What this study is
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.
What's being tested
- β-hydroxy β-methyl butyrate (HMB) enriched amino acid
Intervention · DIETARY SUPPLEMENT
β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.
- Balanced amino acid
Intervention · DIETARY SUPPLEMENT
Balanced amino acid is the balanced mixture of the various essential amino acids.
Study details
- Official title
- Evaluate the Molecular Mechanisms of HMB-enriched Amino Acid Supplement to Reverse Muscle Loss in Patients With Alcoholic Liver Disease and COVID-19
- Sponsor
- The Cleveland Clinic
- Conditions
- Alcoholic Liver Disease · COVID 19 Pneumonia
- Enrolling
- 48 people
- Starts
- 2021-04-01
- Est. completion
- 2028-12-31
- Design
- Quadruple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- A. Cases: Patients with ALD and COVID-19 pneumonia:
- Clinical, imaging, laboratory, and/or histological diagnosis of alcoholic cirrhosis and/or alcoholic hepatitis
- Child Pugh score 5-8, serum creatinine <3, Model for End Stage Liver Disease score (MELD) <25
- 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
- Age of 21 years or older B. Controls: Patients without alcoholic liver disease (Non-ALD) and COVID-19 pneumonia:
- 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
- Age of 21 years or older
You can't join if
- (Both Cases and Controls)
- Patients requiring active ventilator support
- 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),
- Recent gastrointestinal bleeding (<3 months)
- 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
- Medications that alter muscle protein metabolism except systemic corticosteroids
- Pregnancy
- Unwillingness/ Inability to sign informed consent
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCleveland Clinic Foundation
Cleveland, Ohio, United States
- Annette Bellar, MSLA · Contact216-445-0688bellara@ccf.org
- Alina Tuladhar, MPH · Contact216-445-6268tuladha@ccf.org
- Srinivasan Dasarathy, MD · Principal investigator
Recruiting
Study team
Sponsor
The Cleveland Clinic
Study ID 20-1194
Principal investigator
Srinivasan Dasarathy, MD
Staff
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.