Use of Ascorbic Acid in Patients With COVID 19

• ClinicalTrials.gov Identifier: NCT04323514
• Recruitment Status: Recruiting
• First Posted: March 26, 2020
• Last Update Posted: March 26, 2020
• Sponsor: University of Palermo
• Information provided by (Responsible Party): Salvatore Corrao, MD, University of Palermo

Tracking Information

• First Submitted Date: March 18, 2020
• First Posted Date: March 26, 2020
• Last Update Posted Date: March 26, 2020
• Actual Study Start Date: March 13, 2020
• Estimated Primary Completion Date: March 13, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 24, 2020)

In-hospital mortality [ Time Frame: 72 hours ]

Change of hospital mortality

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 24, 2020)

• PCR levels [ Time Frame: 72 hours ]
  Reduction of PCR levels > 50% in comparison with PCR levels at the admission, within 72 hours after the administration
• Lactate clearance [ Time Frame: 72 hours ]
  Change of the lactate clearance
• Hospital stay [ Time Frame: 72 hours ]
  Change of hospital stay days
• Symptoms [ Time Frame: 72 hours ]
  Resolution of symptoms (Fever, Cough, Shortness of breath or difficulty breathing)
• Positive swab [ Time Frame: 72 hours ]
  Change of duration of positive swab (nasopharynx and throat)
• Tomography imaging [ Time Frame: 72 hours ]
  Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of Ascorbic Acid in Patients With COVID 19
• Official Title: Use of Ascorbic Acid in Patients With COVID 19

Brief Summary

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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hospitalized Patients With Covid-19 Pneumonia

Intervention

Dietary Supplement: Vitamin C

10 gr of vitamin C intravenously in addition to conventional therapy.

Study Arms

Experimental: Patients with COVID-19 pneumonia

Consecutive patients with COVID-19 pneumonia admitted to ARNAS Civico-Di Cristina-Benfratelli, Palermo

Intervention: Dietary Supplement: Vitamin C

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 24, 2020): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 13, 2021
• Estimated Primary Completion Date: March 13, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• In case of doubt of interstitial pneumonia with indications for intubation
• Positive swab test of SARS-CoV-2
• Interstitial pneumonia
• Signature of informed consent

Exclusion Criteria:

• Unsigned informed consent
• Negative swab test of SARS-CoV-2

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

Contact: Salvatore Corrao, MD; +390916662717; s.corrao@tiscali.it

• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT04323514
• Other Study ID Numbers: 3143
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Salvatore Corrao, MD, University of Palermo
• Study Sponsor: University of Palermo
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Palermo
• Verification Date: March 2020