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Protocol summary
Evaluating efficacy and safety of interferone β-1a in the treatment COVID-19 infection
Evaluating efficacy and safety of interferone β-1b (IFN β-1b) in the treatment of COVID-19
Evaluating efficacy and safety of interferone β-1a1b (IFN β-1b) in the treatment of COVID-19 infection
بررسی اثربخشی و ایمنی اینترفرون بتا-1 بی (IFN Β-1B) در درمان عفونت COVID-19
بررسی اثربخشی و ایمنی اینترفرون بتا-1 بی (IFN β-1b) در درمان
COVID-19
بررسی اثربخشی و ایمنی اینترفرون بتا-1 بی (IFN Ββ-1B1b) در درمان عفونت COVID-19
Inclusion criteria: 18-75 years old persons Highly suspected of confirmed COVID-19 infection
Exclusion criteria: History of drug allergy Uncontrolled baseline diseases including neuropsychiatric disorders, thyroid disorders, heart disease Pregnancy and lactation
Baseline liver failure
Inclusion criteria:
18-75 years old persons with highly suspected or confirmed COVID-19
Exclusion criteria:
History of drug allergy
Uncontrolled baseline diseases including neuropsychiatric disorders, thyroid disorders, heart disease
Pregnancy and lactation
Baseline liver failure
Inclusion criteria: 18-75 years old persons Highlywith highly suspected ofor confirmed COVID-19 infection Exclusion criteria: History of drug allergy Uncontrolled baseline diseases including neuropsychiatric disorders, thyroid disorders, heart disease Pregnancy and lactation Baseline liver failure
معیارهای ورود به مطالعه: افراد 18 تا 75 سال شک بالا و یا تاییدCOVID-19
معیارهای خروج از مطالعه: سابقه آلرژی دارویی
بیماری زمینه ای کنترل نشده شامل مشکلات عصبی-روانی، دیابت، اختلالات تیروئیدی، بیماری قلبی
بارداری و شیر دهی
نارسایی کبدی زمینه ای
معیارهای ورود به مطالعه:
افراد 18 تا 75 سال با شک بالا یا تایید COVID-19
معیارهای خروج از مطالعه:
سابقه آلرژی دارویی
بیماری زمینه ای کنترل نشده شامل مشکلات عصبی-روانی، دیابت، اختلالات تیروئیدی، بیماری قلبی
بارداری و شیر دهی
نارسایی کبدی زمینه ای
معیارهای ورود به مطالعه: افراد 18 تا 75 سال با شک بالا و یا تاییدCOVIDتایید COVID-19 معیارهای خروج از مطالعه: سابقه آلرژی دارویی بیماری زمینه ای کنترل نشده شامل مشکلات عصبی-روانی، دیابت، اختلالات تیروئیدی، بیماری قلبی بارداری و شیر دهی نارسایی کبدی زمینه ای
Concomitant with the national proposed combination, the intervention group will receive interferon B 1a, 44 mcg subcutaneously every other day for 14 days. Patents in the control group will receive only the national proposed combination. Patients will be followed every other day for response to the treatment and adverse reactions up to the end of treatment.
Concomitant with the national proposed combination, the intervention group will receive interferon β-1b (Zist Daru Daneh Company), 250 mcg subcutaneously every other day for 14 days. Patents in the control group will receive only the national proposed combination. Patients will be followed every other day for response to the treatment and adverse reactions up to the end of treatment.
Concomitant with the national proposed combination, the intervention group will receive interferon B 1aβ-1b (Zist Daru Daneh Company), 44250 mcg subcutaneously every other day for 14 days. Patents in the control group will receive only the national proposed combination. Patients will be followed every other day for response to the treatment and adverse reactions up to the end of treatment.
