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Interventional study of intravenous vitamin C in definitive patients with covid 19 and its effect on changes in lung CT scan and clinical and laboratory symptoms of patients

Protocol summary

Study aim
Determination of the effect of intravenous vitamin C in patients with definitive covid 19 and its effect on changes in lung CT scan and clinical and laboratory symptoms of patients
Design
Clinical trial with control group, with parallel, bilateral blind, randomized group on 50 patients
Settings and conduct
This study is being performed at Labbafi Nejad Hospital in Tehran on patients with covid 19 pneumonia. Eligible patients enter the study and are divided into two groups after obtaining consent with antibiotic regimen and similar underlying disease. High-dose intravenous vitamin C treatment is given for five days. After five days, the variables will be evaluated and the two groups will be compared.
Participants/Inclusion and exclusion criteria
Patients with covid 19 have been admitted to study conditions. Inclusion criteria: Respiratory Rate> 30, Oxygen Saturation <93%, or lung Infiltration> 50% in lung CT scan Exclusion criteria: Vitamin C allergy, Dyspnea due to cardiac pulmonary edema, Pregnant or breastfeeding women, Chronic kidney disease, Diabetic ketoacidosis, Kidney stones
Intervention groups
This study examines patients with covid 19 who are hospitalized. Patients who are eligible to study are selected first. Then, after obtaining patient consent, treatment with intravenous vitamin C will begin. The dose for this drug supplement is 2 grams every 6 hours and the duration of treatment is 5 days. Attempts are made to treat patients on a similar medication regimen and to have similar variables in terms of age and underlying disease, to minimize the distorting effect of these variables.
Main outcome variables
High doses of intravenous vitamin C affect oxygen oxygenation, respiration rate, pulmonary involvement in CT scan, length of hospital stay, mortality rate, serum CRP level, lymphopenia rate of patients with definitive covid 19.

General information

Reason for update
Acronym
VCACS
IRCT registration information
IRCT registration number: IRCT20200516047468N1
Registration date: 2020-05-19, 1399/02/30
Registration timing: retrospective

Last update: 2020-05-19, 1399/02/30
Update count: 0
Registration date
2020-05-19, 1399/02/30
Registrant information
Name
Hamideh Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 1919
Email address
hamidehmoradi05@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Interventional study of intravenous vitamin C in definitive patients with covid 19 and its effect on changes in lung CT scan and clinical and laboratory symptoms of patients
Public title
Investigation of the effect of intravenous vitamin C on definite patients with coronavirus pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have a positive corona pcr test. Patients over 18 years of age. Oxygen saturation should be below 93%. The patient's respiratory rate should be more than 30 per minute. Lung involvement in chest or CT scans of the lungs is more than 50 percent.
Exclusion criteria:
Allergy to vitamin C The patient's shortness of breath may be due to cardiac pulmonary edema Be pregnant or breastfeeding Have chronic kidney disease Be in diabetic ketoacidosis Have kidney stones
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization is used. Patients eligible to enter the study are randomly selected from a table of numbers and divided into control and intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients with covid 19 who have the conditions to enter the study are first explained about the possible effects of vitamin C on their disease and consent is obtained to start the drug. The intravenous vitamin C is then injected into a group and the placebo is injected into the control group. Laboratory staff and radiologists who report CT scans of patients are unaware of the names of patients in the control group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Third Floor, Faculty of Medicine, Next to Taleghani Hospital, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2020-05-04, 1399/02/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.067

Health conditions studied

1

Description of health condition studied
COVID 19 PNEUMONIA
ICD-10 code
U07.1
ICD-10 code description
This code assigned to a disease diagnosis of COVID-19 confirmed by laboratory testing.

Primary outcomes

1

Description
The amount of lung involvement in a CT scan: According to the radiologist, the appearance of lung involvement and the percentage of lung involvement are measured
Timepoint
Five days after receiving vitamin C intravenously
Method of measurement
According to the radiologist, the appearance of lung involvement and the extent of lung involvement are scoring.

Secondary outcomes

1

Description
Oxygen saturation rate of patients
Timepoint
Five days after receiving vitamin C intravenously
Method of measurement
Using an pulse oxymeter

2

Description
Respiratory rate of patients
Timepoint
Five days after receiving vitamin C intravenously
Method of measurement
Examination by a doctor

3

Description
Serum CRP level
Timepoint
Five days after receiving vitamin C intravenously
Method of measurement
Report by Laboratory

4

Description
lymphopenia rate
Timepoint
Five days after receiving vitamin C intravenously
Method of measurement
Report by Laboratory

5

Description
mortality rate
Timepoint
At the end of the patient's hospitalization
Method of measurement
report by doctor

6

Description
Duration of hospitalization
Timepoint
At the end of the patient's hospitalization
Method of measurement
Calculated by a physician

7

Description
Intubation rate
Timepoint
At the end of the study
Method of measurement
Calculated by the analyzer

Intervention groups

1

Description
Intervention group: In this group of patients, intravenous vitamin C is injected at a dose of 2 grams every 6 hours for five days. The manufacturer of this drug is Iran Daroupakhsh Company. Patients in the intervention group, in addition to intravenous vitamin C, are used diets of meropenem, vancomycin, azithromycin, and Kaletra. Interferon beta injections are also used in some critically ill patients.
Category
Treatment - Drugs

2

Description
Control group: In patients of this group, placebo is injected for five days. Patients in the control group, in addition to placebo, used the medicinal diets of meropenem, vancomycin, azithromycin, and Kaletra. Interferon beta injections are also used in some critically ill patients.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Labbafi Nejad Educational and Medical Hospital
Full name of responsible person
Hamideh Moradi Shahr Babak
Street address
9th Boostan St, Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 23601
Email
hamidehmoradi05@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Deputy of Research and Technology, 5th Floor, Headquarters Building 2, Shahid Beheshti University of Medical Sciences and Health Services, Shahid Abbas Aarabi St, Yemen St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamideh Moradi Shahr Babak
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Unit 3, No. 4, Ebrahimi Alley, Shahid Madani St., Nezam Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1616663914
Phone
+98 34 3411 2418
Email
hamidehmoradi05@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamideh Moradi Shahr Babak
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Unit 3, No. 4, Ebrahimi Alley, Shahid Madani St., Nezam Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1616663914
Phone
+98 34 3411 2418
Email
hamidehmoradi05@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamideh Moradi Shahr Babak
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Unit 3, No. 4, Ebrahimi Alley, Shahid Madani St., Nezam Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1616663914
Phone
+98 34 3411 2418
Email
hamidehmoradi05@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All patient data can be shared after people have not been identified.
When the data will become available and for how long
Start access 3 months after printing the results
To whom data/document is available
Data can be provided to all individuals and institutions.
Under which criteria data/document could be used
Individuals applying for data must have a valid ID card, the purpose of receiving the data must be explained and it must be guaranteed that the data will not be published.
From where data/document is obtainable
To receive data, refer to the office of the Infectious Diseases Department of Labafinejad Hospital in Tehran. Address: Tehran, Pasdaran, 9th Bustan Street
What processes are involved for a request to access data/document
After the applicant comes in person with the required documents, the data will be provided to her after three days.
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