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

NCT04623619 | Unknown DMC

• 1 other identifier: 20201109
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Covid19

Keywords

acetyl L-Carnitine

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  Change of hospital mortality

  72 hours

Secondary Outcomes (5)

• C reactive protein (CRP) levels

  72 hours

• IL-6 levels

  72 hours

• D-dimer levels

  72 hours

• Hospital stay

  up to 24 weeks

• Duration of positive PCR swab

  5 days

Study Arms (2)

Acetyl L-Carnitine

EXPERIMENTAL

Acetyl L-Carnitine

Dietary Supplement: Acetyl L-Carnitine

Standard of care

NO INTERVENTION

Standard of care

Interventions

Acetyl L-Carnitine DIETARY_SUPPLEMENT

Administering 2 gr of Acetyl L-Carnitine orally in addition to the standard of care therapy for 14 days

Acetyl L-Carnitine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive swab test of SARS-CoV-2
• Pneumonia related to SARS-CoV-2
• Signature of informed consent

You may not qualify if:

• Unsigned informed consent
• Negative swab test of SARS-CoV-2

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: lead

Related Publications (7)

• Blanca AJ, Ruiz-Armenta MV, Zambrano S, Miguel-Carrasco JL, Gonzalez-Roncero FM, Fortuno A, Revilla E, Mate A, Vazquez CM. l-Carnitine ameliorates the oxidative stress response to angiotensin II by modulating NADPH oxidase through a reduction in protein kinase c activity and NF-kappaB translocation to the nucleus. Food Chem. 2017 Aug 1;228:356-366. doi: 10.1016/j.foodchem.2017.02.011. Epub 2017 Feb 6.

  PMID: 28317735 BACKGROUND

• Puskarich MA, Kline JA, Krabill V, Claremont H, Jones AE. Preliminary safety and efficacy of L-carnitine infusion for the treatment of vasopressor-dependent septic shock: a randomized control trial. JPEN J Parenter Enteral Nutr. 2014 Aug;38(6):736-43. doi: 10.1177/0148607113495414. Epub 2013 Jul 12.

  PMID: 23851424 BACKGROUND

• Diao B, Wang C, Tan Y, Chen X, Liu Y, Ning L, Chen L, Li M, Liu Y, Wang G, Yuan Z, Feng Z, Zhang Y, Wu Y, Chen Y. Reduction and Functional Exhaustion of T Cells in Patients With Coronavirus Disease 2019 (COVID-19). Front Immunol. 2020 May 1;11:827. doi: 10.3389/fimmu.2020.00827. eCollection 2020.

  PMID: 32425950 BACKGROUND

• Moretti S, Alesse E, Di Marzio L, Zazzeroni F, Ruggeri B, Marcellini S, Famularo G, Steinberg SM, Boschini A, Cifone MG, De Simone C. Effect of L-carnitine on human immunodeficiency virus-1 infection-associated apoptosis: a pilot study. Blood. 1998 May 15;91(10):3817-24.

  PMID: 9573019 BACKGROUND

• Wang ZY, Liu YY, Liu GH, Lu HB, Mao CY. l-Carnitine and heart disease. Life Sci. 2018 Feb 1;194:88-97. doi: 10.1016/j.lfs.2017.12.015. Epub 2017 Dec 11.

  PMID: 29241711 BACKGROUND

• Mohammadi M, Hajhossein Talasaz A, Alidoosti M. Preventive effect of l-carnitine and its derivatives on endothelial dysfunction and platelet aggregation. Clin Nutr ESPEN. 2016 Oct;15:1-10. doi: 10.1016/j.clnesp.2016.06.009. Epub 2016 Jun 27.

  PMID: 28531771 BACKGROUND

• Gorlinger K, Dirkmann D, Gandhi A, Simioni P. COVID-19-Associated Coagulopathy and Inflammatory Response: What Do We Know Already and What Are the Knowledge Gaps? Anesth Analg. 2020 Nov;131(5):1324-1333. doi: 10.1213/ANE.0000000000005147.

  PMID: 33079850 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Acetylcarnitine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Antonio Cascio, MD, PhD

  University of Palermo, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Cascio, MD, PhD

CONTACT

3389912198; antonio.cascio03@unipa.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Direttore UOC Malattie Infettive e Tropicali

Model Details: Prospective, randomized, open-label, controlled study

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 10, 2020
• Study Start: December 15, 2020
• Primary Completion: April 29, 2021
• Study Completion: July 31, 2021
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share