Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorThe Cleveland Clinic
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
β-hydroxy β-methyl butyrate (HMB) enriched amino acid
Dietary supplementβ-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.
Balanced amino acid
Dietary supplementBalanced amino acid is the balanced mixture of the various essential amino acids.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: HMB enriched amino acid armActive comparator 1 intervention
Group B: Balanced amino acid armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in skeletal muscle mass at Day 0 and Day 90
Time frame
Baseline and Day 902
Number of hospital admissions between Day 0 and Day 90
Time frame
Baseline and Day 90Sponsors and contacts
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Source ClinicalTrials.gov