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

NCT04858412 | Recruiting DMC

• 1 other identifier: 20-1194
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcoholic Liver Disease; COVID 19 Pneumonia

Outcome Measures

Primary Outcomes (2)

• Change in skeletal muscle mass at Day 0 and Day 90

  Baseline and Day 90

• Number of hospital admissions between Day 0 and Day 90

  Baseline and Day 90

Study Arms (2)

HMB enriched amino acid arm

ACTIVE COMPARATOR

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

Dietary Supplement: β-hydroxy β-methyl butyrate (HMB) enriched amino acid

Balanced amino acid arm

PLACEBO COMPARATOR

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

Dietary Supplement: Balanced amino acid

Interventions

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.

HMB enriched amino acid arm

Balanced amino acid DIETARY_SUPPLEMENT

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

Balanced amino acid arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Liver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Srinivasan Dasarathy, MD

  Staff

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annette Bellar, MSLA

CONTACT

216-445-0688; bellara@ccf.org

Alina Tuladhar, MPH

CONTACT

216-445-6268; tuladha@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: April 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)