COVID-19 Treatment of Severe Acute Respiratory Syndrome With Veru-111
Condition: Respiratory Distress Syndrome, Adult
MeSH terms: Severe Acute Respiratory Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: Veru-111
Intervention description: Respiratory Distress Syndrome, Adult
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

Eligibility 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.