Recruiting

HMB with Amino Acids

Sponsor:

The Cleveland Clinic

Code:

NCT04858412

Conditions

Alcoholic Liver Disease

COVID 19 Pneumonia

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

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

Balanced amino acid

Study Details

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.

Conditions

Alcoholic Liver Disease

COVID 19 Pneumonia

Study ID

NCT04858412

Start date

Apr 1, 2021

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

placebo comparator: Balanced amino acid arm

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

Interventions

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

β-hydroxy β-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.

Primary outcome measure

  • Change in skeletal muscle mass at Day 0 and Day 90 [ Time Frame: Baseline and Day 90 ]
  • Number of hospital admissions between Day 0 and Day 90 [ Time Frame: Baseline and Day 90 ]

Central Contacts and Locations

Central contacts

Annette Bellar, MSLA

216-445-0688bellara@ccf.org

Alina Tuladhar, MPH

216-445-6268tuladha@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Annette Bellar, MSLA

216-445-0688bellara@ccf.org

Alina Tuladhar, MPH

216-445-6268tuladha@ccf.org

Principal Investigator:

Srinivasan Dasarathy, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-11-25.