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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
Who can join
Ages 21 and older · All sexes
Full eligibility criteria
Inclusion Criteria: A. Cases: Patients with ALD and COVID-19 pneumonia: 1. Clinical, imaging, laboratory, and/or histological diagnosis of alcoholic cirrhosis and/or alcoholic hepatitis 2. Child Pugh score 5-8, serum creatinine \<3, Model for End Stage Liver Disease score (MELD) \<25 3. 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 4. Age of 21 years or older B. Controls: Patients without alcoholic liver disease (Non-ALD) and COVID-19 pneumonia: 1. 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 2. Age of 21 years or older Exclusion Criteria: (Both Cases and Controls) 1. Patients requiring active ventilator support 2. 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), 3. Recent gastrointestinal bleeding (\<3 months) 4. 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 5. Medications that alter muscle protein metabolism except systemic corticosteroids 6. Pregnancy 7. Unwillingness/ Inability to sign informed consent
About the study
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.
What is being tested
- β-hydroxy β-methyl butyrate (HMB) enriched amino acid (dietary supplement)
- Balanced amino acid (dietary supplement)
Sponsor: The Cleveland Clinic · Participants: 48 · Started: Apr 1, 2021
Contact the study team
- Annette Bellar, MSLA · Phone: 216-445-0688
- Alina Tuladhar, MPH · Phone: 216-445-6268
Official record on ClinicalTrials.gov — NCT04858412
Locations in the U.S.
| Ohio | Cleveland Clinic Foundation, Cleveland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.