Protocol summary
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Study aim
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We aimed to assess the effect of high dose vitamin C on clinical improvement and inflammatory indices in moderate to severe COVID-19 patients.
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Design
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Randomized double blind clinical trial on two arms containing control and treatment group
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Time to clinical improvement (TTIC), change in Sequential Organ Failure Assessment (SOFA) score, National Early Warning Score (NEWS) 2, Ordinal scale for clinical improvement, Length of hospital stays, inflammatory indices, and mortality
General information
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Reason for update
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Revision of inclusion and exclusion criteria and outcomes
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190917044805N2
Registration date:
2020-03-31, 1399/01/12
Registration timing:
prospective
Last update:
2021-07-10, 1400/04/19
Update count:
1
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Registration date
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2020-03-31, 1399/01/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-03, 1399/01/15
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Expected recruitment end date
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2020-10-06, 1399/07/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of High-dose Vitamin C on Treatment, Clinical Symptoms and Laboratory Signs of Iranian COVID-19 Patients: A Double Blind Randomized Clinical Trial
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Public title
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Effects of High-dose Vitamin C on COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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 respiratory rate > 30 breaths/min; or severe respiratory distress; or SpO2 < 90% 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)
Patients with past medical history of kidney stone
Pregnancy or breastfeeding
Documented diagnosis of cancer
History of G6PD deficiency and interstitial lung disease
More than 1 gram/day intake of vitamin C supplement in last 7 days
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Age
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From 18 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The method of randomization is based on block randomization using random 4 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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-27, 1399/01/08
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Ethics committee reference number
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IR.TUMS.VCR.REC.1399.056
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19 confirmed by laboratory testing
Primary outcomes
1
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Description
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Time to clinical improvement (TTIC)
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Timepoint
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day 0, 5, at discharge
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Method of measurement
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assessing respiratory rate, blood oxygen saturation, fever
2
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Description
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Change in Sequential Organ Failure Assessment (SOFA) score
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Timepoint
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day 0, 3, and 5
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Method of measurement
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SOFA scoring system
Secondary outcomes
1
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Description
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National Early Warning Score (NEWS) 2
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Timepoint
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On day 0, 3, and 5
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Method of measurement
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NEWS 2 scoring system
2
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Description
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Ordinal scale for clinical improvement
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Timepoint
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On day 0, 3, and 5
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Method of measurement
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WHO scoring system
3
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Description
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Hospital Length of Stay
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Timepoint
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Days after receiving infusion
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Method of measurement
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days
4
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Description
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The change of inflammatory markers
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Timepoint
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On day 0, 3, and 5
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Method of measurement
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C-reactive protein, Neutrophil-lymphocyte ratio, Ferritin
5
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Description
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Mortality
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Timepoint
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During 30 days of receiving infusion
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Method of measurement
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Number of subjects
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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data for primary outcomes can be available after requesting scientific responsible person.
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When the data will become available and for how long
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starting 6 months after publication
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To whom data/document is available
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this only available for people working in academic institutions
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Under which criteria data/document could be used
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there is no limitation
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From where data/document is obtainable
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documents are available by scientific responsible person by email kourosh.sadeghi@gmail.com
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What processes are involved for a request to access data/document
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documents are available after assessing the aim and identity of requesting person
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Comments
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