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Use of Ascorbic Acid in Patients With COVID 19

Primary Purpose

Hospitalized Patients With Covid-19 Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Vitamin C
Sponsored by
University of Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hospitalized Patients With Covid-19 Pneumonia focused on measuring pneumonia, covid-19, hospitalized patients, vitamin C

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • A.R.N.A.S. Civico - Di Cristina - BenfratelliRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with COVID-19 pneumonia

Arm Description

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

Outcomes

Primary Outcome Measures

In-hospital mortality
Change of hospital mortality

Secondary Outcome Measures

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

Full Information

First Posted
March 18, 2020
Last Updated
March 24, 2020
Sponsor
University of Palermo
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1. Study Identification

Unique Protocol Identification Number
NCT04323514
Brief Title
Use of Ascorbic Acid in Patients With COVID 19
Official Title
Use of Ascorbic Acid in Patients With COVID 19
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 13, 2020 (Actual)
Primary Completion Date
March 13, 2021 (Anticipated)
Study Completion Date
March 13, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Palermo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospitalized Patients With Covid-19 Pneumonia
Keywords
pneumonia, covid-19, hospitalized patients, vitamin C

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with COVID-19 pneumonia
Arm Type
Experimental
Arm Description
Consecutive patients with COVID-19 pneumonia admitted to ARNAS Civico-Di Cristina-Benfratelli, Palermo
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Intervention Description
10 gr of vitamin C intravenously in addition to conventional therapy.
Primary Outcome Measure Information:
Title
In-hospital mortality
Description
Change of hospital mortality
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
PCR levels
Description
Reduction of PCR levels > 50% in comparison with PCR levels at the admission, within 72 hours after the administration
Time Frame
72 hours
Title
Lactate clearance
Description
Change of the lactate clearance
Time Frame
72 hours
Title
Hospital stay
Description
Change of hospital stay days
Time Frame
72 hours
Title
Symptoms
Description
Resolution of symptoms (Fever, Cough, Shortness of breath or difficulty breathing)
Time Frame
72 hours
Title
Positive swab
Description
Change of duration of positive swab (nasopharynx and throat)
Time Frame
72 hours
Title
Tomography imaging
Description
Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)
Time Frame
72 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salvatore Corrao, MD
Phone
+390916662717
Email
s.corrao@tiscali.it
Facility Information:
Facility Name
A.R.N.A.S. Civico - Di Cristina - Benfratelli
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatore Corrao, MD
Phone
+390916662717
Email
s.corrao@tiscali.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Ascorbic Acid in Patients With COVID 19

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