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

Launched by THE CLEVELAND CLINIC · Apr 21, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how a special supplement called HMB can help patients who have both alcoholic liver disease (ALD) and COVID-19 pneumonia. HMB is thought to support muscle growth and improve immune function, which might be important for patients at risk of serious complications from COVID-19. The researchers want to see if taking HMB can help these patients recover better and faster, potentially reducing their chances of getting worse or needing ventilation support.

To participate in the trial, patients must be at least 21 years old and diagnosed with COVID-19 pneumonia and alcoholic liver disease, which can be determined through medical tests and imaging. The study is open to both patients with ALD and those without it who have COVID-19 pneumonia. Unfortunately, patients who are on ventilators or have certain other health issues won't be eligible. If someone joins the study, they will be closely monitored to track their health and response to the HMB supplement. This could provide valuable information about the treatment's potential benefits for this vulnerable group of patients.

Gender

ALL

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