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

Primary Purpose

Alcoholic Liver Disease, COVID 19 Pneumonia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
β-hydroxy β-methyl butyrate (HMB) enriched amino acid
Balanced amino acid
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcoholic Liver Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

HMB enriched amino acid arm

Balanced amino acid arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in skeletal muscle mass at Day 0 and Day 90
Number of hospital admissions between Day 0 and Day 90

Secondary Outcome Measures

Full Information

First Posted
April 21, 2021
Last Updated
February 8, 2023
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04858412
Brief Title
Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Liver Disease, COVID 19 Pneumonia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HMB enriched amino acid arm
Arm Type
Active Comparator
Arm Description
The patients randomized to the HMB enriched amino acid (HMB/EAA) arm will be given HMB/EAA for 90 days.
Arm Title
Balanced amino acid arm
Arm Type
Placebo Comparator
Arm Description
The patients randomized to the Balanced amino acid (BAA) arm will be given BAA for 90 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
β-hydroxy β-methyl butyrate (HMB) enriched amino acid
Intervention Description
β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.
Intervention Type
Dietary Supplement
Intervention Name(s)
Balanced amino acid
Intervention Description
Balanced amino acid is the balanced mixture of the various essential amino acids.
Primary Outcome Measure Information:
Title
Change in skeletal muscle mass at Day 0 and Day 90
Time Frame
Baseline and Day 90
Title
Number of hospital admissions between Day 0 and Day 90
Time Frame
Baseline and Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annette Bellar, MSLA
Phone
216-445-0688
Email
bellara@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Alina Tuladhar, MPH
Phone
216-445-6268
Email
tuladha@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srinivasan Dasarathy, MD
Organizational Affiliation
Staff
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annette Bellar, MSLA
Phone
216-445-0688
Email
bellara@ccf.org
First Name & Middle Initial & Last Name & Degree
Alina Tuladhar, MPH
Phone
216-445-6268
Email
tuladha@ccf.org
First Name & Middle Initial & Last Name & Degree
Srinivasan Dasarathy, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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