بیماران گروه مداخله علاوه به ترکیب پیشنهادی کمیته کشوری، اینترفرون بتا یک ای با دوز 44 میکروگرم یکروز درمیان بصورت تزریق زیر جلدی برای مدت 14 روز دریافت می کنند. گروه کنترل تنها رژیم پیشنهادی کمیته کشوری را دریافت می کنند. بیماران بصورت یکروز درمیان از نظر پاسخ به درمان و عوارض جانبی تا انتهای درمان پی گیری می شوند.
بیماران گروه مداخله علاوه به ترکیب پیشنهادی کمیته کشوری، اینترفرون بتا یک بی (شرکت زیست دارو دانش) با دوز 250 میکروگرم یکروز درمیان بصورت تزریق زیر جلدی برای مدت 14 روز دریافت می کنند. گروه کنترل تنها رژیم پیشنهادی کمیته کشوری را دریافت می کنند. بیماران بصورت یکروز درمیان از نظر پاسخ به درمان و عوارض جانبی تا انتهای درمان پی گیری می شوند.
بیماران گروه مداخله علاوه به ترکیب پیشنهادی کمیته کشوری، اینترفرون بتا یک ایبی (شرکت زیست دارو دانش) با دوز 44250 میکروگرم یکروز درمیان بصورت تزریق زیر جلدی برای مدت 14 روز دریافت می کنند. گروه کنترل تنها رژیم پیشنهادی کمیته کشوری را دریافت می کنند. بیماران بصورت یکروز درمیان از نظر پاسخ به درمان و عوارض جانبی تا انتهای درمان پی گیری می شوند.
General information
empty
Change sub-type of interferon from 1a to 1b in title and interventions section
Change sub-type of interferon from 1a to 1b in title and interventions section
empty
تغییر ساب تایپ اینترفرون از یک ای به یک بی در عنوان و قسمت مداخلات
تغییر ساب تایپ اینترفرون از یک ای به یک بی در عنوان و قسمت مداخلات
Interferon B in treatment of COVID-19
Interferon β in treatment of COVID-19
Interferon Bβ in treatment of COVID-19
Evaluating efficacy and safety of interferone β-1a in the treatment COVID-19 infection
Evaluating efficacy and safety of interferone β-1b (IFN β-1b) in the treatment of COVID-19
Evaluating efficacy and safety of interferone β-1a1b (IFN β-1b) in the treatment of COVID-19 infection
بررسی اثربخشی و ایمنی اینترفرون بتا-1 بی (IFN Β-1B) در درمان عفونت COVID-19
بررسی اثربخشی و ایمنی اینترفرون بتا-1 بی (IFN β-1b) در درمان COVID-19
بررسی اثربخشی و ایمنی اینترفرون بتا-1 بی (IFN Ββ-1B1b) در درمان عفونت COVID-19
Patients with highly suspected or confirmed COVID-19 infection who are candid for hospitalization and starting triple-drug combination
Patients with highly suspected or confirmed COVID-19 who are candid for hospitalization and starting triple-drug combination.
Patients with highly suspected or confirmed COVID-19 infection who are candid for hospitalization and starting triple-drug combination.
بیماران با شک بالا یا تایید عفونت COVID-19 که کاندید بستری و شروع ترکیب سه دارویی دارند.
بیماران با شک بالا یا تایید COVID-19 که کاندید بستری و شروع ترکیب سه دارویی دارند.
بیماران با شک بالا یا تایید عفونت COVID-19 که کاندید بستری و شروع ترکیب سه دارویی دارند.
