Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04623619
Status:
UNKNOWN
Last Update Posted:
2020-11-17
First Post:
2020-11-09
Brief Title:
Efficacy and Safety of Acetyl L-Carnitine in COVID-19 Patients With Mild-to-Moderate Disease
Sponsor:
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Organization:
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Study Overview
Official Title:
Use of Acetyl L-Carnitine in Patients With Covid-19 Pneumonia
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 LCs 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
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 LCs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None