Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 and older
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
48 (estimated)
Sponsor
The Cleveland Clinic · Other
Who this trial is looking for
This trial is looking for patients who have both alcoholic liver disease and COVID-19 pneumonia. Participants will receive a supplement called HMB to see if it helps improve their condition and recovery.
Are You a Good Fit for This Trial?
Rules you outSevere heart failureSevere COPDChronic kidney diseaseMetastatic malignancy
You may be able to join if
I have been diagnosed with alcoholic cirrhosis or alcoholic hepatitis.
I have a Child Pugh score between 5 and 8.
I have been diagnosed with COVID-19 pneumonia.
I am 21 years or older.
You may not be able to join if
I require active ventilator support.
I have had recent gastrointestinal bleeding.
I have advanced organ diseases like heart failure or severe COPD.
I am pregnant.
I am unable to sign informed consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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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 …
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
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