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

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.