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NCT Number: NCT04858412

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

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.

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

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

Balanced amino acid

Dietary Supplement

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

Primary outcomes

  1. Change in skeletal muscle mass at Day 0 and Day 90

    Time frame: Baseline and Day 90

  2. Number of hospital admissions between Day 0 and Day 90

    Time frame: Baseline and Day 90

Study contacts

Contact information is provided by the study sponsor or research team.

Alina Tuladhar, MPH

CONTACT

[email protected]

216-445-6268

Annette Bellar, MSLA

CONTACT

[email protected]

216-445-0688

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2021
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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