Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19
Evaluate the Molecular Mechanisms of HMB-enriched Amino Acid Supplement to Reverse Muscle Loss in Patients With Alcoholic Liver Disease and COVID-19
The Cleveland Clinic
48 participants
Apr 1, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria7
- 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
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Interventions
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.
Locations(1)
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NCT04858412