NCT04323514

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2021

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 18, 2020

Last Update Submit

March 24, 2020

Conditions

Keywords

pneumoniacovid-19hospitalized patientsvitamin C

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    Change of hospital mortality

    72 hours

Secondary Outcomes (6)

  • PCR levels

    72 hours

  • Lactate clearance

    72 hours

  • Hospital stay

    72 hours

  • Symptoms

    72 hours

  • Positive swab

    72 hours

  • +1 more secondary outcomes

Study Arms (1)

Patients with COVID-19 pneumonia

EXPERIMENTAL

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

Dietary Supplement: Vitamin C

Interventions

Vitamin CDIETARY_SUPPLEMENT

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

Patients with COVID-19 pneumonia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.R.N.A.S. Civico - Di Cristina - Benfratelli

Palermo, 90127, Italy

RECRUITING

MeSH Terms

Conditions

PneumoniaCOVID-19

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesPneumonia, ViralVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Central Study Contacts

Salvatore Corrao, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2020

First Posted

March 26, 2020

Study Start

March 13, 2020

Primary Completion

March 13, 2021

Study Completion

March 13, 2021

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations