The primary purpose of this study is to evaluate the efficacy of HC-1119 as an adjuvant treatment for hospitalized COVID-19 male and female patients.
This study is designed as a prospective, superiority, interventionist, placebo-controlled,
double-blinded, randomized parallel assignment study. The study evaluates the efficacy and
safety of HC- 1119.
Participants will be screened for eligibility; the assessment should be completed prior to
any randomization to avoid screening failures to a maximum extent. Eligible participants (men
and women) will be randomized 1:1 between arms (HC-1119 and placebo). HC-1119 and placebo
will be administered orally.
The dosing regimen is 160 mg daily for 14 consecutive days. All patients will receive in
parallel the standard treatment for COVID -19, according to the institution's protocol.
An electronic program will be used to manage randomization and drug shipment. The whole
process will be handled in a manner that is blinded for the treatment received to all
involved study personnel. The study follow up period will be 28 days after the first
treatment.
Drug: HC-1119
oral
Drug: Placebo
oral
Inclusion Criteria:
1. Admitted to the hospital with symptoms of COVID-19.
2. Male and females age ≥18 years old.
3. Confirmed positive SARS-CoV-2, through existing RT-PCR test within 7 days prior to
randomization.
4. Patients with clinical status categorized of scores 4, 5, or 6 on the COVID-19 Ordinal
Scale:
- 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical
care (COVID - 19 related or otherwise);
- 5) Hospitalized, requiring supplemental oxygen;
- 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices;
5. Participant able to swallow 4 capsules sequentially of the medication under
investigation/ placebo
6. Coagulation: INR ≤ 1.5 ×ULN, and APTT ≤ 1.5×ULN
7. Women of child-bearing potential must have negative results of plasma pregnancy test
(serum HCG).
8. Participant (or legally authorized representative) gives written informed consent
prior to performing any study procedures.
9. Participant (or legally authorized representative) agree that participant will not
participate in another COVID-19 trial while participating in this study.
Exclusion Criteria:
1. Participant enrolled in another interventionist study for COVID -19 treatment.
2. Patients requiring mechanical ventilation.
3. Patients taking an anti-androgen of any type including: androgen depravation therapy,
5-alpha reductase inhibitors, etc, having last dose of treatment less than 3 months
prior to screening.
4. Patients who are allergic to the investigational product or similar drugs (or any
excipients).
5. Patients has malignant tumors in the past 5 years, except for completed resected basal
cell and squamous cell skin cancer and completely resected carcinoma in situ of any
type.
6. Patient with known serious cardiovascular disease:
1. Heart Failure NYHA III.
2. Heart Failure NYHA IV.
3. Angina class III -Canadian cardiovascular Society.
4. Angina class IV -Canadian cardiovascular Society
5. Angina with recent onset of symptoms, whose symptoms started 30 days or less.
6. Myocardial infarction the last 3 months.
7. Stroke in the last 3 months.
7. Patient with a history of seizures/epilepsy.
8. Patient taking any medications (or combination of medications) that could induce
seizures/epilepsy during the study period.
9. Patient with uncontrolled medical conditions despite adequate medication, that could
compromise participation in the study (e.g., uncontrolled hypertension,
hypothyroidism, diabetes mellitus).
10. Known diagnosis of human immunodeficiency virus (HIV), hepatitis C, active hepatitis
B, treponema pallidum (testing is not mandatory).
11. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit
of normal.
12. Estimated glomerular filtration rate (eGFR) < 30 ml/min.
13. Severe kidney disease requiring dialysis.
14. Patient likely to transfer to another hospital within 28 days after hospitalization.
15. Women of childbearing potential, defined as all women physiologically capable of
becoming pregnant, unless using a highly effective method of contraception (detailed
in the study protocol) throughout the study and for 3 months after stopping treatment
with HC-1119.
16. Sexually active men who refuse to use a condom during intercourse while taking HC-1119
and for 3 months after stopping treatment.
17. Pregnant, breastfeeding, or women planning to become pregnant 3 months after treatment
with HC-1119
18. Participant (or legally authorized representative) not willing or unable to provide
informed consent