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).
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.
Drug: Veru-111
Respiratory Distress Syndrome, Adult
Other Name: Bisindole
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.
HonorHealth
Scottsdale, Arizona, United States
Methodist Hospital
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Inspira Medical Center
Vineland, New Jersey, United States
Memorial Hermann Memorial City Hospital
Houston, Texas, United States
Barnette, Study Director
Veru Inc.