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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.