Study the effect of corticosteroid on the outpatient treatment Covid-19 patients
Design
70 outpatient patients with covid-19 will be randomly assigned to intervention and control (placebo) groups. Randomization will be done by simple randomization via www.randomization.com. This is a phase 3 trial with parallel groups and triple blinded.
Settings and conduct
This study will be held in 3 outpatient center. Blinding will be triple blind, so that neither patient, physician, the outcome assessor and data analyzer are not aware of the groups. patients in intervention and placebo groups will be treated for 5 days and followed for 1 month.
Participants/Inclusion and exclusion criteria
Inclusion criteria: definite case of Covid-19, age over 18, presented in day 5th-10th from the start of sign and symptoms; Exclusion criteria: severe cases with SpO2 under 90, using an antiviral in previous two weeks, previous infection with covid-19, using an steroid in previous two weeks, being under treatment with steroid, previous allergic to ُSteroid, pregnancy, lactating, immunosupressive state
Intervention groups
Intervention: Prednisolone 50 milligram, once daily for 5 days; Control: Placebo, 1 pill per day for 5 days
Main outcome variables
Treatment failure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171219037964N2
Registration date:2020-12-02, 1399/09/12
Registration timing:prospective
Last update:2020-12-02, 1399/09/12
Update count:0
Registration date
2020-12-02, 1399/09/12
Registrant information
Name
Babak Amra
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
amra@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of Steroid on the outpatient treatment Covid-19 patients
Public title
The effect of Steroid on the outpatient treatment of Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
definite case of Covid-19
age over 18
presented in day 5th-10th from the start of sign and symptoms
Exclusion criteria:
Severe cases with SpO2 under 90
Using an antiviral in previous two weeks
Previous infection with covid-19
Using an steroid in previous two weeks
Being under treatment with steroid
Previous allergic to Steroid
Pregnancy
Lactating
Immunosupressive state
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using simple randomization. A random string will be made using www.randomization.com for 70 number in two groups. each patient will be assigned with a number by the physician. then this number will be matched by the random string by research assistant and the patient will be assigned to group A or B according to that.
Blinding (investigator's opinion)
Triple blinded
Blinding description
patients will be assigned to groups Intervention (prednisolone) or Control (placebo). placebo is designed just the same as Prednisolone and in a same pack. packages is defined by A or B and neither of patient, physician, researchers, outcome assessor and data analyzer do not know the meaning of codes. Just the research assistant is aware of codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezarjerib st.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-12-01, 1399/09/11
Ethics committee reference number
IR.MUI.MED.REC.1399.781
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
Treatment failure
Timepoint
days 3, 7, 14, 21, 28 from the start of treatment
Method of measurement
interview with patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients in this group will be treated by Prednisolone 50 milligram, once daily for 5 days
Category
Treatment - Drugs
2
Description
Control group: patients in this group receive placebo, 1 pill daily for 5 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Amra clinic
Full name of responsible person
Dr. Babak Amra
Street address
Sepahsalar St.
City
Isfahan
Province
Isfehan
Postal code
8166863543
Phone
+98 31 3776 6293
Email
amrababak@gmail.com
2
Recruitment center
Name of recruitment center
Dr. soltaninejad clinic
Full name of responsible person
Dr. Forough Soltaninejad
Street address
No. 409, Noor building, Shamsabadi St.
City
Isfahan
Province
Isfehan
Postal code
8134654669
Phone
+98 31 3234 0059
Email
f.soltaninejad@med.mui.ac.ir
3
Recruitment center
Name of recruitment center
Dr. Salahi clinic
Full name of responsible person
Dr. Mehrdad Salahi
Street address
First floor, Iranian Clinic, Ferdosi St.
City
Shahinshahr
Province
Isfehan
Postal code
8314896713
Phone
+98 31 4527 0780
Email
salahimehrdad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezarjerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Babak Amra
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Respiratory disease
Street address
Isfahan University of Medical Sciences, Hezarjerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
Email
Amra@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Amra
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Respiratory disease
Street address
Isfahan University of Medical Sciences, Hezarjerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
Email
Amra@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Amra
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Respiratory disease
Street address
Isfahan University of Medical Sciences, Hezarjerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
Email
Amra@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after being unidentified
When the data will become available and for how long
one month after the publication of results
To whom data/document is available
All researches are allowed to apply for the data
Under which criteria data/document could be used
For using in systematic review analysis
From where data/document is obtainable
email to amrababak@gmail.com
What processes are involved for a request to access data/document
The application email will be sent to the chancellor for research of Isfahan University of Medical Sciences, after the approval the data will be sent to the applicant