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

Alcoholic Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04858412
• Other study ID #: 20-1194
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: The Cleveland Clinic
• Contact: Annette Bellar, MSLA
• Phone: 216-445-0688
• Email: bellara[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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: (Both Cases and Controls)

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

Related Conditions & MeSH terms

• Alcoholic Liver Disease
• COVID 19 Pneumonia
• COVID-19
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in skeletal muscle mass at Day 0 and Day 90		Baseline and Day 90
Primary	Number of hospital admissions between Day 0 and Day 90		Baseline and Day 90