Proxalutamide Treatment for Hospitalized COVID-19 Patients
Condition: Covid19; SARS (Severe Acute Respiratory Syndrome)
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Intervention: Proxalutamide; Placebo
Intervention description: Proxalutamide 300mg q.d; Placebo pill
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is designed as a prospective, interventional, placebo controlled, double-blinded, randomized parallel assignment study.
Masking: Double (Participant, Care Provider)
Masking description: Double (Participant, Care Provider)
Enrollment: 645.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Proxalutamide; Androgen; Anti-androgen

Summary:

      The purpose of this study is to assess the efficacy and safety of Proxalutamide as a
      treatment for hospitalized COVID-19 male and female patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Admitted to the hospital with symptoms of COVID-19

          2. Male and females age ≥18 years old

          3. Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to
             randomization

          4. Clinical status on the COVID-19 Ordinal Scale (defined in Section 5.1) of 3, 4, 5, or
             6

          5. Coagulation: INR ≤ 1.5×ULN, and APTT ≤ 1.5×ULN

          6. Subject (or legally authorized representative) gives written informed consent prior to
             performing any study procedures

          7. Subject (or legally authorized representative) agree that subject will not participate
             in another COVID-19 trial while participating in this study

        Exclusion Criteria:

          1. Subject enrolled in a study to investigate a treatment for COVID-19

          2. Requires mechanical ventilation

          3. Subject taking an anti-androgen of any type including: androgen depravation therapy,
             5-alpha reductase inhibitors, etc…

          4. Patients who are allergic to the investigational product or similar drugs (or any
             excipients);

          5. Subjects who have malignant tumors in the past 5 years, with the exception of
             completed resected basal cell and squamous cell skin cancer and completely resected
             carcinoma in situ of any type

          6. Subjects with known serious cardiovascular diseases, congenital long QT syndrome,
             torsade de pointes, myocardial infarction in the past 6 months, or arterial
             thrombosis, or unstable angina pectoris, or congestive heart failure which is
             classified as New York Heart Association (NYHA) class 3 or higher, or left ventricular
             ejection fraction (LVEF) < 50%, QTcF > 450 ms

          7. Subjects with uncontrolled medical conditions that could compromise participation in
             the study(e.g. uncontrolled hypertension, hypothyroidism, diabetes mellitus)

          8. Known diagnosis of human immunodeficiency virus(HIV) , hepatitis C, active hepatitis
             B, treponema pallidum (testing is not mandatory）

          9. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit
             of normal.

         10. Estimated glomerular filtration rate (eGFR) < 30 ml/min

         11. Severe kidney disease requiring dialysis

         12. Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they are using highly effective contraception, as shown
             below, throughout the study and for 3 months after stopping GT0918 treatment. Highly
             effective contraception methods include:

               -  Total Abstinence (when this is in line with the preferred and usual lifestyle of
                  the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal,
                  post-ovulation methods) and withdrawal are not acceptable methods of
                  contraception, or

               -  Use of one of the following combinations (a+b or a+c or b+c):

                    1. Use of oral, injected or implanted hormonal methods of contraception or
                       other forms of hormonal contraception that have comparable efficacy (failure
                       rate < 1%), for example hormone vaginal ring or transdermal hormone
                       contraception.

                    2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) ;

                    3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
                       cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal
                       suppository ;

               -  Female sterilization (have had prior surgical bilateral oophorectomy with or
                  without hysterectomy) or tubal ligation at least six weeks before taking study
                  treatment. In case of oophorectomy alone, only when the reproductive status of
                  the woman has been confirmed by follow-up hormone level assessment ;

               -  Male sterilization (at least 6 months prior to screening). For female patients on
                  the study, the vasectomized male partner should be the sole partner for that
                  patient;

               -  In case of use of oral contraception women should have been stable for a minimum
                  of 3 months before taking study treatment. Women are considered post-menopausal
                  and not of child bearing potential if they have had 12 months of natural
                  (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age
                  appropriate, history of vasomotor symptoms) or have had surgical bilateral
                  oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks
                  ago. In the case of oophorectomy alone, only when the reproductive status of the
                  woman has been confirmed by follow up hormone level assessment, is she considered
                  not of child bearing potential;

         13. Sexually active males must use a condom during intercourse while taking the drug and
             for 3 months after stopping GT0918 treatment and should not father a child in this
             period. A condom is required to be used also by vasectomized men in order to prevent
             delivery of the drug via seminal fluid

         14. Subject likely to transfer to another hospital within the next 28 days

         15. Subject (or legally authorized representative) not willing or unable to provide
             informed consent