Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19
Evaluate the Molecular Mechanisms of HMB-enriched Amino Acid Supplement to Reverse Muscle Loss 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alina Tuladhar, MPH
- Phone Number: 216-445-6268
- Email: tuladha@ccf.org
Study Contact Backup
- Name: Annette Bellar, MSLA
- Phone Number: 216-445-0688
- Email: bellara@ccf.org
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic Foundation
-
Contact:
- Alina Tuladhar, MPH
- Phone Number: 216-445-6268
- Email: tuladha@ccf.org
-
Principal Investigator:
- Srinivasan Dasarathy, MD
-
Contact:
- Annette Bellar, MSLA
- Phone Number: 216-445-0688
- Email: bellara@ccf.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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. |
β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties. |
|
Placebo Comparator: Balanced amino acid arm
The patients randomized to the Balanced amino acid (BAA) arm will be given BAA for 90 days. |
Balanced amino acid is the balanced mixture of the various essential amino acids. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in skeletal muscle mass at Day 0 and Day 90
Time Frame: Baseline and Day 90
|
Baseline and Day 90
|
|
Number of hospital admissions between Day 0 and Day 90
Time Frame: Baseline and Day 90
|
Baseline and Day 90
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Srinivasan Dasarathy, MD, Staff
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-1194
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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