Actively Recruiting
Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19
Led by The Cleveland Clinic · Updated on 2025-11-25
48
Participants Needed
1
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with alcoholic liver disease and COVID-19 pneumonia confirmed by clinical, imaging, laboratory, or histological diagnosis
- Child Pugh score between 5 and 8, serum creatinine less than 3, and MELD score less than 25
- Diagnosis of COVID-19 pneumonia confirmed by PCR with bilateral lung infiltrates and oxygen saturation below 93% or need for oxygen
- Age 21 years or older
- Controls: Patients with COVID-19 pneumonia without alcoholic liver disease
- Age 21 years or older
You will not qualify if you...
- Patients requiring active ventilator support
- Use of anticoagulant or antiplatelet therapy (for biopsy arm, may need to hold therapy after physician review)
- Recent gastrointestinal bleeding within the past 3 months
- Advanced organ diseases including congestive heart failure (NYHA class 3 or 4), severe COPD (GOLD stage 3 or 4), chronic kidney disease with creatinine above 3, or metastatic cancer
- Use of medications that alter muscle protein metabolism except systemic corticosteroids
- Pregnancy
- Unwillingness or inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
A
Annette Bellar, MSLA
CONTACT
A
Alina Tuladhar, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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