Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Evaluate the Molecular Mechanisms of HMB-enriched Amino Acid Supplement to Reverse Muscle Loss in Patients With Alcoholic Liver Disease and COVID-19

Conditions
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Alcoholic Liver Disease, COVID 19 Pneumonia

Intervention / Treatment
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* Dietary Supplement: β-hydroxy β-methyl butyrate (HMB) enriched amino acid
* Dietary Supplement: Balanced amino acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: (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 Pregnancy Unwillingness/ Inability to sign informed consent

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HMB enriched amino acid arm<br>The patients randomized to the HMB enriched amino acid (HMB/EAA) arm will be given HMB/EAA for 90 days. | Dietary Supplement: β-hydroxy β-methyl butyrate (HMB) enriched amino acid<br>* β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.<br>|
| Placebo Comparator: Balanced amino acid arm<br>The patients randomized to the Balanced amino acid (BAA) arm will be given BAA for 90 days. | Dietary Supplement: Balanced amino acid<br>* Balanced amino acid is the balanced mixture of the various essential amino acids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skeletal muscle mass at Day 0 and Day 90 |  | Baseline and Day 90 | 
| Number of hospital admissions between Day 0 and Day 90 |  | Baseline and Day 90 |