Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

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

NCT04858412 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DIETARY_SUPPLEMENT β-hydroxy β-methyl butyrate (HMB) enriched amino acid
  • DIETARY_SUPPLEMENT Balanced amino acid

Study Locations (1)

Ohio

  • Cleveland Clinic Foundation — Cleveland

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2021-04-01
Est. Completion 2026-12-31
Phase NA

Sponsor

The Cleveland Clinic

607 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04858412

The ClinicalTrials.gov registry entry for NCT04858412 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 607 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Alcoholic Liver Disease appearing as the primary indexed condition, and to 2 interventions — of which β-hydroxy β-methyl butyrate (HMB) enriched amino acid is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04858412 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04858412 about?

NCT04858412 is a clinical study titled "Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19". 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 m...

What is the current status of trial NCT04858412?

This trial is currently recruiting. It is a NA study. The enrollment target is 48 participants. The study started on 2021-04-01. Estimated completion is 2026-12-31.

What conditions does trial NCT04858412 study?

This clinical trial studies the following conditions: Alcoholic Liver Disease, COVID 19 Pneumonia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04858412?

The interventions under investigation include: β-hydroxy β-methyl butyrate (HMB) enriched amino acid (DIETARY_SUPPLEMENT), Balanced amino acid (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04858412?

This trial is sponsored by The Cleveland Clinic, which has 607 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04858412 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial