[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100428390":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":65,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":26,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HMB enriched amino acid arm","ACTIVE_COMPARATOR","The patients randomized to the HMB enriched amino acid (HMB\u002FEAA) arm will be given HMB\u002FEAA for 90 days.",[13],"Dietary Supplement: β-hydroxy β-methyl butyrate (HMB) enriched amino acid",{"label":15,"type":16,"description":17,"interventionNames":18},"Balanced amino acid arm","PLACEBO_COMPARATOR","The patients randomized to the Balanced amino acid (BAA) arm will be given BAA for 90 days.",[19],"Dietary Supplement: Balanced amino acid",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Balanced amino acid","Balanced amino acid is the balanced mixture of the various essential amino acids.",[15],[32],{"name":33,"affiliation":34,"role":35},"Srinivasan Dasarathy, MD","Staff","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Annette Bellar, MSLA","CONTACT","216-445-0688","bellara@ccf.org",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Alina Tuladhar, MPH","216-445-6268","tuladha@ccf.org",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Cleveland Clinic Foundation","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-81.69541,41.4995,{"lat":59,"lon":58},[62,63,64],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":35,"investigatorFullName":66,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Srinivasan Dasarathy","100428390","study-of-hmb-enriched-amino-acid-supplementation-in-patients-with-alcoholic-liver-disease-and-covid-19-100428390",false,"NCT04858412","Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19","Evaluate the Molecular Mechanisms of HMB-enriched Amino Acid Supplement to Reverse Muscle Loss in Patients With Alcoholic Liver Disease and COVID-19","Inclusion Criteria:\n\nA. Cases: Patients with ALD and COVID-19 pneumonia:\n\n1. Clinical, imaging, laboratory, and\u002For histological diagnosis of alcoholic cirrhosis and\u002For alcoholic hepatitis\n2. Child Pugh score 5-8, serum creatinine \\\u003C3, Model for End Stage Liver Disease score (MELD) \\\u003C25\n3. 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 \\\u003C93% or on oxygen supplement\n4. Age of 21 years or older\n\nB. Controls: Patients without alcoholic liver disease (Non-ALD) and COVID-19 pneumonia:\n\n1. 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 \\\u003C93% or on oxygen supplement\n2. Age of 21 years or older\n\nExclusion Criteria: (Both Cases and Controls)\n\n1. Patients requiring active ventilator support\n2. Anticoagulant\u002Fantiplatelet 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),\n3. Recent gastrointestinal bleeding (\\\u003C3 months)\n4. 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\n5. Medications that alter muscle protein metabolism except systemic corticosteroids\n6. Pregnancy\n7. Unwillingness\u002F Inability to sign informed consent","ALL","21 Years",{"count":77,"type":78},48,"ESTIMATED","INTERVENTIONAL",[81],"NA","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.",[84,85],"Alcoholic Liver Disease","COVID 19 Pneumonia","2025-11-24",{"date":88,"type":89},"2025-11-25","ACTUAL",{"date":91,"type":89},"2021-04-01",{"date":93,"type":78},"2026-12-31",{"name":5,"class":6},1]