Efficacy and Safety of Acetyl L-Carnitine in COVID-19 Patients With Mild-to-Moderate Disease
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ClinicalTrials.gov Identifier: NCT04623619 |
Recruitment Status : Unknown
Verified November 2020 by Antonio Cascio, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo.
Recruitment status was: Not yet recruiting
First Posted : November 10, 2020
Last Update Posted : November 17, 2020
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Different studies showed that acetyl L-Carnitine (LC) positively affects the development and maturation of T lymphocytes, involved in the immune response to viral agents. It also contributes to the inhibition of ROS production and to the remodulation of the cytokine network typical of the systemic inflammatory syndrome.
Given the potential protective effects of LC, it is suggested as a supportive and therapeutic option in patients with coronavirus infection. Given this background, in the light of the current COVID-19 emergency, it is the intention of the investigators to conduct a prospective, randomized, open-label, controlled study in the cohort of hospitalized patients with covid-19 pneumonia, administering 2 gr of LC orally in addition to the standard of care therapy (SOC).
The investigators hypothesize that the use of LC will be associated with an earlier improvement of clinical and biohumoral parameters after 14 days of LC treatment when compared to the group of patients provided with standard care.
Condition or disease | Intervention/treatment | Phase |
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Covid19 | Dietary Supplement: Acetyl L-Carnitine | Not Applicable |
Different studies showed that acetyl L-Carnitine (LC) positively affects the development and maturation of T lymphocytes, involved in the immune response to viral agents. It also contributes to the inhibition of ROS production and to the remodulation of the cytokine network typical of the systemic inflammatory syndrome.
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. LC can be beneficial to the antioxidant effects of Angiotensin II by inhibiting NF-kB and down-regulating NOX1and NOX2. For LC, an anti-apoptotic and genome-stabilizer role was estimated by inhibiting pro-apoptotic caspases and activating PARP-1. LC is an immunomodulator that downregulates pro-inflammatory cytokines including TNF-α, IL-6, and IL-1 that could extinguish the cytokine storm. LC can also serve as a protective agent against COVID19 cardiotoxicity due to disruption in the ACE2-mediated signaling pathway, cytokine storm, pulmonary dysfunction, and side effects of medications.
In patients with coronavirus infection, provided LC's possible protective effects, it is suggested as a supportive and therapeutic alternative.
Given this background, in the light of the current COVID-19 emergency, it is the intention of the investigators to conduct a prospective, randomized, open-label, controlled study in the cohort of hospitalized patients with covid-19 pneumonia, administering 2 gr of LC orally in addition to the standard of care therapy (SOC).
The investigators hypothesize that the use of LC will be associated with an earlier improvement of clinical and humoral parameters after 14 days of LC treatment when compared to the group of patients provided with standard care.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Prospective, randomized, open-label, controlled study |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Use of Acetyl L-Carnitine in Patients With Covid-19 Pneumonia |
Estimated Study Start Date : | December 15, 2020 |
Estimated Primary Completion Date : | April 29, 2021 |
Estimated Study Completion Date : | July 31, 2021 |

Arm | Intervention/treatment |
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Experimental: Acetyl L-Carnitine
Acetyl L-Carnitine
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Dietary Supplement: Acetyl L-Carnitine
Administering 2 gr of Acetyl L-Carnitine orally in addition to the standard of care therapy for 14 days |
No Intervention: Standard of care
Standard of care
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- In-hospital mortality [ Time Frame: 72 hours ]Change of hospital mortality
- C reactive protein (CRP) levels [ Time Frame: 72 hours ]Reduction of CRP levels > 50% in comparison with CRP levels at the admission, within 72 hours after the administration
- IL-6 levels [ Time Frame: 72 hours ]Reduction of IL-6 levels > 50% in comparison with IL-6 at the admission, within 72 hours after the administration
- D-dimer levels [ Time Frame: 72 hours ]Reduction of D-dimer levels > 50% in comparison with D-dimer at the admission, within 72 hours after the administration
- Hospital stay [ Time Frame: up to 24 weeks ]Length of hospital stay
- Duration of positive PCR swab [ Time Frame: 5 days ]Time length of negativization of PCR molecular swab

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Positive swab test of SARS-CoV-2
- Pneumonia related to SARS-CoV-2
- Signature of informed consent
Exclusion Criteria:
- Unsigned informed consent
- Negative swab test of SARS-CoV-2

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04623619
Contact: Antonio Cascio, MD, PhD | 3389912198 | antonio.cascio03@unipa.it |
Principal Investigator: | Antonio Cascio, MD, PhD | University of Palermo, Italy |
Responsible Party: | Antonio Cascio, Direttore UOC Malattie Infettive e Tropicali, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo |
ClinicalTrials.gov Identifier: | NCT04623619 |
Other Study ID Numbers: |
20201109 |
First Posted: | November 10, 2020 Key Record Dates |
Last Update Posted: | November 17, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
acetyl L-Carnitine |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Acetylcarnitine Vitamin B Complex Vitamins Micronutrients Physiological Effects of Drugs Nootropic Agents |