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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

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
The Cleveland Clinic

688 total trials

What NCT04858412 shows while recruiting

NCT04858412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 254-participant average among 5 other COVID-19 Pneumonia trials with a reported enrollment target (81% lower).

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 a single indexed study location in 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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Source: ClinicalTrials.gov NCT04858412, the US trial registry maintained by the National Library of Medicine. NCT04858412 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.