The aim of this study was to evaluate the effect of high dose intravenous vitamin C in COVID-19 patients admitted to the intensive care unit.
Design
Clinical trial with control group, with parallel, non-blind, randomized, phase 2 groups on 200 patients. Excel software rand function will be used for randomization.
Settings and conduct
Patients are randomly divided into intervention and control groups according to the treatment protocol of the Ministry of Health and in the intervention group, despite treatment with standard protocol, vitamin C is also prescribed.This treatment will be every 12 hours and 4 grams per day.
Participants/Inclusion and exclusion criteria
Inclusion criteria: adults (18 years and older); respiratory failure index (RIF) (arterial oxygen stress (or pressure)/ fraction-inspired oxygen) <300 mm Hg; treated in ICU.
Exclusion criteria: patients with a history of vitamin C allergy; patients with asthma due to cardiopulmonary edema; pregnant or lactating women; patients whose survival time is less than 24 hours; patients with a previous history of end-stage lung disease, end-stage malignant tumor, G-6-PD deficiency, diabetic ketoacidosis, active kidney stone disease, and severe kidney disease; patients who have already enrolled in another clinical trial; patients with a known history of kidney disease, chronic renal failure, or acute renal failure during hospitalization will be excluded from the study.
Intervention groups
Intervention group: COVID-19 patients will receive standard drugs of the national protocol and vitamin C by injection.
The control group includes patients who receive standard drugs of the national protocol and vitamin C placebo.
Main outcome variables
Oxygen saturation; respiration rate; length of hospital stay; mortality rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210714051891N1
Registration date:2021-09-29, 1400/07/07
Registration timing:prospective
Last update:2021-09-29, 1400/07/07
Update count:0
Registration date
2021-09-29, 1400/07/07
Registrant information
Name
Moloud Balafar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 2078
Email address
balafarm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-07, 1400/07/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of high-dose vitamin C in the treatment of patients with COVID-19 admitted to the critical care ward
Public title
The effect of vitamin C in the treatment of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Respiratory failure index (RIF)
Treated in the ICU
Exclusion criteria:
Patients with a history of vitamin C allergy.
Patients with asthma due to cardiopulmonary edema
Pregnant or lactating women
Patients with a survival time of less than 24 hours
Patients with a history of end-stage lung disease, end-stage malignant tumor, G-6-PD deficiency, diabetic ketoacidosis, active kidney stone disease, and severe kidney disease
Patients who have already enrolled in another clinical trial
Patients with a known history of kidney disease, chronic renal failure, or acute renal failure during hospitalization
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization; randomization unit: individual; randomization tool: using EXCEL software in two groups randomly
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Vice-Chancellor, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-08-30, 1400/06/08
Ethics committee reference number
IR.TBZMED.REC.1400.519
Health conditions studied
1
Description of health condition studied
COVID-19 patients
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
The amount of lung involvement in a CT scan
Timepoint
Every 12 hours, Up to 10 days
Method of measurement
According to the radiologist, the appearance of lung involvement and the percentage of lung involvement are measured.
Secondary outcomes
1
Description
Oxygen saturation
Timepoint
Every 12 hours, Up to 10 days
Method of measurement
Observations and clinical examinations
2
Description
Respiratory rate
Timepoint
Every 12 hours, Up to 10 days
Method of measurement
Observations and clinical examinations
3
Description
Duration of hospitalization
Timepoint
Daily since hospitalization time
Method of measurement
Based on patient records
4
Description
Mortality rate
Timepoint
Daily
Method of measurement
Census
Intervention groups
1
Description
Intervention group: Vitamin C is made by Osweh Pharmaceutical Company, will be administered 4 grams by injection every 12 hours for 10 days.
Category
Treatment - Drugs
2
Description
Control group: They will not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Moloud Balafar
Street address
Imam Reza Hospital- Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 2078
Email
m.balafar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
samieim@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Moloud Balafar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Reza Hospital- Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 2078
Email
m.balafar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Moloud Balafar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Reza Hospital- Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 2078
Email
m.balafar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Moloud Balafar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Reza Hospital- Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 2078
Email
m.balafar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available