University of North Carolina

    Chapel Hill, North Carolina, 27514, United States

  • Velocity Clinical Research

    Chula Vista, California, 91911, United States

  • Velocity Clinical Research - San Diego

    La Mesa, California, 91942, United States

  • Wellstar Research Institute

    Marietta, Georgia, 30060, United States

  • Westchester General Hospital, Research Department

    Miami, Florida, 33155, United States

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