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Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 31, 2026 → Dec 31, 2028
See other at-risk trials from The Cleveland Clinic

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 31, 2026 to Dec 31, 2028
    • Eligibility criteria shortened, about 14 words
  2. 2 versions Re-verified since Jan 8, 2025, no change to tracked fieldsv6-v7
  3. Primary and study completion dates: Mar 31, 2025 to Dec 31, 2026v5
  4. Re-verified, no change to tracked fieldsv4
  5. Primary and study completion dates: Mar 31, 2023 to Mar 31, 2025v3
  6. Primary and study completion dates: Mar 31, 2022 to Mar 31, 2023v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04858412
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)		 Alcoholic Liver Disease, COVID 19 Pneumonia
Related terms Liver Diseases, Alcoholic
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov