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

Sponsor
The Cleveland Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04858412
Collaborator
(none)
48
1
2
24
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: β-hydroxy β-methyl butyrate (HMB) enriched amino acid
  • Dietary Supplement: Balanced amino acid
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

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.

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

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

Outcome Measures

Primary Outcome Measures

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

  2. Number of hospital admissions between Day 0 and Day 90 [Baseline and Day 90]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cleveland Clinic Foundation Cleveland Ohio United States 44195

Sponsors and Collaborators

  • The Cleveland Clinic

Investigators

  • Principal Investigator: Srinivasan Dasarathy, MD, Staff

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Srinivasan Dasarathy, Staff, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT04858412
Other Study ID Numbers:
  • 20-1194
First Posted:
Apr 26, 2021
Last Update Posted:
Mar 14, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2022