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Recruiting NCT04858412

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

No phase Interventional Alcoholic Liver Disease COVID 19 Pneumonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: β-hydroxy β-methyl butyrate (HMB) enriched amino acid, Balanced amino acid.
Who it may be relevant to
Registry conditions: Alcoholic Liver Disease, COVID 19 Pneumonia. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluate the Molecular Mechanisms of HMB-enriched Amino Acid Supplement to Reverse Muscle Loss in Patients With Alcoholic Liver Disease and COVID-19

Overview

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.

Interventions

  • Dietary supplement β-hydroxy β-methyl butyrate (HMB) enriched amino acid
    β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.
  • Dietary supplement Balanced amino acid
    Balanced amino acid is the balanced mixture of the various essential amino acids.

Primary outcome measures

  • Change in skeletal muscle mass at Day 0 and Day 90 [Time frame: Baseline and Day 90]
  • Number of hospital admissions between Day 0 and Day 90 [Time frame: Baseline and Day 90]

Eligibility criteria

Inclusion criteria

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 Criteria: (Both Cases and Controls)

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Cleveland Clinic Foundation — Cleveland

Identifiers

NCT: NCT04858412 · 20-1194

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