Effects of High-dose Vitamin C on Treatment, Clinical Symptoms and Laboratory Signs of Iranian COVID-19 Patients: A Double Blind Randomized Clinical Trial
We aimed to assess the effect of high dose vitamin C on clinical improvement and inflammatory indices in moderate to severe COVID-19 patients.
Design
Randomized double blind clinical trial on two arms containing control and treatment group
Settings and conduct
After selecting eligible patients in Dr. Shariati teaching hospital, pharmacist will allocate each patient to one study group by table of randomization and prepare the serum content. investigator, physician and healthcare provider are blinded. biochemical tests, inflammatory indices and respiratory support will be assessed based on defined schedule. At the end of the study results will be presented to analyzer in two blinded groups.
Participants/Inclusion and exclusion criteria
Confirmed moderate to severe COVID-19, age more than 18 years and consent for participation in the study, negative history for nephrolithiasis, chronic kidney disease (stage 4) and hemodialysis, pregnancy and breastfeeding will included in this study.
Intervention groups
Treatment group will receive 12g Vitamin C in dextrose5% to total volume of 200 ml for 4 days and placebo group will receive distilled water in dextrose5% to total volume of 200 ml for 4 days.
Main outcome variables
in hospital mortality; length of hospital stay; need to ICU admission; need to intubation; need to respiratory support; inflammatory indices; organs function specially pulmonary function; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190917044805N2
Registration date:2020-03-31, 1399/01/12
Registration timing:prospective
Last update:2020-03-31, 1399/01/12
Update count:1
Registration date
2020-03-31, 1399/01/12
Registrant information
Name
Kourosh Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
sadeghi_k@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-10-06, 1399/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of High-dose Vitamin C on Treatment, Clinical Symptoms and Laboratory Signs of Iranian COVID-19 Patients: A Double Blind Randomized Clinical Trial
Public title
Effects of High-dose Vitamin C on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Older than 18 years old
admission with moderate to severe COVID-19 based on WHO definition
Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or Clinical assessment AND SpO2 ≤ 94% on room air,
Willing and be able to provide written informed consent prior to performing study procedures
Exclusion criteria:
Participation in any other clinical trial of an experimental treatment for COVID-19
Critical ill patients that need invasive mechanical ventilation
Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
Patents with past medical history of kidney stone
Pregnancy or breastfeeding
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is based on block randomization using random 4, 6 and 8 blocks.Table of patients number and block Randomization codes will be created by Online randomization web page and will be presented to pharmacist in-charged for serum content preparation. investigator informs patient inclusion number and serum ingredient will be determined by pharmacist based on randomization table.
Blinding (investigator's opinion)
Double blinded
Blinding description
this study will be conducted as a double blind process. patients, investigator, health care workers including nurses and physicians, statistical analyzer will be blinded, by preparing serum content by pharmacist and allocating a code to each serum. pharmacist is the only one who knows the content and has no role in data gathering and result interpretation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor In Research Affairs- Tehran University of Medical Science
Street address
Vice Chancellor for Research and Technology, Sixth Floor, Qods Ave., Keshavarz Blvd.
Intervention group: this group adjunct to standard treatment will receive intravenous infusion of 12 grams of vitamin C in Dextrose 5% serum to the total volume of 200 ml over 24 hours for 4 days
Category
Treatment - Drugs
2
Description
Control group: infusion of serum containing 120 ml distilled water in Dextrose 5% serum to the total volume of 200 ml over 24 hours for 4 days beside receiving standard treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati hospital
Full name of responsible person
Kourosh Sadeghi
Street address
Dr Shariati Educational and Research Center, Jalal Al Ahmad Road, North Kargar Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
kourosh.sadeghi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
kurosh sadeghi
Street address
16th azar street
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 8490 1000
Email
sadeghi_k@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Kourosh Sadeghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 226, Qods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8889 6696
Email
kourosh.sadeghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kourosh Sadeghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school, Tehran university of medical sciences, 16 Azar street
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 6695 4709
Fax
Email
Sadeghi_k@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kourosh Sadeghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
16th Azar street
City
Tehran
Province
Tehran
Postal code
14176114411
Phone
+98 21 8490 1000
Email
sadeghi_k@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
data for primary outcomes can be available after requesting scientific responsible person.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
this only available for people working in academic institutions
Under which criteria data/document could be used
there is no limitation
From where data/document is obtainable
documents are available by scientific responsible person by email kourosh.sadeghi@gmail.com
What processes are involved for a request to access data/document
documents are available after assessing the aim and identity of requesting person