Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcoholic Liver Disease COVID 19 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HMB enriched amino acid arm

The patients randomized to the HMB enriched amino acid (HMB/EAA) arm will be given HMB/EAA for 90 days.

Group Type ACTIVE_COMPARATOR

β-hydroxy β-methyl butyrate (HMB) enriched amino acid

Intervention Type DIETARY_SUPPLEMENT

β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.

Balanced amino acid arm

The patients randomized to the Balanced amino acid (BAA) arm will be given BAA for 90 days.

Group Type PLACEBO_COMPARATOR

Balanced amino acid

Intervention Type DIETARY_SUPPLEMENT

Balanced amino acid is the balanced mixture of the various essential amino acids.

Interventions

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β-hydroxy β-methyl butyrate (HMB) enriched amino acid

β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.

Intervention Type DIETARY_SUPPLEMENT

Balanced amino acid

Balanced amino acid is the balanced mixture of the various essential amino acids.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No