Comparison of blood oxygen saturation percentage in two groups of interferon received covid patients and control patients
Comparison of length of hospitalization between intervention and control groups
Comparison of ICU hospitalization rate in two intervention and control groups
Comparison of 28-day mortality rate of two intervention and control groups
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. The rand function of Excel software was used for randomization
Settings and conduct
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. The rand function of Excel software was used for randomization
Participants/Inclusion and exclusion criteria
Patients with Crona pneumonia needed to be hospitalized
Intervention groups
Patients who received interferon in addition to common corona treatment
Main outcome variables
Hospitalization period
Death rate
Effect on blood oxygen
Effect on the need for ICU Care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230930059562N1
Registration date:2023-10-06, 1402/07/14
Registration timing:retrospective
Last update:2023-10-06, 1402/07/14
Update count:0
Registration date
2023-10-06, 1402/07/14
Registrant information
Name
Roya Rahmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 465 5334
Email address
roya.rahmani89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-21, 1399/11/02
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
2021-01-21, 1399/11/02
Actual recruitment end date
2021-07-22, 1400/04/31
Trial completion date
2021-09-22, 1400/06/31
Scientific title
Effect of interfron in the treatment of covid
Public title
Effect of interfron in the treatment of covid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Covid pneumonia who needs to hospitalised
Exclusion criteria:
Oxygen saturation percentage above 89%
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method using a table of random numbers
Patients with a positive PCR test who were volunteered to participate in the project were included in the project
Each patient was assigned a random code
Kendall's table was designed by the computer, which has rows and columns, and the computer itself put numbers side each other randomly, a row and a column were randomly selected, and the intersection point of the row and column was sampled as the starting point. then the plus sign was drawn and all the numbers that were on it were selected as sample members of the intervention group. This process continued until 40 people were selected and other people were placed in the control group
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients were divided into two groups of 40 people, and the first intervention group received interferon beta in addition to the usual medical regime of Corona (Hydroxychlorquine and kaletra) and the second group (control) only received the usual medical regime. None of the groups knew which category they were in. has it
The patients received the drugs in the form of packs by one of the colleagues of the project and were blinded to the drugs in the pack
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti University of Medical Sciences
Street address
Faculty of Medicine - Shahid Beheshti University of Medical Sciences, Tehran, Quds town (West), between South Flamek and Zarafshan, Simai Iran St. - Ministry of Health, Treatment and Medical Education Central Headquarters
City
Tehran
Province
Tehran
Postal code
4631 19395
Approval date
2023-09-04, 1402/06/13
Ethics committee reference number
IR.SBMU.MSP.REC.1402.282
Health conditions studied
1
Description of health condition studied
Covid pneumonia
ICD-10 code
B97.2
ICD-10 code description
Coronavirus as the cause of disease
Primary outcomes
1
Description
Duration of hospitalization and ambient blood oxygen saturation percentage and duration of icu needed in patients who receive interferon
Timepoint
All the time spent in hospital
Method of measurement
Investigating the effect of interferon in the treatment of corona by calculating the percentage of ambient blood oxygen and the duration of hospitalization by pulse oximetry and observing the patient's clinical condition
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" people receiving recigen brand interferon beta with a dose of 12m iu eq daily for 5 days along with other common corona treatments including hydroxychloroquine 200 every 12 hours and kletra 400 (ritonavir/lopinavir) daily
Category
Treatment - Drugs
2
Description
: "Control group: "Hydroxychloroquine 200 mg every 12 hours and kaletra (lopinavir/ritonavir) at a dose of 400 mg daily on all days of hospitalization
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam hosein hospital
Full name of responsible person
Roya Rahmani
Street address
Imam Hossein Square, Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
Roya.rahmani89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Imam hossein hospital
Full name of responsible person
Shahin Salehi
Street address
Imam hossein square ,Shahid madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
Info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Imam hossein hospital
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Rahmani
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Tehranpars 198ave
City
Tehran
Province
Tehran
Postal code
1655753677
Phone
+98 912 465 5324
Email
Roya.rahmani89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Rahmani
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Tehranpars 198ave
City
Tehran
Province
Tehran
Postal code
1655753677
Phone
+98 912 465 5324
Email
Roya.rahmani89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Rahmani
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Tehranpars 198 ave
City
Tehran
Province
Tehran
Postal code
1655753677
Phone
+98 912 465 5324
Email
Roya.rahmani89@gmail.com
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Investigating the effect of interferon in the treatment of corona by calculating the percentage of ambient blood oxygen and the duration of hospitalization by pulse oximetry and observing the patient's clinical status and vital signs
When the data will become available and for how long
From the start of the project to the publication of the results
To whom data/document is available
Doctors active in the treatment of crona, universities of medical sciences of the country
Under which criteria data/document could be used
To be used in comparison with other corona treatment methods
From where data/document is obtainable
Roya rahmani
What processes are involved for a request to access data/document