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Protocol summary
The study is a single-blind clinical trial. The study population includes all patients with COVID-19 referring to Abadan, Khorramshahr and Shadegan hospitals. They visit the hospitals of Abadan, Khorramshahr and Shadegan and their testing is positive, involving 60 people, 30 of whom will be considered for both groups and will be selected using the census method.
The study is a open label , non-randomized and parallel clinical trial. The study population includes all patients with COVID-19 referring to Abadan, Khorramshahr and Shadegan hospitals. They visit the hospitals of Abadan, Khorramshahr and Shadegan and their testing is positive, involving 60 people, 30 of whom will be considered for both groups and will be selected using the census method.
The study is a singleopen label , non-blindrandomized and parallel clinical trial. The study population includes all patients with COVID-19 referring to Abadan, Khorramshahr and Shadegan hospitals. They visit the hospitals of Abadan, Khorramshahr and Shadegan and their testing is positive, involving 60 people, 30 of whom will be considered for both groups and will be selected using the census method.
مطالعه کارآزمایی بالینی یک سو کور می باشد، جامعه پژوهش شامل کلیه بیماران مبتلا به COVID-19 که به بیمارستان های آبادان ، خرمشهر و شادگان مراجعه می کنند و حجم نمونه در این مطالعه برابر است با جامعه پژوهشی ، یعنی تمام بیمارانی که در یک بازه زمانی به بیمارستان های آبادان ، خرمشهر و شادگان مراجعه می کنند و تست آنها مثبت می باشد که 60 نفر را شامل می شود که 30 نفر برای هر دو گروه در نظر گرفته خواهد شد و با استفاده از روش سرشماری انتخاب صورت خواهد گرفت .
مطالعه کارآزمایی بالینی کور نشده غیرتصادفی و موازی می باشد می باشد، جامعه پژوهش شامل کلیه بیماران مبتلا به COVID-19 که به بیمارستان های آبادان ، خرمشهر و شادگان مراجعه می کنند و حجم نمونه در این مطالعه برابر است با جامعه پژوهشی ، یعنی تمام بیمارانی که در یک بازه زمانی به بیمارستان های آبادان ، خرمشهر و شادگان مراجعه می کنند و تست آنها مثبت می باشد که 60 نفر را شامل می شود که 30 نفر برای هر دو گروه در نظر گرفته خواهد شد و با استفاده از روش سرشماری انتخاب صورت خواهد گرفت .
مطالعه کارآزمایی بالینی یک سو کور نشده غیرتصادفی و موازی می باشد می باشد، جامعه پژوهش شامل کلیه بیماران مبتلا به COVID-19 که به بیمارستان های آبادان ، خرمشهر و شادگان مراجعه می کنند و حجم نمونه در این مطالعه برابر است با جامعه پژوهشی ، یعنی تمام بیمارانی که در یک بازه زمانی به بیمارستان های آبادان ، خرمشهر و شادگان مراجعه می کنند و تست آنها مثبت می باشد که 60 نفر را شامل می شود که 30 نفر برای هر دو گروه در نظر گرفته خواهد شد و با استفاده از روش سرشماری انتخاب صورت خواهد گرفت .
The study is a single-blind clinical trial. The participants in this study are blind and the drug used in both groups is similar in appearance.was performed on 60 patients with severe symptoms of COVID-19 who were admitted to the infectious ward of Ayatollah Taleghani Hospital in Abadan and if they were hospitalized. These patients needed artificial ventilation and intubation and were admitted to the ICU ward for coronary patients.
The study was approved by the Ethics Committee of Abadan University of Medical Sciences. All patients eligible for inclusion in this study were adequately informed about the procedure and side effects of the drugs used, assured of the confidentiality of their information, and then a written consent was obtained. Patients also had the right to withdraw from the research team at any time.
the drug used in this study in both groups is similar in appearance.was performed on 60 patients with severe symptoms of COVID-19 who were admitted to the infectious ward of Ayatollah Taleghani Hospital in Abadan and if they were hospitalized. These patients needed artificial ventilation and intubation and were admitted to the ICU ward for coronary patients.
The study was approved by the Ethics Committee of Abadan University of Medical Sciences. All patients eligible for inclusion in this study were adequately informed about the procedure and side effects of the drugs used, assured of the confidentiality of their information, and then a written consent was obtained. Patients also had the right to withdraw from the research team at any time.
