Study of HMB-enriched Amino Acid Supplementation in Patie... | NCT04858412

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

NCT04858412

Sponsor

The Cleveland Clinic

Status

Recruiting

Last Update Posted

Nov 25, 2025Actual

Enrollment

48Estimated

Phase

Not Applicable

Conditions

Alcoholic Liver Disease
COVID 19 Pneumonia

Interventions

β-hydroxy β-methyl butyrate (HMB) enriched amino acid
Balanced amino acid

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Apr 21, 2021

First Submission Date that Met QC Criteria

Apr 21, 2021

First Posted Date

Apr 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2025

Last Update Posted Date

Nov 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Annette Bellar, MSLA	Contact	216-445-0688		bellara@ccf.org
Alina Tuladhar, MPH	Contact	216-445-6268		tuladha@ccf.org

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D020751	Alcohol-Induced Disorders
D019973	Alcohol-Related Disorders