Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19
Launched by THE CLEVELAND CLINIC · Apr 21, 2021
Trial Information
Current as of July 24, 2025
Recruiting
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
About The Cleveland Clinic
The Cleveland Clinic is a renowned nonprofit academic medical center based in Cleveland, Ohio, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, the Cleveland Clinic leverages its multidisciplinary expertise and state-of-the-art facilities to conduct groundbreaking studies aimed at improving patient outcomes across a wide range of medical conditions. With a strong emphasis on patient-centered care, the institution fosters collaboration among researchers, clinicians, and patients to explore new treatments and therapies, contributing significantly to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Patients applied
Trial Officials
Srinivasan Dasarathy, MD
Principal Investigator
Staff
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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