We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Ascorbic Acid in Patients With COVID 19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323514
Recruitment Status : Unknown
Verified March 2020 by Salvatore Corrao, MD, University of Palermo.
Recruitment status was:  Recruiting
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Salvatore Corrao, MD, University of Palermo

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Hospitalized Patients With Covid-19 Pneumonia Dietary Supplement: Vitamin C Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Ascorbic Acid in Patients With COVID 19
Actual Study Start Date : March 13, 2020
Estimated Primary Completion Date : March 13, 2021
Estimated Study Completion Date : March 13, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Patients with COVID-19 pneumonia
Consecutive patients with COVID-19 pneumonia admitted to ARNAS Civico-Di Cristina-Benfratelli, Palermo
 Dietary Supplement: Vitamin C
10 gr of vitamin C intravenously in addition to conventional therapy.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. In-hospital mortality [ Time Frame: 72 hours ]
    Change of hospital mortality


Secondary Outcome Measures :
  1. 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

  2. Lactate clearance [ Time Frame: 72 hours ]
    Change of the lactate clearance

  3. Hospital stay [ Time Frame: 72 hours ]
    Change of hospital stay days

  4. Symptoms [ Time Frame: 72 hours ]
    Resolution of symptoms (Fever, Cough, Shortness of breath or difficulty breathing)

  5. Positive swab [ Time Frame: 72 hours ]
    Change of duration of positive swab (nasopharynx and throat)

  6. Tomography imaging [ Time Frame: 72 hours ]
    Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323514


Contacts
Layout table for location contacts
Contact: Salvatore Corrao, MD +390916662717 s.corrao@tiscali.it

Locations
Layout table for location information
Italy
A.R.N.A.S. Civico - Di Cristina - Benfratelli Recruiting
Palermo, Italy, 90127
Contact: Salvatore Corrao, MD    +390916662717    s.corrao@tiscali.it   
Sponsors and Collaborators
University of Palermo
  Study Documents (Full-Text)

Documents provided by Salvatore Corrao, MD, University of Palermo:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] March 12, 2020

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Salvatore Corrao, MD, Professor, University of Palermo
ClinicalTrials.gov Identifier: NCT04323514    
Other Study ID Numbers: 3143
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salvatore Corrao, MD, University of Palermo:
pneumonia
covid-19
hospitalized patients
vitamin C
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Pneumonia
Pneumonia, Viral
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases