HC-1119 Adjuvant Treatment for Hospitalized COVID-19 Patients

NCT04986176 | Unknown Phase 3

• 1 other identifier: HC-1119-DRUG-SARS-001
• Study Type: interventional
• Target: 602
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• All-cause mortality risk ratio assessed by the proportion of patient deaths in both study arms.

  The proportion of patients reaching score 8 (death) on the COVID-19 ordinal scale at any given time up to 28 days for both study arms.

  28 days

Secondary Outcomes (10)

• Recovery ratio assessed by measuring the proportion of recovered patients in both study arms.

  28 days

• Recovery ratio assessed by measuring the proportion of recovered patients in both study arms.

  14 days

• Post-randomization time to recover/alive hospital discharge assessed by the median days (interquartile range) of time to recover.

  28 days

• Hazard ratio for death assessed by measuring the proportion of deaths by time in both study arms.

  28 days

• Pharmacokinetics of HC-1119 assessed by area under the plasma concentration-time curve from time 0 to infinity (∞) (AUC0-∞)

  14 days

Study Arms (2)

HC-1119 + Usual Care

EXPERIMENTAL

4 (40mg) soft gel capsule, 160 mg total

Drug: HC-1119

Placebo + Usual Care

PLACEBO COMPARATOR

4 soft gel capsule

Drug: Placebo

Interventions

HC-1119 DRUG

oral

HC-1119 + Usual Care

Placebo DRUG

oral

Placebo + Usual Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to the hospital with symptoms of COVID-19.
• Male and females age ≥18 years old.
• Confirmed positive SARS-CoV-2, through existing RT-PCR test within 7 days prior to randomization.
• Patients with clinical status categorized of scores 4, 5, or 6 on the COVID-19 Ordinal Scale:
• \) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID - 19 related or otherwise);
• \) Hospitalized, requiring supplemental oxygen;
• \) Hospitalized, on non-invasive ventilation or high flow oxygen devices;
• Participant able to swallow 4 capsules sequentially of the medication under investigation/ placebo
• Coagulation: INR ≤ 1.5 ×ULN, and APTT ≤ 1.5×ULN
• Women of child-bearing potential must have negative results of plasma pregnancy test (serum HCG).
• Participant (or legally authorized representative) gives written informed consent prior to performing any study procedures.
• Participant (or legally authorized representative) agree that participant will not participate in another COVID-19 trial while participating in this study.

You may not qualify if:

• Participant enrolled in another interventionist study for COVID -19 treatment.
• Patients requiring mechanical ventilation.
• 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.
• Patients who are allergic to the investigational product or similar drugs (or any excipients).
• 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.
• Patient with known serious cardiovascular disease:
• Heart Failure NYHA III.
• Heart Failure NYHA IV.
• Angina class III -Canadian cardiovascular Society.
• Angina class IV -Canadian cardiovascular Society
• Angina with recent onset of symptoms, whose symptoms started 30 days or less.
• Myocardial infarction the last 3 months.
• Stroke in the last 3 months.
• Patient with a history of seizures/epilepsy.
• Patient taking any medications (or combination of medications) that could induce seizures/epilepsy during the study period.

Sponsors & Collaborators

• Applied Biology, Inc.: lead
• Hinova Pharmaceuticals Inc.: collaborator

MeSH Terms

Interventions

enzalutamide

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, superiority, interventional, placebo-controlled, double-blinded, randomized, parallel-assignment study

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 2, 2021
• Study Start: April 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 18, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share