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Purpose

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

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
HMB enriched amino acid arm 		The patients randomized to the HMB enriched amino acid (HMB/EAA) arm will be given HMB/EAA for 90 days.
  • Dietary Supplement: β-hydroxy β-methyl butyrate (HMB) enriched amino acid
    β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.
Placebo Comparator
Balanced amino acid arm 		The patients randomized to the Balanced amino acid (BAA) arm will be given BAA for 90 days.
  • Dietary Supplement: Balanced amino acid
    Balanced amino acid is the balanced mixture of the various essential amino acids.

Recruiting Locations

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Annette Bellar, MSLA
216-445-0688
bellara@ccf.org

More Details

NCT ID
NCT04858412
Status
Recruiting
Sponsor
The Cleveland Clinic

Study Contact

Annette Bellar, MSLA
216-445-0688
bellara@ccf.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.