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.
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
- Conditions the study is for
- Hospitalized Patients With Covid-19 Pneumonia
- 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.
Italy1 site, 1 recruiting
- Recruiting
A.R.N.A.S. Civico - Di Cristina - Benfratelli
Palermo, 90127
Salvatore Corrao, MD, +390916662717, s.corrao@tiscali.it
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 group | Role | What they receive |
|---|---|---|
| Patients with COVID-19 pneumonia | Experimental | Consecutive 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.
In-hospital mortality
Change of hospital mortality
Measured: 72 hours
Secondary outcomes (6)
PCR levels
Reduction of PCR levels > 50% in comparison with PCR levels at the admission, within 72 hours after the administration
Measured: 72 hours
Lactate clearance
Change of the lactate clearance
Measured: 72 hours
Hospital stay
Change of hospital stay days
Measured: 72 hours
Symptoms
Resolution of symptoms (Fever, Cough, Shortness of breath or difficulty breathing)
Measured: 72 hours
Positive swab
Change of duration of positive swab (nasopharynx and throat)
Measured: 72 hours
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.
- First posted26 Mar 2020
- Study start13 Mar 2020
- Primary completion13 Mar 2021 (estimated)
- Study completion13 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized Patients With Covid-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Corrao, MD, University of Palermo
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ascorbic Acid in Patients With COVID 19
- ClinicalTrials.gov ID
- NCT04323514
- Acronym / sponsor ID
- 3143
- Keywords
- pneumonia, covid-19, hospitalized patients, vitamin C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 13 Mar 2021 (estimated)
- Study completion
- 13 Mar 2021 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with COVID-19 pneumonia | Experimental | Dietary Supplement: Vitamin CConsecutive patients with COVID-19 pneumonia admitted to ARNAS Civico-Di Cristina-Benfratelli, Palermo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- In case of doubt of interstitial pneumonia with indications for intubation
- Positive swab test of SARS-CoV-2
- Interstitial pneumonia
- Signature of informed consent
Key exclusion criteria (2 listed)
- Unsigned informed consent
- Negative swab test of SARS-CoV-2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C10 gr of vitamin C intravenously in addition to conventional therapy. | Dietary supplement | Patients with COVID-19 pneumonia |
Primary outcome
In-hospital mortality
Time frame: 72 hours
Change of hospital mortality
6 secondary outcomes
PCR levels
Time frame: 72 hours
Lactate clearance
Time frame: 72 hours
Hospital stay
Time frame: 72 hours
Symptoms
Time frame: 72 hours
Positive swab
Time frame: 72 hours
Tomography imaging
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.