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Efficacy and Safety of Acetyl L-Carnitine in COVID-19 Patients With Mild-to-Moderate Disease

Plain-language guide to NCT04623619: not phased randomized trial of L-Carnitine, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04623619
Phase
not phased
Status
status unknown
Start
2020-12-15
Completion (planned or actual)
2021-04-29
Participants
100 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Covid19
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test L-Carnitine.

It also contributes to the inhibition of ROS production and to the remodulation of the cytokine network typical of the systemic inflammatory syndrome.

It had two arms (groups): Acetyl L-Carnitine (experimental) and Standard of care (no intervention).

Acetyl L-Carnitine.

Standard of care.

The registry classes the interventions as dietary supplement.

More on the Plan

SARS-CoV-2 virus activates the human cell ACE2 receptor, triggering a series of deleterious events.

In COVID19, renin-angiotensin is upregulated and the pathway is overexpressed and a progressive cytokine storm is always observed.

In all these pathogenic processes, LC could play a modifier function to enhance condition.

For LC, an anti-apoptotic and genome-stabilizer role was estimated by inhibiting pro-apoptotic caspases and activating PARP-1.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Positive swab test of SARS-CoV-2. Pneumonia related to SARS-CoV-2. Signature of informed consent.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: unsigned informed consent; negative swab test of sars-cov-2.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Being open-label, the L-Carnitine study did not mask who received what.

It started in 2020-12-15 with completion listed for 2021-04-29.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): In-hospital mortality (time frame: 72 hours).

It also tracked 5 secondary outcomes, for example C reactive protein (CRP) levels, IL-6 levels, D-dimer levels, Hospital stay and Duration of positive PCR swab.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.

Our Notes on the Compound

L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.