Evaluation of the effect of Betafron on reducing and preventing the progression of respiratory failure as well as organs failure and death of COVID-19 disease.
Design
Clinical trial with parallel control group , randomisation by balanced block method, phase 2 on 60 COVID-19 patients
Settings and conduct
60 COVID-19 patients admitted to Tabriz Imam Reza Hospital will be divided in 2 groups: treatment and control. In randomization by balanced block method, first,we will define quadruple blocks with group (A) and (B) arrangements, then we will select each of the blocks using the table of random numbers, and prepare 4 patients in the arrangement of (A) and (B) group in the selected block enrolled to the study. We will Continue this process to complete patients..Both groups will be treated by Hydroxychloroquine and Kaletra. In 30 intervention group patients , interferon beta 1 (zifron) 250 micrograms subcutaneously every other day for up to 5 doses will be added, but not in other 30 control group patients. Oxygenation, need for mechanical ventilation,and mortality will be monitored.
Outcome, considering improvement in respiratory failure, need for mechanical ventilation, and in hospital mortality will be compared in 2 groups.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1. Respiratory rate more than 24 per minute
2. Pao2 / FIO2 less than 300
exclusion criteria:
1. Pregnancy
2. History of allergy to interferon-beta 1 compounds (zifron)
3. History of advanced liver disease and liver enzymes three times normal
4. History of severe depression with suicidal thoughts
Intervention groups
30 patients in intervention group will be treated with antivirals and interferon beta1. And control group will be treated only with antivirals.
Main outcome variables
Arterial oxygen saturation
P / F ratio
mechanical ventilation
mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200406046968N3
Registration date:2020-05-08, 1399/02/19
Registration timing:registered_while_recruiting
Last update:2020-05-08, 1399/02/19
Update count:0
Registration date
2020-05-08, 1399/02/19
Registrant information
Name
Haleh Mikaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3329 6024
Email address
halehmikaeili@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-29, 1399/02/10
Expected recruitment end date
2020-06-30, 1399/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of Interfron-beta1(zifron) on clinical improvement and prognosis of COVID-19 in Tabriz Imam-Reza hospital
Public title
effect of Interfron-beta1(zifron) on clinical improvement and prognosis of COVID-19 in Tabriz Imam-Reza hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
respiratory rate> 24 / min
pao2 / Fio2< 300
Exclusion criteria:
Pregnancy
history of Sensitivity to interferon-beta 1 compounds (zifron)
History of advanced liver disease and liver enzymes three times normal
history of severe depression or suicidal thought
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by permuted (balanced) block randomization method. At the beginning, we will define quadruple blocks with group (a) and group (b) arrangements, and then we will select each of the blocks using the table of random numbers, and after each black determination, prepare 4 patients in the arrangement of(A) and (B) group in the selected block enrolled to the study. Then 4 other patients will be selected through the other block. We will Continue this process to complete patients.
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
Regional Research Ethics Committee (Humanities Studies)
Street address
Tabriz / Golgasht St. / Tabriz University of Medical Sciences Central Building No. 2 / Third Floor Deputy of Research and Technology
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-04-13, 1399/01/25
Ethics committee reference number
IR.TBZMED.REC.1399.019
Health conditions studied
1
Description of health condition studied
COVID-19 diseaese
ICD-10 code
U07.2
ICD-10 code description
COVID-19, virus not identified
Primary outcomes
1
Description
oxygenation
Timepoint
daily
Method of measurement
pulse oximetery
Secondary outcomes
1
Description
P/F ratio
Timepoint
daily
Method of measurement
ABG
2
Description
need for mechanical ventilation
Timepoint
daily
Method of measurement
file
3
Description
in hospital mortality
Timepoint
daily
Method of measurement
file
Intervention groups
1
Description
Intervention group: 30 COVID-19 patients with inclusion criteria will be treated with 250 micro grams of betafron (Zifron Zist Darou Danesh) Subcutaneously every other day up to 10 days or 5 dosages in addition to antivirals including hydroxychloroquine 400 mg,bid stat. and Kaletra 2 tablet bid for 10 days.
Category
Treatment - Drugs
2
Description
Control group: 30 COVID-19 patients will be treated only with antivirals including hydroxychloroquine 400 mg,bid stat and Kaletra 2 tablet bid for 10 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mikaeili Haleh
Street address
University Street in front of the Central Organization of Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7059
Email
info@imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zist Daru Danesh Company
Full name of responsible person
Hooshmand Ilka
Street address
No. 33, First Floor, Corner of Siboyeh St., Ibn Yamin St., North Sohrevardi St.
City
Tehran
Province
Tehran
Postal code
1555633114
Phone
+98 21 4231 8100
Email
info@zistdaru.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zist Daru Danesh Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mikaeili Haleh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
3rd Floor, Central Building, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5157679746
Phone
+98 41 3329 6024
Email
halehmikaeili@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mikaeili Haleh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
3rd Floor, Central Building, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5157679746
Phone
+98 41 3329 6024
Email
halehmikaeili@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mikaeili haleh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
3rd Floor, Central Building, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5157679746
Phone
+98 41 3329 6024
Email
halehmikaeili@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
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 related to the study of the effect of interferon-beta 1 (zifron) on clinical improvement and prognosis of patients with COVID-19 will be shared in Imam Reza (AS) Hospital in Tabriz.
When the data will become available and for how long
Since the summer of 1399
To whom data/document is available
Researchers and all treatment staff
Under which criteria data/document could be used
For treatment
From where data/document is obtainable
Dr. Mikaeili haleh
What processes are involved for a request to access data/document