Study to Evaluate the Efficacy and Safety of CardiolRx™ in Patients With COVID-19 and Cardiovascular Disease or Risk Factors A Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 90
- 试验地点
- 38
- 主要终点
- Composite of All-cause Mortality, Requirement for ICU Admission and/or Ventillatory Support and Cardiovascular Complications
研究概览
简要总结
Non-critical patients, hospitalized within the previous 24 hours who tested positive for COVID-19 and have a prior history of cardiovascular disease (CVD) and/or significant risk factors for CVD will be treated for 28 days.
详细描述
Multi-center, double-blind, randomized, placebo-controlled, parallel group design. 1:1 randomization.
Screening (Day 0-1): Patients hospitalized for COVID-19 within the past 24 hours will be screened. If patient consent can be obtained, baseline assessments will be carried out: Physical examination (including vital signs), ECG including QTc interval assessment, echocardiogram to measure left-ventricular ejection fraction (LVEF), chest X-ray, local laboratory (including CBC, AST/ALT, alkaline phosphatase, bilirubin, creatinine/eGFR, INR, pregnancy test (in women with child-bearing potential only), lymphocyte count and LDH. A C-SSRS will also be completed. Frozen plasma will be retained for central analysis of CardiolRx™ levels, hs-troponin, NT-proBNP, D-dimer as well as inflammatory markers (hs-CRP, ferritin, TNF-alpha, IL-1 beta, IL-6, IL-10).
If all eligibility criteria are met, the patient will be randomized to either CardiolRx™ or placebo.
Study treatment will be initiated immediately after all baseline assessments have been completed and the patient is randomized (Day1). Oral administration is as follows:
- Day 1 and Day 2: Initial dose: 2.5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo
- Day 3 and Day 4: Increased to 5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo
- Day 5 to Day 28: Increased to 7.5 mg/kg of body weight b.i.d. with food: CardiolRx™ or placebo For the first 7 days and on Day 10, an ECG will be recorded 4 hours post morning dose with QTc intervals measured. If the QTc interval is >500 msec or an increase of > 60 msec from baseline is observed, the study medication must be stopped immediately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Males and females 18 years of age or older
- •Hospitalized for COVID-19 with the most recent test positive*; not receiving or likely to receive invasive mechanical ventilation within the next 24 hours
- •Prior history of at least one of: i) CVD [cardiovascular (CV), cerebrovascular or peripheral vascular diagnoses], ii) Age > 64, iii) Diabetes (DM), iv) Hypertension (HTN), v) Abnormal serum lipids, vi) Obesity (BMI > or equal 30 or waist circumference >102 cm [40"] for men and >88 cm [35"] for women), vii) Current smoker
- •* Must be PCR test.
排除标准
- •Patients who have received vasopressors, extracorporeal membrane oxygenation and mechanical ventilation within last 30 days
- •Background of cardiac transplant surgery
- •Implanted defibrillator (ICD) in the last three months
- •Implanted left-ventricular assist device (LVAD)
- •Acute coronary syndrome (ACS) within 30 days
- •Percutaneous coronary intervention (PCI) within 30 days
- •Receiving any immuno-suppressive agent other than dexamethasone
- •History of QTc interval prolongation
- •QTc interval > 500 msec
- •Treated with strong inducers of CYP3A4 or CYP2C19
- •Chronic renal failure, determined as eGFR < 30 ml/min
- •Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN) or ALT or AST >3x ULN plus bilirubin >2x ULN
- •Bacterial sepsis, defined as documented bacteremia at the time of presentation or other active bacterial infection
- •Current participation in any research study involving investigational drugs or devices with the exception of dexamethasone, remdesivir, baricitinib plus remdesivir, convalescent plasma or monoclonal antibodies against the SARS-CoV-2 virus or any other therapy approved under emergency use in the region for treatment of COVID-19
- •Inability or unwillingness to give informed consent
- •Ongoing drug, alcohol or cannabis abuse
- •Women who are pregnant or breastfeeding
- •Any factor, which would make it unlikely that the patient can comply with the study procedures
- •Hemoglobin <8.5 gm/dL
- •Leukocyte count < 3000/ mm3
- •Platelets < 100,000 / mm3
- •Current diagnosis of cancer, with the exception of non-melanoma skin cancer
- •Showing suicidal tendency as per the Columbia-Suicide Severity Rating Scale (C-SSRS) administered at screening
- •Any cannabinoid intake in the past month
- •Body weight > 170 kg
研究组 & 干预措施
Cannabidiol, pharmaceutically produced with < 5 ppm THC
CardiolRx
干预措施: Cannabidiol, pharmaceutically produced with < 5 ppm THC (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Composite of All-cause Mortality, Requirement for ICU Admission and/or Ventillatory Support and Cardiovascular Complications
时间窗: 28 days post randomization
Proportions of patients in each group not having one of the outcome measures as described above (All-cause mortality, requirement for ICU admission and/or ventillatory support and cardiovascular complications)
All-cause Mortality
时间窗: 28 days post randomization
Proportions of patients not surviving
次要结局
- Ordinal Outcome Scale(28 days)