HC-1119 Adjuvant Treatment for Hospitalized COVID-19 Patients


Applied Biology

Status and phase

Phase 3


COVID-19 Respiratory Infection


Drug: Placebo
Drug: HC-1119

Study type


Funder types




Details and patient eligibility


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.

Full description

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.


602 estimated patients




18 to 85 years old


No Healthy Volunteers

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:

      1. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID - 19 related or otherwise);
      1. Hospitalized, requiring supplemental oxygen;
      1. 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

Trial design

Primary purpose




Interventional model

Parallel Assignment


Triple Blind

602 participants in 2 patient groups, including a placebo group

HC-1119 + Usual Care
Experimental group
4 (40mg) soft gel capsule, 160 mg total
Drug: HC-1119
Placebo + Usual Care
Placebo Comparator group
4 soft gel capsule
Drug: Placebo

Trial contacts and locations



Data sourced from

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