Protocol summary

Study aim
Determining and comparing the therapeutic effects of intravenous vitamin C injection on laboratory findings in covid-19 patients
Design
A clinical trial with a control placebo group; parallel groups; single-blind; phase 3; performed on 90 patients; using Random Allocation Software.
Settings and conduct
The study is a one-sided blind clinical intervention .Initially, 90 patients with covid-19 who were admitted to Taleghani hospital wards were divided into two groups of 45 receiving standard treatment with intravenous vitamin C (intervention group) and receiving only standard treatment (control group).The intervention includes injection of vitamin C in amount of 1.5 gr for each patient in the intervention group by intravenous infusion ,using normal saline 500 cc in 4 hours, at the moment of entering the ward. Both study groups will receive all standard procedures and treatment, equally, but do not know which placebo to inject and which drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adults (age 18 years or older); SPO2<92%; Being treated in the ward; Positive PCR test; Involvement of Chest-CT-Scan. Exclusion criteria: Patients with a history of allergy to vitamin C; Patients with dyspnea caused by cardiogenic pulmonary edema; Pregnant and Lactating women; Patients with a previous history of end-stage pulmonary disease, end-stage malignant tumor, diabetic ketoacidosis, severe kidney disease; Active kidney stone disease
Intervention groups
The intervention includes injection of vitamin C in amount of 1.5 gr for each patient in the intervention group by intravenous infusion ,using normal saline 500 cc in 4 hours, at the moment of entering the ward and for control group ,a placebo with the above specification is injected.
Main outcome variables
WBC ,CRP ,ESR , AST ,ALT ,ALK.P, PT ,PTT ,INR ,LDH ,Ferritin , D-dimer , duration of hospitalization ,death

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220228054146N1
Registration date: 2022-03-02, 1400/12/11
Registration timing: retrospective

Last update: 2022-03-02, 1400/12/11
Update count: 0
Registration date
2022-03-02, 1400/12/11
Registrant information
Name
Reza Malek
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3224 8760
Email address
drreza881370@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
2021-03-21, 1400/01/01
Actual recruitment end date
2021-09-22, 1400/06/31
Trial completion date
2021-09-22, 1400/06/31
Scientific title
Assessment of intravenous of vitamin C therapeutic effects on laboratory findings in covid-19 patients
Public title
Effects of vitamin C on covid-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults (age 18 years or older) SPO2<92% Being treated in the ward Positive PCR test Involvement of Chest-CT-Scan
Exclusion criteria:
Patients with a history of allergy to vitamin C Patients with dyspnea caused by cardiogenic pulmonary edema Pregnant women Lactating women Patients with a previous history of end-stage pulmonary disease, end-stage malignant tumor, diabetic ketoacidosis, severe kidney Active kidney stone disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups of vitamin C treatment (intervention group) and the control group using Block Randomization Method. Initially, 6 blocks are prepared with the AAABBB combination and all possible modes of this combination are listed. A specific code is then assigned to each combination. Then, according to the sample size and the volume of the blocks, 14 blocks are selected ,using randomization method .All this process is done, using Random Allocation Software under the supervision of an epidemiologist.
Blinding (investigator's opinion)
Single blinded
Blinding description
All participants in this study are divided into two groups, receiving vitamin C (intervention group) and the control group, but expect for health staff, no patient knows that the placebo was injected or vitamin C. So only patients in this study are blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Resalet Blvd ,Urganse Alley, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2021-03-10, 1399/12/20
Ethics committee reference number
IR.UMSU.REC.1400.009

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19; virus identified

Primary outcomes

1

Description
White Blood Cell including neutrophil and lymphocyte
Timepoint
Before the intervention and 5 days after
Method of measurement
Measure with blood test and scale with X1000/mm3

2

Description
Inflammatory factor(Erythrocyte Sedimentation Rate)/ESR
Timepoint
Before the intervention and 5 days after
Method of measurement
Measure with blood test and scale with mm/h

