Evaluate the Molecular Mechanisms of HMB-enriched Amino Acid Supplement to Reverse Muscle Loss in Patients With Alcoholic Liver Disease and COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in skeletal muscle mass at Day 0 and Day 90
研究概览
简要总结
Patients with COVID-19 and comorbidities including alcohol associated liver disease (ALD) are at risk for severe illness and abrupt or sudden clinical deterioration with ventilatory failure. â-hydroxy â-methyl butyrate (HMB), a non-nitrogenous leucine metabolite with anabolic properties, increases muscle mass and contractile function and enhances immune function. We aim to study the natural course of COVID-19 in patients with ALD and test whether HMB can affect ventilatory deterioration and improve short and long-term morbidity, mortality, and recovery from critical illness in symptomatic COVID-19 patients with ALD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Cases: Patients with ALD and COVID-19 pneumonia:
- •Clinical, imaging, laboratory, and/or histological diagnosis of alcoholic cirrhosis and/or alcoholic hepatitis
- •Child Pugh score 5-8, serum creatinine <3, Model for End Stage Liver Disease score (MELD) <25
- •Diagnosis of COVID-19 pneumonia as defined by the WHO criteria: confirmed SARS-CoV-2 infection by PCR, evidence of bilateral pulmonary infiltrates on chest radiograph (CXR) or computed tomography (CT) and SpO2 <93% or on oxygen supplement
- •Age of 21 years or older
- •B. Controls: Patients without alcoholic liver disease (Non-ALD) and COVID-19 pneumonia:
- •Diagnosis of COVID-19 pneumonia as defined by the WHO criteria: confirmed SARS-CoV-2 infection by PCR, evidence of bilateral pulmonary infiltrates on chest radiograph (CXR) or computed tomography (CT) and SpO2 <93% or on oxygen supplement
- •Age of 21 years or older
排除标准
- •(Both Cases and Controls)
- •Patients requiring active ventilator support
- •Anticoagulant/antiplatelet therapy (for those in the biopsy arm, see Randomization schema. If clinically feasible, patients will be asked to hold their anticoagulants for the muscle biopsy after physician review),
- •Recent gastrointestinal bleeding (<3 months)
- •Advanced organ diseases: congestive heart failure (NYHA class 3 and 4), chronic obstructive pulmonary diseases (COPD) (GOLD stage 3 and 4), chronic kidney disease (Cr>3), metastatic malignancy
- •Medications that alter muscle protein metabolism except systemic corticosteroids
- •Unwillingness/ Inability to sign informed consent
研究组 & 干预措施
HMB enriched amino acid arm
The patients randomized to the HMB enriched amino acid (HMB/EAA) arm will be given HMB/EAA for 90 days.
干预措施: β-hydroxy β-methyl butyrate (HMB) enriched amino acid (Dietary Supplement)
Balanced amino acid arm
The patients randomized to the Balanced amino acid (BAA) arm will be given BAA for 90 days.
干预措施: Balanced amino acid (Dietary Supplement)
结局指标
主要结局
Change in skeletal muscle mass at Day 0 and Day 90
时间窗: Baseline and Day 90
Number of hospital admissions between Day 0 and Day 90
时间窗: Baseline and Day 90
次要结局
未报告次要终点
研究者
Srinivasan Dasarathy
Staff
The Cleveland Clinic