Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: 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. |
Dietary Supplement: β-hydroxy β-methyl butyrate (HMB) enriched amino acid
β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.
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Placebo Comparator: Balanced amino acid arm The patients randomized to the Balanced amino acid (BAA) arm will be given BAA for 90 days. |
Dietary Supplement: Balanced amino acid
Balanced amino acid is the balanced mixture of the various essential amino acids.
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Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
A. Cases: Patients with ALD and COVID-19 pneumonia:
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Clinical, imaging, laboratory, and/or histological diagnosis of alcoholic cirrhosis and/or alcoholic hepatitis
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Child Pugh score 5-8, serum creatinine <3, Model for End Stage Liver Disease score (MELD) <25
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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
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Age of 21 years or older
B. Controls: Patients without alcoholic liver disease (Non-ALD) and COVID-19 pneumonia:
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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
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Age of 21 years or older
Exclusion Criteria: (Both Cases and Controls)
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Patients requiring active ventilator support
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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),
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Recent gastrointestinal bleeding (<3 months)
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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
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Medications that alter muscle protein metabolism except systemic corticosteroids
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Pregnancy
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Unwillingness/ Inability to sign informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- The Cleveland Clinic
Investigators
- Principal Investigator: Srinivasan Dasarathy, MD, Staff
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-1194