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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Antonio Cascio, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Study Description
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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.


Condition or disease Intervention/treatment Phase
Covid19 Dietary Supplement: Acetyl L-Carnitine Not Applicable

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.

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Acetyl L-Carnitine
Acetyl L-Carnitine
 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


Outcome Measures
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Primary Outcome Measures :
  1. In-hospital mortality [ Time Frame: 72 hours ]
    Change of hospital mortality


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Hospital stay [ Time Frame: up to 24 weeks ]
    Length of hospital stay

  5. Duration of positive PCR swab [ Time Frame: 5 days ]
    Time length of negativization of PCR molecular swab


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Antonio Cascio, MD, PhD 3389912198 antonio.cascio03@unipa.it

Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Investigators
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Principal Investigator: Antonio Cascio, MD, PhD University of Palermo, Italy
More Information
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Publications:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Cascio, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo:
acetyl L-Carnitine
Additional relevant MeSH terms:
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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