NCT04858412 Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19
| NCT ID | NCT04858412 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Alcoholic Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2021-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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
Contact & Investigator
Srinivasan Dasarathy, MD
PRINCIPAL INVESTIGATOR
Staff
Frequently Asked Questions
Who can join the NCT04858412 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Alcoholic Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04858412 currently recruiting?
Yes, NCT04858412 is actively recruiting participants. Contact the research team at bellara@ccf.org for enrollment information.
Where is the NCT04858412 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT04858412 clinical trial?
NCT04858412 is sponsored by The Cleveland Clinic. The principal investigator is Srinivasan Dasarathy, MD at Staff. The trial plans to enroll 48 participants.