Evaluation of vitamin C efficacy in patients with Cocid-19 and recovery in Abadan medical school
Design
A parallel randomized double blind clinical trial with intervention and placebo group
Settings and conduct
This study will be done in hospitals affiliated to abadan university of medical sciences. 40 Covid-90 patients with inclusion criteria will be assigned to intervention (Vitamin C) and placebo group. The randomization method is block randomization. In this study patients and researchers will be blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients who are diagnosed as Covid-19 patients by positive PCR test or by CT Scan
Exclusion criteria:pregnant and breast feeding patients, patients with kidney stone
Intervention groups
Intervention Group: Patients with Covid-19 that will be Recipient of standard national protocol drugs + Vitamin C 500mg
Control Group: Patients with Covid-19 that will be Recipient of standard national protocol drugs + placebo of Vitamin C
Main outcome variables
Duration of hospital stay, levels of consciousness, respiratory rate, time of separation from ventilator, blood pressure, arterial blood oxygen saturation, condition of gastrointestinal disorders, mortality and morbidity
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20200324046850N5
Registration date:2020-04-04, 1399/01/16
Registration timing:prospective
Last update:2020-04-04, 1399/01/16
Update count:1
Registration date
2020-04-04, 1399/01/16
Registrant information
Name
Sara Mobarak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5326 7800
Email address
s.mobarak@abadanums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-19, 1399/01/31
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Vitamin C on duration of hospital stay in patients with Covid-19
Public title
Study of the effect of vitamin C in patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are diagnosed as Covid-19 patients by positive PCR test or by CT Scan
Exclusion criteria:
pregnant and breast feeding patients, patients with kidney stone
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is block randomization and block size if 4. Randomization sequence and concealment codes will de created by www.sealedenvelope.com website.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo will be produced with a color and taste similar to Vitamin C by Pharmacy school of Jundishapur University.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Abadan faculty of medical sciences
Street address
-
City
Abadan
Province
Khouzestan
Postal code
06313833177
Approval date
2020-03-17, 1398/12/27
Ethics committee reference number
IR.ABADANUMS.REC.1398.119
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19
Primary outcomes
1
Description
Number of hospital days
Timepoint
Daily since hospitalization time
Method of measurement
Based on patient's file
Secondary outcomes
1
Description
fever
Timepoint
Before the start of the intervention - after the end of the intervention, the end of 5 days
Method of measurement
Using oral thermometer
2
Description
Cough
Timepoint
Before the start of the intervention - after the end of the intervention, the end of 5 days
Method of measurement
Clinical observation and examination
3
Description
Chills
Timepoint
Before the start of the intervention - after the end of the intervention, the end of 5 days
Method of measurement
Clinical observation and examination
4
Description
level of consciousness
Timepoint
Before the start of the intervention - after the end of the intervention, the end of 5 days
Method of measurement
Using the Glasgow Coma scale
5
Description
Number of breaths
Timepoint
Before the start of the intervention - after the end of the intervention, the end of 5 days
Method of measurement
Calculate the number of breaths per minute
6
Description
Oxygen saturation of arterial blood
Timepoint
Before the start of the intervention - after the end of the intervention 5 days
Method of measurement
Arterial blood pressure is measured using an pulse oximeter .
7
Description
blood pressure
Timepoint
Before the start of the intervention - after the end of the intervention 5 days
Method of measurement
It is measured using an Sphygmomanometer.
8
Description
Number of deaths
Timepoint
5 days after the end of the intervention
Method of measurement
census report
Intervention groups
1
Description
Control group: Standard Protocol Drugs (Hydroxychloroquine Sulfate Tablet 200mg Two Single Dose Pills or Chloroquine Phosphate 150mg Pill Two Single Dose Pills, Coltra Pills (Lupinavir / Ritonavir)(50/ 200)+A placebo (in terms of appearance and color similar to vitamin C) every 12 hours
Category
Treatment - Drugs
2
Description
Intervention group: Standard Protocol Drugs (Hydroxychloroquine Sulfate Tablet 200mg Two Single Dose Pills (Tehran Drug) or Chloroquine Phosphate 150mg Pill Two Single Dose Pills (Pars), Coltra Pills (Lupinavir / Ritonavir)) 200) + Vitamin C 500mg every 12 hours for 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Abadan Taleghani Hospital
Full name of responsible person
سارا مبارک
Street address
-
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Email
s.mobarak@abadanums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Street address
-
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Email
s.mobarak@abadanums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadan 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
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
-
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Fax
Email
S.mobarak@abadanums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
-
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Fax
Email
S.mobarak@abadanums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
-
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Fax
Email
S.mobarak@abadanums.ac.ir
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