Proxalutamide Treatment for Hospitalized COVID-19 Patients

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