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Trial record 1 of 2 for:    Veru111
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COVID-19 Treatment of Severe Acute Respiratory Syndrome With Veru-111

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04388826
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Veru Inc.

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 subjects that are alive without respiratory failure at Day 22. Respiratory failure is defined as non-invasive ventilation or high-flow oxygen, intubation and mechanical ventilation, or ventilation with additional organ support (e.g., pressors, RRT, ECMO).

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Drug: Veru-111 Phase 2

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 18 mg of VERU-111 or matching placebo orally or through nasogastric tube daily for 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 are alive without respiratory failure at Day 22. Respiratory failure is defined as non-invasive ventilation or high-flow oxygen, intubation and mechanical ventilation, or ventilation with additional organ support (e.g., pressors, RRT, ECMO).

The total study duration for a subject from screening to follow up visit is planned to be 62 days.

An evaluation of the effect of VERU-111 on SARS-CoV-2 (COVID-19) compared to the placebo control will be evaluated after the last subject has completed Day 22. This will allow for the decision to move to Phase 3 more quickly if the Phase 2 portion of the study shows a clinically relevant difference in the proportion of subjects that are alive without respiratory failure at Day 22 in the VERU-111 treated groups compared to the Placebo treatment group and VERU-111 is well tolerated in the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind Randomized Placebo-Controlled
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled, Phase 2 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 : June 18, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 18, 2020


Arm Intervention/treatment
Experimental: Veru-111 18 mg
Veru-111 18mg capsules
Drug: Veru-111
Respiratory Distress Syndrome, Adult
Other Name: Bisindole

Placebo Comparator: Placebo
Placebo capsules
Drug: Veru-111
Respiratory Distress Syndrome, Adult
Other Name: Bisindole




Primary Outcome Measures :
  1. Proportion of subjects that are alive without respiratory failure at Day 29. [ Time Frame: Day 29 ]
    To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at 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


Secondary Outcome Measures :
  1. WHO clinical Improvement [ Time Frame: Day15 Day 22 and Day 29 ]
    Improvement on the WHO Ordinal Scale for Clinical Improvement (8-point ordinal scale)

  2. Normalization of Fever and Oxygen [ Time Frame: Day 15, Day 22, and Day 29 ]
    Proportion of subjects with normalization of fever and oxygen saturation through

  3. Discharge from Hospital [ Time Frame: Day 15 and Day 22 ]
    Percentage of subjects discharged from hospital

  4. Patients alive and free of respiratory failure [ Time Frame: Day 15, and Day 22 ]
    Proportion of patients alive and free of respiratory failure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide informed consent
  2. Be able to communicate effectively with the study personnel
  3. Aged ≥18 years
  4. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test
  5. Patients at high risk for ARDS, with known comorbidities for being at high risk, such as, Asthma (moderate to severe), Chronic Lung Disease, Diabetes, Chronic Kidney Disease being treated with dialysis, Severe Obesity (BMI ≥40), 65 years of age or older, primarily reside in a nursing home or long-term care facility, immunocompromised
  6. Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air at screening
  7. Subjects must agree to use acceptable methods of contraception

    • If subject is female or the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months 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 female subject or the female partner of a male subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used
    • If female subject or the 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
  8. Subject is willing to comply with the requirements of the protocol through the end of the study

Exclusion Criteria:

  1. Known hypersensitivity or allergy to colchicine
  2. Participation in any other clinical trial of an experimental treatment for COVID-19
  3. Concurrent treatment with other experimental agents with actual or possible direct acting antiviral activity against COVID-19 is prohibited < 24 hours prior to study drug dosing (except standard of care) Remdesivir and convalescent plasma is allowed as standard of care.
  4. Requiring mechanical ventilation at screening
  5. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) >2 X upper limit of normal (ULN)
  6. Total bilirubin > ULN
  7. Creatinine clearance < 60 mL/min
  8. 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
  9. Moderate to severe renal impairment
  10. Hepatic impairment
  11. Positive for HbsAg, or HCV antibodies at screening
  12. 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
  13. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388826


Contacts
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Contact: Gary Barnette (919) 426-3611 gbarnette@verupharma.com
Contact: Domingo Rodriguez (901) 485-3370 drodriguez@verupharma.com

Locations
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United States, Arizona
HonorHealth Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Karen Lewandowski    480-583-0760    klewandowski@honorhealth.com   
United States, Minnesota
Methodist Hospital Recruiting
Saint Louis Park, Minnesota, United States, 55426
Contact: Jenny Koops         
Contact: Jenny.J.Koops@HealthPartners.Com         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Jenny Koops       Jenny.J.Koops@HealthPartners.Com   
United States, Nevada
WC-CRCN at North Vista Hospital Not yet recruiting
Las Vegas, Nevada, United States, 89117
Contact: Adolfo DeLeon       adeleon@crcnnv.com   
United States, New Jersey
Inspira Medical Center Recruiting
Vineland, New Jersey, United States, 08360
Contact: Jennifer Stanford       j_stanfor@yahoo.com   
United States, Texas
Memorial Hermann Memorial City Hospital Recruiting
Houston, Texas, United States, 77024
Contact: Katelyn Freeman       kfreeman@lotuscr.com   
Sponsors and Collaborators
Veru Inc.
Investigators
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Study Director: Gary Barnette Veru Inc.
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Responsible Party: Veru Inc.
ClinicalTrials.gov Identifier: NCT04388826    
Other Study ID Numbers: V0211901
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Lung Injury