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Hospitalized Patients With Covid-19 PneumoniaNCT04323514

Use of Ascorbic Acid in Patients With COVID 19

A study testing Vitamin C in people with Hospitalized Patients With Covid-19 Pneumonia, run by University of Palermo at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Vitamin C
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteItaly
Study dates
13 Mar 2020to 13 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Salvatore Corrao, MD contact

+390916662717

s.corrao@tiscali.it

Italy1 site, 1 recruiting
  • A.R.N.A.S. Civico - Di Cristina - Benfratelli

    Palermo, 90127

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

    Recruiting

Other trials in Italy

About this study

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.

Read the 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.

Being tested
Vitamin C
Keywords
pneumonia, covid-19, hospitalized patients, vitamin C
Medical subject headings
Pneumonia, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin CDietary supplement

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

Study groups in NCT04323514
Study groupRoleWhat they receive
Patients with COVID-19 pneumoniaExperimentalConsecutive patients with COVID-19 pneumonia admitted to ARNAS Civico-Di Cristina-Benfratelli, Palermo
Receives: Dietary Supplement: Vitamin C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital mortality

    Change of hospital mortality

    Measured: 72 hours

Secondary outcomes (6)
  1. PCR levels

    Reduction of PCR levels > 50% in comparison with PCR levels at the admission, within 72 hours after the administration

    Measured: 72 hours

  2. Lactate clearance

    Change of the lactate clearance

    Measured: 72 hours

  3. Hospital stay

    Change of hospital stay days

    Measured: 72 hours

  4. Symptoms

    Resolution of symptoms (Fever, Cough, Shortness of breath or difficulty breathing)

    Measured: 72 hours

  5. Positive swab

    Change of duration of positive swab (nasopharynx and throat)

    Measured: 72 hours

  6. Tomography imaging

    Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2020
  2. Study start13 Mar 2020
  3. Primary completion13 Mar 2021 (estimated)
  4. Study completion13 Mar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04323514
Sponsor's protocol ID
3143
Status last verified
Mar 2020
First submitted
18 Mar 2020
Last updated
26 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin C in people with Hospitalized Patients With Covid-19 Pneumonia, run by University of Palermo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Salvatore Corrao, MD (+390916662717, s.corrao@tiscali.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital mortality (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.

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