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NCT04858412 · ClinicalTrials.gov registry record · NA

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

A NA study of COVID-19 Pneumonia and Alcoholic Liver Disease, sponsored by The Cleveland Clinic.

Recruiting
Registry status
NA
Development phase
48
Enrollment target
1
Study location

NCT04858412 is a NA study of COVID-19 Pneumonia and Alcoholic Liver Disease that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 48 participants, below the 254-participant average among 5 other COVID-19 Pneumonia trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04858412, a NA study of COVID-19 Pneumonia and Alcoholic Liver Disease, is actively recruiting participants, sponsored by The Cleveland Clinic.

RECRUITING
Registry status
NA
Development phase
48 participants
Enrollment target
1
Study location

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.

Conditions Studied

COVID-19 Pneumonia Alcoholic Liver Disease

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

688 total trials

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What the Registry Record Tells You About NCT04858412

The ClinicalTrials.gov registry entry for NCT04858412 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 254-participant average among 5 other COVID-19 Pneumonia trials with a reported enrollment target (81% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with COVID-19 Pneumonia 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.

NCT04858412 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

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: COVID-19 Pneumonia, Alcoholic Liver Disease.

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).

Who is sponsoring clinical trial NCT04858412?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.