3

Description
Inflammatory factor (C-Reactive Protein)/CRP
Timepoint
Before the intervention and 5 days after
Method of measurement
Measure with blood test and scale with Diagnostic Kit Unite /liter

4

Description
Alkaline Phosphatase(Enzyme in liver and bones)/ALK-P
Timepoint
Before the intervention and 5 days after
Method of measurement
Measure with blood test and scale with Diagnostic Kit Unite /liter

5

Description
Aspartate aminotransferase(Liver enzyme)/AST
Timepoint
Before the intervention and 5 days after
Method of measurement
Measure with blood test and scale with Diagnostic Kit Unite /liter

6

Description
Alanine aminotransferase(Liver enzyme)/ALT
Timepoint
Before the intervention and 5 days after
Method of measurement
Measure with blood test and scale with Diagnostic Kit Unite /liter

7

Description
Lactate dehydrogenase(Enzyme in heart and Red blood cell)/LDH
Timepoint
Before the intervention and 5 days after
Method of measurement
Measure with blood test and scale with Diagnostic Kit Unite /liter

8

Description
Blood coagulation factor(D-dimer)
Timepoint
Before the intervention and 5 days after
Method of measurement
Measure with blood test and scale with Diagnostic Kit Unite /liter

9

Description
Blood coagulation factor(Prothrombin Time)/PT
Timepoint
Before the intervention and 5 days after
Method of measurement
Measure with blood test and scale with Diagnostic Kit Unite /liter

10

Description
Blood coagulation factor(Partial Thromboplastin Time)/PTT
Timepoint
Before the intervention and 5 days after
Method of measurement
Measure with blood test and scale with Diagnostic Kit Unite /liter

11

Description
Blood coagulation factor(International Normalized Ratio)/INR
Timepoint
Before the intervention and 5 days after
Method of measurement
Measure with blood test and scale with Diagnostic Kit Unite /liter

12

Description
Inflammatory factor(Ferritin)
Timepoint
Before the intervention and 5 days after
Method of measurement
Measure with blood test and scale with Diagnostic Kit Unite /liter

Secondary outcomes

1

Description
Duration of hospitalization
Timepoint
Day of arrival until discharge from the hospital
Method of measurement
Patient record

2

Description
Death
Timepoint
Day of arrival until discharge from the hospital or death
Method of measurement
Patient record

Intervention groups

1

Description
Intervention group: Injection of vitamin C (Caspian Company) in amount of 1.5 gr for each patient in the intervention group is performed as an intravenous infusion using normal saline serum(500 cc) in 4 hours ,at the moment of entering the ward.
Category
Treatment - Drugs

2

Description
Control group: Injection of placebo in amount of 1.5 gr for each patient in the control group is performed as an intravenous infusion using normal saline serum(500 cc) in 4 hours ,at the moment of entering the ward.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr.Rahim Nejadrahim
Street address
Kashani street , Taleghani hospital
City
Urmia
Province
West Azarbaijan
Postal code
5713613481
Phone
+98 914 141 1057
Email
Nejadrahim@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Golizadeh
Street address
Resalet Blvd ,Urganse Alley, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 1930
Fax
+98 44 3224 0642
Email
GolizadeSaber12@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Reza Malek
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reza Malek
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pathology
Street address
Jahad Blvd, Rahnamayi Blvd, Modiriat street, Emdad Alley, Gavam Apartment, First Floo
City
Urmia
Province
West Azarbaijan
Postal code
5713613481
Phone
+98 44 3224 8760
Email
drreza881370@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reza Malek
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pathology
Street address
Jahad Blvd, Rahnamayi Blvd, Modiriat street, Emdad Alley, Gavam Apartment, First Floo
City
Urmia
Province
West Azarbaijan
Postal code
5713613481
Phone
+98 44 3224 8760
Email
Drreza881370@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reza Malek
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pathology
Street address
Jahad Blvd, Rahnamayi Blvd, Modiriat street, Emdad Alley, Gavam Apartment, First floo
City
Urmia
Province
West Azarbaijan
Postal code
5713613481
Phone
+98 44 3224 8760
Email
drreza881370@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...