History of drug allergy
Pregnancy and lactation
uncontrolled baseline diseases including neuropsychiatric disorders, thyroid disorders, heart disease Pregnancy ,Baseline liver failure
History of drug allergy
Pregnancy and lactation
Uncontrolled baseline diseases including neuropsychiatric disorders, diabetes, thyroid disorders, heart disease, baseline liver failure
History of drug allergy Pregnancy and lactation uncontrolledUncontrolled baseline diseases including neuropsychiatric disorders, diabetes, thyroid disorders, heart disease Pregnancy ,Baseline baseline liver failure
سابقه آلرژی دارویی
بارداری , و شیر دهی
بیماری زمینه ای کنترل نشده شامل مشکلات عصبی-روانی، دیابت، اختلالات تیروئیدی، بیماری قلبی بارداری، نارسایی کبدی زمینه ای
سابقه آلرژی دارویی
بارداری , و شیر دهی
بیماری زمینه ای کنترل نشده شامل مشکلات عصبی-روانی، دیابت، اختلالات تیروئیدی، بیماری قلبی، نارسایی کبدی زمینه ای
سابقه آلرژی دارویی بارداری , و شیر دهی بیماری زمینه ای کنترل نشده شامل مشکلات عصبی-روانی، دیابت، اختلالات تیروئیدی، بیماری قلبی بارداری، نارسایی کبدی زمینه ای
Intervention groups
#1
Intervention group: Concomitant with the national corona treatment recommendation(hydroxychloroquine + Oseltamivir +Lopinavir/ritonavir), patients will receive interferon B, subtype 1b with dose of 250 mcg subcutaneously every other day for 14 days.
Intervention group: Concomitant with the national corona treatment recommendation (hydroxychloroquine + oseltamivir +lopinavir/ritonavir), patients will receive interferon β, sub-type 1b with dose of 250 mcg subcutaneously every other day for 14 days.
Intervention group: Concomitant with the national corona treatment recommendation(hydroxychloroquinerecommendation (hydroxychloroquine + Oseltamiviroseltamivir +Lopinavirlopinavir/ritonavir), patients will receive interferon Bβ, subtypesub-type 1b with dose of 250 mcg subcutaneously every other day for 14 days.
گروه مداخله: بیماران در کنار توصیه های درمانی کمیته کشوری کرونا (هیدروکسیکلروکین + اوسلتامیویر + لوینناویر/ریتوناویر)، اینترفرون بتا ساب تایپ یک بی به میزان 250 میکروگرم بصورت تزریق زیر جلدی بصورت یکروز درمیان برای 14 روز دریافت خواهندنمود.
گروه مداخله: بیماران در کنار توصیه های درمانی کمیته کشوری کرونا (هیدروکسی کلروکین + اوسلتامیویر + لوپیناویر/ریتوناویر)، اینترفرون بتا ساب تایپ یک بی به میزان 250 میکروگرم بصورت تزریق زیر جلدی بصورت یکروز درمیان برای 14 روز دریافت خواهندنمود.
گروه مداخله: بیماران در کنار توصیه های درمانی کمیته کشوری کرونا (هیدروکسیکلروکینهیدروکسی کلروکین + اوسلتامیویر + لوینناویرلوپیناویر/ریتوناویر)، اینترفرون بتا ساب تایپ یک بی به میزان 250 میکروگرم بصورت تزریق زیر جلدی بصورت یکروز درمیان برای 14 روز دریافت خواهندنمود.
#2
Control group: Patients will receive the national corona treatment recommendation(hydroxychloroquine + Oseltamivir +Lopinavir/ritonavir) for at least 5 days.
Control group: Patients will receive the national corona treatment recommendation (hydroxychloroquine + oseltamivir +Lopinavir/ritonavir) for at least 5 days.
Control group: Patients will receive the national corona treatment recommendation(hydroxychloroquinerecommendation (hydroxychloroquine + Oseltamiviroseltamivir +Lopinavir/ritonavir) for at least 5 days.
گروه کنترل: بیماران توصیه های درمانی کمیته کشوری کرونا (هیدروکسی کلروکین +اوسلتامیویر + لوینناویر/ریتوناویر) را حداقل برای 5 روز دریافت می کنند.
گروه کنترل: بیماران توصیه های درمانی کمیته کشوری کرونا (هیدروکسی کلروکین +اوسلتامیویر + لوپیناویر/ریتوناویر) را حداقل برای 5 روز دریافت می کنند.
