NCT04986176Unknown3 期
HC-1119 Adjuvant Treatment for Hospitalized COVID-19 Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 602
- 主要终点
- All-cause mortality risk ratio assessed by the proportion of patient deaths in both study arms.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the hospital with symptoms of COVID-
- •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.
排除标准
- •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.
- •Patient with uncontrolled medical conditions despite adequate medication, that could compromise participation in the study (e.g., uncontrolled hypertension, hypothyroidism, diabetes mellitus).
- •Known diagnosis of human immunodeficiency virus (HIV), hepatitis C, active hepatitis B, treponema pallidum (testing is not mandatory).
- •Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal.
- •Estimated glomerular filtration rate (eGFR) < 30 ml/min.
- •Severe kidney disease requiring dialysis.
- •Patient likely to transfer to another hospital within 28 days after hospitalization.
- •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-
- •Sexually active men who refuse to use a condom during intercourse while taking HC-1119 and for 3 months after stopping treatment.
- •Pregnant, breastfeeding, or women planning to become pregnant 3 months after treatment with HC-1119
- •Participant (or legally authorized representative) not willing or unable to provide informed consent
研究组 & 干预措施
HC-1119 + Usual Care
Experimental
4 (40mg) soft gel capsule, 160 mg total
干预措施: HC-1119 (Drug)
Placebo + Usual Care
Placebo Comparator
4 soft gel capsule
干预措施: Placebo (Drug)
结局指标
主要结局
All-cause mortality risk ratio assessed by the proportion of patient deaths in both study arms.
时间窗: 28 days
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.
次要结局
- 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)
- Recovery ratio assessed by measuring the proportion of recovered patients in both study arms.(14 days)
- Pharmacokinetics of HC-1119 assessed by peak time (Tmax)(14 days)
- Post-randomization time to recover/alive hospital discharge assessed by the median days (interquartile range) of time to recover.(28 days)
- Pharmacokinetics of HC-1119 assessed by area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration (AUC 0-t)(14 days)
- Pharmacokinetics of HC-1119 assessed by peak concentration (Cmax)(14 days)
- Pharmacokinetics of HC-1119 assessed by elimination half-life (t 1/2)(14 days)
- Efficacy of concomitant therapies assessed by sensitivity analysis of the primary, and key secondary outcomes.(28 days)
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