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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Srinivasan Dasarathy, MD — Staff
• Study coordinator: Annette Bellar, MSLA
• Email: bellara@ccf.org
• Phone: 216-445-0688

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.