گروه کنترل: بیماران توصیه های درمانی کمیته کشوری کرونا (هیدروکسی کلروکین +اوسلتامیویر + لوینناویرلوپیناویر/ریتوناویر) را حداقل برای 5 روز دریافت می کنند.
Protocol summary
Study aim
Evaluating efficacy and safety of interferone β-1b (IFN β-1b) in the treatment of COVID-19
Design
This is a non-blinded randomized clinical trial.Included patients will be assigned to intervention or control group according the permuted block randomization.
Settings and conduct
This study will be done in Imam Khomeini Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
18-75 years old persons with highly suspected or confirmed COVID-19
Exclusion criteria:
History of drug allergy
Uncontrolled baseline diseases including neuropsychiatric disorders, thyroid disorders, heart disease
Pregnancy and lactation
Baseline liver failure
Intervention groups
Concomitant with the national proposed combination, the intervention group will receive interferon β-1b (Zist Daru Daneh Company), 250 mcg subcutaneously every other day for 14 days. Patents in the control group will receive only the national proposed combination. Patients will be followed every other day for response to the treatment and adverse reactions up to the end of treatment.
Main outcome variables
Primary endpoints of the study are rates of treatment response and adverse drug reactions.
Secondary endpoints are duration of hospitalization and patients' clinical outcomes.
General information
Reason for update
Change sub-type of interferon from 1a to 1b in title and interventions section
Acronym
IRCT registration information
IRCT registration number:IRCT20100228003449N27
Registration date:2020-03-16, 1398/12/26
Registration timing:registered_while_recruiting
Last update:2020-03-19, 1398/12/29
Update count:2
Registration date
2020-03-16, 1398/12/26
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-15, 1398/12/25
Expected recruitment end date
2020-05-14, 1399/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating efficacy and safety of interferone β-1b (IFN β-1b) in the treatment of COVID-19
Public title
Interferon β in treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with highly suspected or confirmed COVID-19 who are candid for hospitalization and starting triple-drug combination.
Exclusion criteria:
History of drug allergy
Pregnancy and lactation
Uncontrolled baseline diseases including neuropsychiatric disorders, diabetes, thyroid disorders, heart disease, baseline liver failure
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with inclusion criteria of the study will be recruited in the intervention or the control group according the permuted block randomization (5 blocks and 3 patients in each block)
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
Ethics Committee of Tehran University Of Medical Sciences
Street address
Ghods Ave. Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2020-03-14, 1398/12/24
Ethics committee reference number
IR.TUMS.VCR.REC.1398.1053
Health conditions studied
1
Description of health condition studied
COVID-19 pneumonia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Response to the treatment
Timepoint
Daily
Method of measurement
According the clinical, paraclinical and laboratory findings
2
Description
Complications of the treatment
Timepoint
Daily
Method of measurement
Interview and patient's record
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
End of the treatment
Method of measurement
Patient's record
2
Description
Clinical outcome
Timepoint
End of treatment
Method of measurement
Patient's record
Intervention groups
1
Description
Intervention group: Concomitant with the national corona treatment recommendation (hydroxychloroquine + oseltamivir +lopinavir/ritonavir), patients will receive interferon β, sub-type 1b with dose of 250 mcg subcutaneously every other day for 14 days.
Category
Treatment - Drugs
2
Description
Control group: Patients will receive the national corona treatment recommendation (hydroxychloroquine + oseltamivir +Lopinavir/ritonavir) for at least 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Hossein Khalili
Street address
Keshavarz Boulveard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Ghods Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
02166706141
Phone
+98 21 8898 7381
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript
When the data will become available and for how long
One year after finishing the study, data will be published and will be available in databases
To whom data/document is available
After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes
Under which criteria data/document could be used
Other researchers are permitted to included the results in their systematic reviews and
metaanalysis
From where data/document is obtainable
For this you may ask Hossein Khalili through following information: Address: Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave.,Tehran, Iran Postal code: 1417614411 E-mail: khalilih@tums.ac.ir
What processes are involved for a request to access data/document
After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks