SARS-CoV InfectionPhase 3VERU-111NCT04842747
VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study
A Phase 3 study testing VERU-111 in people with SARS-CoV Infection, run by Veru Inc. at 58 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- SARS-CoV Infection
- What is being tested?
- VERU-111
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 58 sitesin 6 countries
- Study dates
- 18 May 2021to 6 Jul 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
58 sites in 6 countries.
58 sites in 6 countries
United States21 sites
University of North Carolina
Chapel Hill, North Carolina, 27514
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
Velocity Clinical Research
Chula Vista, California, 91911
Benchmark Research
Covington, Louisiana, 70433
The Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee, 38138
HD Research (Memorial Hermann - Memorial City Medical Center)
Houston, Texas, 77024
HD Research (Memorial Hermann Southeast Hospital)
Houston, Texas, 77024
Clinical Trial Network
Houston, Texas, 77074
St. Bernard's Medical Center
Jonesboro, Arkansas, 72401
Velocity Clinical Research - San Diego
La Mesa, California, 91942
Wellstar Research Institute
Marietta, Georgia, 30060
Regional One Health
Memphis, Tennessee, 38103
Westchester General Hospital, Research Department
Miami, Florida, 33155
Inspira Medical Center Mullica Hill
Mullica Hill, New Jersey, 08062
North Knoxville Medical Center
Powell, Tennessee, 37849
Methodist Hospital
Saint Louis Park, Minnesota, 55426
Regions Hospital
Saint Paul, Minnesota, 55426
Honor Health
Scottsdale, Arizona, 85258
James A. Haley Veterans Hospital
Tampa, Florida, 33612
Holy Name Medical Center, Institute for Clinical Research
Teaneck, New Jersey, 07666
Inspira Medical Center
Vineland, New Jersey, 08360
Brazil15 sites
Fundacao Pio XII - Hospital de Amor de Barretos
Barretos, São Paulo, 14784-400
Faculdade de Medicina de Botucatu - UNESP
Botucatu, 18618-687
Hospital Universitário São Francisco na Providencia de Deus
Bragança Paulista, 12916-542
Hospital PUC Campinas
Campinas, São Paulo, 13060-904
IPECC (Instituto De Pesquisa Clínica de Campinas)
Campinas
Sociedade Hospital Angelina Caron
Campinas
Santa Casa de Curitiba
Curitiba, 80010-030
Complexo Hospitalar de Niteroi
Niterói, 24020-096
Hospital de Clínicas de Porto Alegre - Infectologia - Centro de Pesquisa Clínica
Porto Alegre, 90035-003
Hospital Sao Luca Da PUCRS
Porto Alegre, 90610-000
Hospital Universitario Cementino Fraga Filho
Rio de Janeiro
IDOR - D'Or Institute for Research and Education
São Paulo, 04501-000
Incor - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo, 05403-000
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São Paulo
Hospital Miguel Soeiro Sorocaba
Sorocaba, 18040-425
Bulgaria9 sites
MHAT Blagoevgrad AD Department of Infectious Diseases
Blagoevgrad, 2700
Multiprofile Hospital for Active Treatment - Haskovo, Department of Infectious Diseases
Haskovo, 6304
Multiprofile Hospital for Active Treatment - Dr. Atanas Dafovski AD, Kardzhali, Department of Pneumology and Phthisiatry, Dept. of Pneumology & Phthisiatry
Kardzhali, 6600
Specialized hospital for active treatment of pulmonary diseases -Pernik EOOD, Pernik
Pernik, 2300
University Multiprofile Hospital for Active Treatment "Pulmed" OOD Plovid Rheumatology
Plovdiv, 4002
MHAT Bratan Shukerov,Pulmonology Department
Smolyan, 4700
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD, Sofia,
Sofia, 1527
Multiprofile Hospital for Active Treatment and Emergency Medicine
Sofia, 1606
University Multiprofile Hospital for Active Treatment "Professor Doctor Stoyan Kirkovich" AD, Stara Zagora, Clinic of Anaestheology and intensive care
Stara Zagora, 6003
Argentina5 sites
Hospital De Alta Compleijdad Cuenca Alta Nestor Kirchner
Buenos Aires, 1814
Hospital del Bicentenario de Esteban Echeverría
Buenos Aires, B1942DOL
Center Sagrado Corazon
Buenos Aires, C1039AAC
Sanatorio Güemes
Buenos Aires, C1180ABB
Hospital De Infecciosas "Dr. Francisco Javier Muniz"
Buenos Aires, C1282AEL
Colombia5 sites
Fundación Hospital Universidad del Norte (Barranquilla)
Atlántico, 080001
Clinica de la Costa (Barranquilla)
Barranquilla, 080020
Fundación Cardioinfantil-Instituto de Cardiología
Bogotá, 111311
Centro Medico Imbanaco de Cali S.A
Cali, 760042
Sociedad Medica Rionegro- Clínica Somer (Rionegro)
Rionegro, 050023
Mexico3 sites
Hospital General de Culiacán
Culiacán, 80230
Unidad Médica para la Salud Integral (UMSI)
San Nicolás de los Garza, Nuevo León, 66465
Hospital General de Occidente
Zapopan
About this study
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).
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).
Read the 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
- Being tested
- VERU-111
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERU-111Drug
Also called Sabizabulin
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.
| Study group | Role | What they receive |
|---|---|---|
| 9mg of VERU-111 Oral daily | Experimental | 9mg of VERU-111 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 60
Secondary outcomes (1)
The Proportion of Subjects That Are Alive Without Respiratory Failure at Day 15, Day 22 and 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.
Measured: Day 15, Day 22, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start18 May 2021
- Primary completion6 Jul 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veru Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barnette, Study chair, Veru Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842747
- Sponsor's protocol ID
- V3011902
- Acronym
- VERU-111
- Status last verified
- Mar 2023
- First submitted
- 9 Apr 2021
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38319812
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04842747
- Acronym / sponsor ID
- VERU-111 / V3011902
- Conditions
- SARS-CoV Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Veru Inc.Industry (pharma, biotech, devices)
- Study start
- 18 May 2021 (actual)
- Primary completion
- 6 Jul 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 9mg of VERU-111 Oral daily | Experimental | Drug: VERU-1119mg of 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VERU-111Also: SabizabulinSubjects 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. | Drug | 9mg of VERU-111 Oral daily |
Primary outcome
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).
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38319812Barnette 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barnette study chair
Veru Inc.
58 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VERU-111 in people with SARS-CoV Infection, run by Veru Inc. at 58 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Brazil, Bulgaria, Argentina, Colombia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04842747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.