Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness
Condition: Efficacy and Safety
Intervention: Proxalutamide (GT0918); Placebo
Intervention description: Proxalutamide (GT0918)+Standard of care determined by PI and local regulatory; Placebo+Standard of care determined by PI and local regulatory
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 733.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) as a
      treatment for outpatients COVID-19 subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject or legally authorized representative give signed informed consent which
             includes compliance with the requirements and restrictions listed in the ICF and in
             this protocol.

          2. Understand and agree to comply with planned study procedures.

          3. Male subjects with age ≥18 years of age at the time of randomization.

          4. Are currently not hospitalized.

          5. Have one or more mild or moderate symptom(s) COVID-19-related symptoms within 5 days
             of onset of symptoms onset

          6. Must have first positive SARS-CoV-2 viral infection determination (has
             laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or
             public health assay in any specimen) ≤3 days prior to start of the first dose.

          7. Regardless of their fertility status, male subjects must agree to either remain
             abstinent (if this is their preferred and usual lifestyle) or use condoms as well as
             one additional highly effective method of contraception (less than 1% failure rate) or
             effective method of contraception with nonpregnant women of childbearing potential
             partners for the duration of the study and until 90 days after the last dose.

             Use an acceptable method of contraception such as:

               -  Highly effective methods of contraception (less than 1% failure rate) comprise,
                  but are not limited to

                    -  combination oral contraceptives

                    -  implanted contraceptives, or

                    -  intrauterine devices.

               -  Effective methods of contraception comprise but are not limited to

                    -  diaphragms with spermicide or cervical sponges.

                    -  men and their partners may choose to use a double-barrier method of
                       contraception that must include use of a spermicide.

          8. Agree to the collection of nasopharyngeal swabs and venous blood.

        Exclusion Criteria:

          1. Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per
             minute, heart rate ≥125 per minute

          2. Estimated glomerular filtration rate (eGFR) < 30 ml/min

          3. Serum total bilirubin > 1.5 x ULN (upper limit of normal) and AST and ALT >3x ULN

          4. Subjects with significant cardiovascular disease as following:

             i. heart failure NYHA class ≥3 ii. left ventricular ejection fraction <50% iii. those
             with a history of cardiac arrhythmias, including long QT syndrome.

          5. Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient)
             at randomization, due to COVID-19 or requires treatment with supplemental oxygen.

          6. Have known allergies to any of the components used in the formulation of the
             interventions.

          7. Have hemodynamic instability requiring use of vasopressors within 24 hours of
             randomization.

          8. Suspected or proven serious, active bacterial, fungal, viral, or other infection
             (except COVID-19) that in the opinion of the investigator could constitute a risk when
             taking intervention (i.e. known history of human immunodeficiency virus [HIV]).

          9. Have any co-morbidity requiring surgery within <7 days, or that is considered
             life-threatening within 30 days.

         10. Have any serious concomitant systemic disease, condition, or disorder that, in the
             opinion of the investigator, should preclude participation in this study.