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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Use of Acetyl L-Carnitine in Patients With Covid-19 Pneumonia

Conditions
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Covid19

Intervention / Treatment
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* Dietary Supplement: Acetyl L-Carnitine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, open-label, controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetyl L-Carnitine<br>Acetyl L-Carnitine | Dietary Supplement: Acetyl L-Carnitine<br>* Administering 2 gr of Acetyl L-Carnitine orally in addition to the standard of care therapy for 14 days<br>|
| No Intervention: Standard of care<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | Change of hospital mortality | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C reactive protein (CRP) levels | Reduction of CRP levels > 50% in comparison with CRP levels at the admission, within 72 hours after the administration | 72 hours | 
| IL-6 levels | Reduction of IL-6 levels > 50% in comparison with IL-6 at the admission, within 72 hours after the administration | 72 hours | 
| D-dimer levels | Reduction of D-dimer levels > 50% in comparison with D-dimer at the admission, within 72 hours after the administration | 72 hours | 
| Hospital stay | Length of hospital stay | up to 24 weeks | 
| Duration of positive PCR swab | Time length of negativization of PCR molecular swab | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acetyl L-Carnitine