Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19
Eligible age
21+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this 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.
Sponsor: The Cleveland Clinic
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Cleveland
Source: ClinicalTrials.gov · NCT04858412 · last updated 2025-11-25