HMB supplementation for patients with alcoholic liver disease and COVID-19

Evaluate the Molecular Mechanisms of HMB-enriched Amino Acid Supplement to Reverse Muscle Loss in Patients With Alcoholic Liver Disease and COVID-19

This study is testing if HMB supplements can help people with alcoholic liver disease who also have COVID-19 feel better and recover more effectively.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT04858412 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of β-hydroxy β-methyl butyrate (HMB) enriched amino acid supplementation in patients suffering from alcoholic liver disease (ALD) who are also diagnosed with COVID-19 pneumonia. The research aims to understand the natural progression of COVID-19 in these patients and evaluate whether HMB can mitigate ventilatory deterioration and improve both short and long-term health outcomes. Patients will be monitored for changes in morbidity, mortality, and recovery from critical illness as a result of the intervention.

Who should consider this trial

Good fit: Ideal candidates include adults aged 21 and older with a diagnosis of alcoholic liver disease and COVID-19 pneumonia.

Not a fit: Patients who do not have alcoholic liver disease and are not experiencing COVID-19 pneumonia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve recovery and health outcomes for patients with both alcoholic liver disease and COVID-19.

How similar studies have performed: While the specific combination of HMB supplementation in this context is novel, similar studies have shown potential benefits of amino acid supplementation in critical illness.

Eligibility criteria

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

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Srinivasan Dasarathy, MD — Staff
• Study coordinator: Annette Bellar, MSLA

Conditions: Alcoholic Liver Disease, COVID 19 Pneumonia