An interventional study of β-hydroxy β-methyl butyrate (HMB) enriched amino acid and Balanced amino acid in Alcoholic Liver Disease and COVID 19 Pneumonia, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Basic science
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.
Inclusion Criteria:
A. Cases: Patients with ALD and COVID-19 pneumonia:
B. Controls: Patients without alcoholic liver disease (Non-ALD) and COVID-19 pneumonia:
Exclusion Criteria: (Both Cases and Controls)
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
The patients randomized to the Balanced amino acid (BAA) arm will be given BAA for 90 days.
Dietary Supplement: Balanced amino acid
β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.
Balanced amino acid is the balanced mixture of the various essential amino acids.
Change in skeletal muscle mass at Day 0 and Day 90
Time frame: Baseline and Day 90
Number of hospital admissions between Day 0 and Day 90
Time frame: Baseline and Day 90
Plan to share: No
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