Evaluation of effectiveness of Intravenous vit c in Patients with COVID-19
Design
Two arm parallel group randomized trial with sample size 110 patients. In case group 55 patients treat with intravenous vitamin c and Hydroxychloroquine 400 mg in the first day and then 200 mg BID plus Atazanavir / Ritonavir 300/100 for 5 days. In control group 55 patients treat with Hydroxychloroquine 400 mg in the first day and then 200 mg BID plus Atazanavir / Ritonavir 300/100 for 5 days.Clinical, laboratory and radiologic responses and need to ICU admition evaluate in two groups. The data gathere in questionnaire and then analysis with SPSS version 22.
Settings and conduct
The corona ward in Imam Khomeini Hospital, Theran, Iran.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Definite or probable case of covid-19
At least 18 years old
Exclusion Criteria:
The Patient with chronic renal diseases or ESRD
G6PD deficiency
Intervention groups
Interavenous vitamin c
Main outcome variables
clinical sign and symptoms
Laboratory findings
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200411047025N1
Registration date:2020-04-14, 1399/01/26
Registration timing:prospective
Last update:2020-04-14, 1399/01/26
Update count:0
Registration date
2020-04-14, 1399/01/26
Registrant information
Name
Fereshteh Ghiasvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2811
Email address
ghiasvand_62@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of Intravenous vitamin c in Patients with COVID-19 Referred to Imam Khomeini Hospital: a clinical trial
Public title
Effect of Intravenous vitamin c in Patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old
The case of definite or probable of covid-19
Exclusion criteria:
The patient with chronic renal failure or dialysis
The patient withG6PD deficiency
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is designed to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time. In this study we will be considered 4 patients in a block.
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 Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2020-03-30, 1399/01/11
Ethics committee reference number
IR.TUMS.VCR.REC.1399.078
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
improvement of SPO2 (stands for peripheral capillary oxygen saturation)
Timepoint
Daily, until 3-5 days or discharge
Method of measurement
pulse oximetry
Secondary outcomes
1
Description
fever subside
Timepoint
4 times a day until 3-5 days or discharge
Method of measurement
termometer
2
Description
CRP
Timepoint
Every other day until discharge
Method of measurement
Laboratory test
3
Description
respiratory rate
Timepoint
4 times a day until 3-5 days or discharge
Method of measurement
physical examination
4
Description
lymphocytosis
Timepoint
every other day until discharge
Method of measurement
laboratory test
5
Description
creatinine
Timepoint
every other day until discharge
Method of measurement
Laboratory test
Intervention groups
1
Description
Intervention group: case group 55 patients treat with intravenous vitamin c 1.5 gram 4 times a day and Hydroxychloroquine 400 mg in the first day and then 200 mg BID plus Atazanavir / Ritonavir 300/100 daily 5 days. Every vitamin c vial content of 500 mg and is from Darou Pakhsh factory. The patients receive 3 vials slow infusion (1-2 hours) with normalsaline. Duration of treatment base of clinical response is 3-5 days. Renal function with BUN and CR monitor every other day.
Category
Treatment - Drugs
2
Description
Control group: control group 55 patients treat with Hydroxychloroquine 400 mg in the first day and then 200 mg BID plus Atazanavir / Ritonavir 300/100 daily 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Fereshteh Ghiasvand
Street address
Keshavarz Blvd
City
تهران
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2811
Email
ghiasvand_62@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Saidi
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8163 3618
Email
ghiasvand_62@yahoo.com
Grant name
Grant code / Reference number
47277
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Assistant of 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
Fereshteh Ghiasvand
Position
Assistant Professor of Infectious diseases
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
009861192811
Email
ghiasvand_62@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fereshteh Ghiasvand
Position
Assistant professor of Infectious Diseases
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2811
Email
Ghiasvand_62@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Besharat Zarezade
Position
Resident of infectious diseases
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
009861192811
Email
dr.besharat70@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
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