Hospitalized Patients With Covid-19 Pneumonia Clinical Trial
Official title:
Use of Ascorbic Acid in Patients With COVID 19
Different studies showed that ascorbic acid (vitaminC) positively affects the development and
maturation of T-lymphocytes, in particular NK (natural Killer) cells 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 systemic inflammatory syndrome.
Recent studies have also demonstrated the effectiveness of vitamin C administration in terms
of reducing mortality, in patients with sepsis hospitalized in intensive care wards.
Given this background, in the light of the current COVID-19 emergency, since the
investigators cannot carry out a randomized controlled trial, it is their intention to
conduct a study in the cohort of hospitalized patients with covid-19 pneumonia, administering
10 gr of vitamin C intravenously in addition to conventional therapy.
The Sars-COV-2, has spread all over the world, in two months after its discovery in China.
Outbreaks have been reported in more than 50 countries with more than 118,223 confirmed cases
and 4,291 deaths worldwide. In Italy, the scenario is progressively worsening with 8514
confirmed cases and 631 deaths at 10/3/2020.
Along with the spread of this new virus there has been an increase in the number of pneumonia
identified with the term novel coronavirus (2019-nCoV)-infected pneumonia (NCIP), which are
characterized by fever, asthenia, dry cough, lymphopenia, prolonged prothrombin time,
elevated lactic dehydrogenase, and a tomographic imaging indicative of interstitial pneumonia
(ground glass and patchy shadows).
Recent studies have shown the efficacy of vitamin C and thiamine administration in patients
hospitalized for sepsis in the setting of intensive wards in terms of mortality reduction.
The use of intravenously vitamin C arises from the experimental evidence of its
anti-inflammatory and antioxidant properties. Vitamin C causes a greater proliferation of
natural killers without affecting their functionality. Moreover, the vitamin C reduces the
production of ROS (reactive oxygen species) that contribute to the activation of the
inflammosomi and, in particular, the NLRP3 that affetcs the maturation and secretion of
cytokines such as IL1beta and IL-18 that are involved in the inflammatory systemic syndrome
that characterized sepsis. Vitamin C blocks the expression of ICAM-1 and activation of
NFKappaB that are involved in inflammatory, neoplastic, and apoptotic processes by the
inhibition of TNFalfa.
For this reason, the use of vitamin C could be effective in terms of mortality and secondary
outcomes in the cohort of patients with covid-19 pneumonia.
In view of the emergency of SARS-VOC-2 and the impossibility of carrying out a randomized
controlled study, it is their intention to conduct an intervention protocol (administration
of 10 grams of vitamin C intravenously in addition to conventional therapy) involving the
cohort of hospitalized patients with covid-19 pneumonia.
Methods:
An uncontrolled longitudinal study will be conducted at the Arnas Civico-di
Cristina-Benfratelli National Relevance Hospital in Palermo. This study will include all
patients consecutively hospitalized with positive swab test of SARS-CoV-2 and interstitial
pneumonia or with interstitial pneumonia with indication of intubation. At the admission,
data will be collected: personal and anamnestic information, clinical and laboratory findings
such as Gender, Age, Ethnicity, Comorbidities, Drugs, blood urea nitrogen, Creatinine,
Electrolytes, Blood cell count, Clearance of the lactates, PCR, PCT, SOFA score, liver
function, Coagulation, Blood gas analysis, Systolic and Diastolic Blood Pressure, Sp02,
Glycaemia, Body Mass Index (BMI). Length of hospital stay will be recorded. After written
informed consent, 10 grams of vitamin C in 250 ml of saline to infuse at a rate of 60 drops /
minute will be administered. In-hospital mortality, reduction of PCR levels > 50% in
comparison with PCR levels at the admission within 72 hours after the administration, lactate
clearance, length of hospital stay, resolution of symptoms, duration of positive swab (days).
Resolution of the CT imaging will be analysed. Stata Statistical Software: Release 14.1.
College Station, TX: StataCorp LP) was used for database management and analysis.
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