Alcoholic Liver DiseaseNCT04858412
Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19
A study testing β-hydroxy β-methyl butyrate (HMB) enriched amino acid and Balanced amino acid in people with Alcoholic Liver Disease and COVID 19 Pneumonia, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcoholic Liver Disease, COVID 19 Pneumonia
- What is being tested?
- β-hydroxy β-methyl butyrate (HMB) enriched amino acid and Balanced amino acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Annette Bellar, MSLA, 216-445-0688, bellara@ccf.org
Alina Tuladhar, MPH, 216-445-6268, tuladha@ccf.org
About this study
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
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
- Being tested
- β-hydroxy β-methyl butyrate (HMB) enriched amino acid, Balanced amino acid
- Medical subject headings
- Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β-hydroxy β-methyl butyrate (HMB) enriched amino acidDietary supplement
β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.
Balanced amino acidDietary supplement
Balanced amino acid is the balanced mixture of the various essential amino acids.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Balanced amino acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skeletal muscle mass at Day 0 and Day 90
Measured: Baseline and Day 90
Number of hospital admissions between Day 0 and Day 90
Measured: Baseline and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinivasan Dasarathy, The Cleveland Clinic
- Investigators
- Srinivasan Dasarathy, MD, Principal investigator, Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858412
- Sponsor's protocol ID
- 20-1194
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04858412
- Acronym / sponsor ID
- 20-1194
- Conditions
- Alcoholic Liver Disease, COVID 19 Pneumonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMB enriched amino acid arm | Active comparator | Dietary Supplement: β-hydroxy β-methyl butyrate (HMB) enriched amino acidThe patients randomized to the HMB enriched amino acid (HMB/EAA) arm will be given HMB/EAA for 90 days. |
| Balanced amino acid arm | Placebo comparator | Dietary Supplement: Balanced amino acidThe patients randomized to the Balanced amino acid (BAA) arm will be given BAA for 90 days. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| β-hydroxy β-methyl butyrate (HMB) enriched amino acidβ-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties. | Dietary supplement | HMB enriched amino acid arm |
| Balanced amino acidBalanced amino acid is the balanced mixture of the various essential amino acids. | Dietary supplement | Balanced amino acid arm |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Srinivasan Dasarathy, MD principal investigator
Staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing β-hydroxy β-methyl butyrate (HMB) enriched amino acid and Balanced amino acid in people with Alcoholic Liver Disease and COVID 19 Pneumonia, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annette Bellar, MSLA (216-445-0688, bellara@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skeletal muscle mass at Day 0 and Day 90 (time frame: Baseline and Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.