Investigation of the effect of Finasterid on the prognosis of the hospitalized over 50 years male patients with COVID-19 pneumonia
Design
Phase 3 double-blind randomized controlled clinical trial , on 80 patients.
Randomization method is the use of online software to generate random numbers of KitSet.
Settings and conduct
prescription of finastride in 80 patients with COVID-19 pneumoniain Qazvin"s Bu Ali Sina hospital.
This study will be double- blind and both the patient and the evaluator will be un aware of the type of treatment performed.
Participants/Inclusion and exclusion criteria
males with coronavirus pneumonia over 50 years old
No entry: use of finasterid before covid-19
Intervention groups
In the intervention group, one dose of finastride tablets will be taken daily for 5 days.
In the control group, the placebo will be prescribed for the same period.
Main outcome variables
saturation
diseas s period
mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200505047318N1
Registration date:2020-08-06, 1399/05/16
Registration timing:retrospective
Last update:2020-08-06, 1399/05/16
Update count:0
Registration date
2020-08-06, 1399/05/16
Registrant information
Name
Elham Zarehoseinzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3320 3252
Email address
e.zarehoseinzade@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of "Finasterid" on the prognosis in the hospitalized over 50 years male patients with COVID-19 pneumonia
Public title
Effect of finasterid on COVID-19 treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having covid-19
age>50 years
male
hospitalization
Exclusion criteria:
use finasterid before covid-19
neurologic disease
psychiatric disease
drug users
Age
From 50 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were numbered from 6 to 6.Randomizationmethod was performed using KitSet software (https://kitset.ir/numbers/random) for generating random numbers for A and B and based on the result, they were ranked from 1 to 3,respectivly. Group A recived finasteride and group B recived placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blind and both the patients and the evaluator will be unaware of the type of treatment performed.
Despite the detailed explanation of the study while obtaining the consent of group A or B will not be stated.
The evalutor will not be aware of this.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qavin Universiyy of Medical Sciences
Street address
Booali.Ave
City
Qhazvin
Province
Qazvin
Postal code
3413786313
Approval date
2020-04-21, 1399/02/02
Ethics committee reference number
IR.QUMS.REC.1399.016
Health conditions studied
1
Description of health condition studied
Corona virus pneumonia
ICD-10 code
U07.2
ICD-10 code description
COVID-19,virus not identified
Primary outcomes
1
Description
o2 saturation of blood
Timepoint
initial/fifth day of hospitalization
Method of measurement
pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group :Tab.HCQ 200,Po,Q12h/Amp.Ceftriaxon,1 gr,IV.Q12h/ TTab.finasteride 5mg,PO,Daily,5 days
Category
Treatment - Drugs
2
Description
Control group:Tab.HCQ 200,Po,Q12h/Amp.Ceftriaxon,1 gr,IV.Q12h/ One placebo daily for 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin Bu Ali Sina Hospital
Full name of responsible person
Dr.Abbas Allamy
Street address
Bu Ali.Ave
City
Qazvin
Province
Qazvin
Postal code
3413786313
Phone
+98 28 3333 2931
Email
allami@qums.ac.ir
2
Recruitment center
Name of recruitment center
Bu Ali Sina
Full name of responsible person
Abbas Allamy
Street address
Bu Ali.Ave
City
Qazvin
Province
Qazvin
Postal code
3413786313
Phone
+98 28 3333 2931
Email
allami@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Abbas Allami
Street address
Bu Ali Ave
City
Qazvin
Province
Qazvin
Postal code
3413786313
Phone
+98 28 3333 2931
Email
allami@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Abbas Allami
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Bu Ali Ave.
City
Qazvin
Province
Qazvin
Postal code
3413786313
Phone
+98 28 3333 2930
Email
allami@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Abbas Allami
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Bu Ali Ave.
City
Qazvin
Province
Qazvin
Postal code
3413786313
Phone
+98 28 3333 2930
Email
allami@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Abbas Allami
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Bu Ali Ave.
City
Qazvin
Province
Qazvin
Postal code
3413786313
Phone
+98 28 3333 2930
Email
allami@qums.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
effect of finastride on improving the symptoms of covid-19 pneumonia
When the data will become available and for how long
access begins one year after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
-Research on related issues
From where data/document is obtainable
Qazvin-Bu Ali Ave. Dr.Abbas Allami
allami@qums.ac.ir
What processes are involved for a request to access data/document
it will be provided through coordination via email and presentation of documentation