Efficacy and Safety of Acetyl L-Carnitine in COVID-19 Patients With Mild-to-Moderate Disease
Primary Purpose
Covid19
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acetyl L-Carnitine
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring acetyl L-Carnitine
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acetyl L-Carnitine
Standard of care
Arm Description
Acetyl L-Carnitine
Standard of care
Outcomes
Primary Outcome Measures
In-hospital mortality
Change of hospital mortality
Secondary Outcome Measures
C reactive protein (CRP) levels
Reduction of CRP levels > 50% in comparison with CRP levels at the admission, within 72 hours after the administration
IL-6 levels
Reduction of IL-6 levels > 50% in comparison with IL-6 at the admission, within 72 hours after the administration
D-dimer levels
Reduction of D-dimer levels > 50% in comparison with D-dimer at the admission, within 72 hours after the administration
Hospital stay
Length of hospital stay
Duration of positive PCR swab
Time length of negativization of PCR molecular swab
Full Information
NCT ID
NCT04623619
First Posted
November 9, 2020
Last Updated
November 15, 2020
Sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
1. Study Identification
Unique Protocol Identification Number
NCT04623619
Brief Title
Efficacy and Safety of Acetyl L-Carnitine in COVID-19 Patients With Mild-to-Moderate Disease
Official Title
Use of Acetyl L-Carnitine in Patients With Covid-19 Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2020 (Anticipated)
Primary Completion Date
April 29, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
acetyl L-Carnitine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, open-label, controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acetyl L-Carnitine
Arm Type
Experimental
Arm Description
Acetyl L-Carnitine
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Dietary Supplement
Intervention Name(s)
Acetyl L-Carnitine
Intervention Description
Administering 2 gr of Acetyl L-Carnitine orally in addition to the standard of care therapy for 14 days
Primary Outcome Measure Information:
Title
In-hospital mortality
Description
Change of hospital mortality
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
C reactive protein (CRP) levels
Description
Reduction of CRP levels > 50% in comparison with CRP levels at the admission, within 72 hours after the administration
Time Frame
72 hours
Title
IL-6 levels
Description
Reduction of IL-6 levels > 50% in comparison with IL-6 at the admission, within 72 hours after the administration
Time Frame
72 hours
Title
D-dimer levels
Description
Reduction of D-dimer levels > 50% in comparison with D-dimer at the admission, within 72 hours after the administration
Time Frame
72 hours
Title
Hospital stay
Description
Length of hospital stay
Time Frame
up to 24 weeks
Title
Duration of positive PCR swab
Description
Time length of negativization of PCR molecular swab
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Cascio, MD, PhD
Phone
3389912198
Email
antonio.cascio03@unipa.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Cascio, MD, PhD
Organizational Affiliation
University of Palermo, Italy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28317735
Citation
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.
Results Reference
background
PubMed Identifier
23851424
Citation
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.
Results Reference
background
PubMed Identifier
32425950
Citation
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.
Results Reference
background
PubMed Identifier
9573019
Citation
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.
Results Reference
background
PubMed Identifier
29241711
Citation
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.
Results Reference
background
PubMed Identifier
28531771
Citation
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.
Results Reference
background
PubMed Identifier
33079850
Citation
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.
Results Reference
background
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Efficacy and Safety of Acetyl L-Carnitine in COVID-19 Patients With Mild-to-Moderate Disease
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