Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04623619
Enrollment
100
Registered
2020-11-10
Start date
2020-12-15
Completion date
2021-07-31
Last updated
2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

acetyl L-Carnitine

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.

Interventions

DIETARY_SUPPLEMENTAcetyl L-Carnitine

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

Sponsors

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective, randomized, open-label, controlled study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
In-hospital mortality72 hoursChange of hospital mortality

Secondary

MeasureTime frameDescription
C reactive protein (CRP) levels72 hoursReduction of CRP levels \> 50% in comparison with CRP levels at the admission, within 72 hours after the administration
IL-6 levels72 hoursReduction of IL-6 levels \> 50% in comparison with IL-6 at the admission, within 72 hours after the administration
D-dimer levels72 hoursReduction of D-dimer levels \> 50% in comparison with D-dimer at the admission, within 72 hours after the administration
Hospital stayup to 24 weeksLength of hospital stay
Duration of positive PCR swab5 daysTime length of negativization of PCR molecular swab

Contacts

Primary ContactAntonio Cascio, MD, PhD
antonio.cascio03@unipa.it3389912198

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026