The study is a single-blind clinical trial. The participantsthe drug used in this study are blind and the drug used in both groups is similar in appearance.was performed on 60 patients with severe symptoms of COVID-19 who were admitted to the infectious ward of Ayatollah Taleghani Hospital in Abadan and if they were hospitalized. These patients needed artificial ventilation and intubation and were admitted to the ICU ward for coronary patients. The study was approved by the Ethics Committee of Abadan University of Medical Sciences. All patients eligible for inclusion in this study were adequately informed about the procedure and side effects of the drugs used, assured of the confidentiality of their information, and then a written consent was obtained. Patients also had the right to withdraw from the research team at any time.
در این مطالعه کارآزمایی بالینی یک سو کور می باشند. در این مطالعه شرکت کنندگان کور می باشد و داروی مورد استفاده در هر دوگروه قرص می باشد که از نظر شکل ظاهری مشابه می باشند. که بر روی 60 بیمار مبتلا به COVID-19 با علائم شدید که در بیمارستان آیت اله طالقانی شهر آبادان که به عنوان بیمارستان معین در نظر گرفته شده بود در بخش عفونی این بیمارستان بستری شدند و در صورتی که این بیماران به تهویه مصنوعی و لوله گذاری نیاز داشتند در بخش ICU مختص بیماران مبتلا به کرونا بستری شدند.
این مطالعه در کمیته اخلاق دانشگاه علوم پزشکی آبادان تصویب گردید . برای انجام این مطالعه به کلیه بیماران واجد شرایط ورود به این مطالعه توضیحات کافی در مورد روش کار و عوارض داروهای مورد استفاده داده شد و در خصوص حفظ محرمانگی اطلاعات آنها اطمینان خاطر داده شد و سپس رضایت نامه کتبی اخذ گردید. همچنین بیماران حق داشتند در هر زمانی از ادامه کار با گروه محققان انصراف دهند .
در این مطالعه داروی مورد استفاده در هر دوگروه قرص می باشد که از نظر شکل ظاهری مشابه می باشند. که بر روی 60 بیمار مبتلا به COVID-19 با علائم شدید که در بیمارستان آیت اله طالقانی شهر آبادان که به عنوان بیمارستان معین در نظر گرفته شده بود در بخش عفونی این بیمارستان بستری شدند و در صورتی که این بیماران به تهویه مصنوعی و لوله گذاری نیاز داشتند در بخش ICU مختص بیماران مبتلا به کرونا بستری شدند.
این مطالعه در کمیته اخلاق دانشگاه علوم پزشکی آبادان تصویب گردید . برای انجام این مطالعه به کلیه بیماران واجد شرایط ورود به این مطالعه توضیحات کافی در مورد روش کار و عوارض داروهای مورد استفاده داده شد و در خصوص حفظ محرمانگی اطلاعات آنها اطمینان خاطر داده شد و سپس رضایت نامه کتبی اخذ گردید. همچنین بیماران حق داشتند در هر زمانی از ادامه کار با گروه محققان انصراف دهند .
در این مطالعه کارآزمایی بالینی یک سو کور می باشند. در این مطالعه شرکت کنندگان کور می باشد و داروی مورد استفاده در هر دوگروه قرص می باشد که از نظر شکل ظاهری مشابه می باشند. که بر روی 60 بیمار مبتلا به COVID-19 با علائم شدید که در بیمارستان آیت اله طالقانی شهر آبادان که به عنوان بیمارستان معین در نظر گرفته شده بود در بخش عفونی این بیمارستان بستری شدند و در صورتی که این بیماران به تهویه مصنوعی و لوله گذاری نیاز داشتند در بخش ICU مختص بیماران مبتلا به کرونا بستری شدند. این مطالعه در کمیته اخلاق دانشگاه علوم پزشکی آبادان تصویب گردید . برای انجام این مطالعه به کلیه بیماران واجد شرایط ورود به این مطالعه توضیحات کافی در مورد روش کار و عوارض داروهای مورد استفاده داده شد و در خصوص حفظ محرمانگی اطلاعات آنها اطمینان خاطر داده شد و سپس رضایت نامه کتبی اخذ گردید. همچنین بیماران حق داشتند در هر زمانی از ادامه کار با گروه محققان انصراف دهند .
General information
Randomized
Not randomized
randnrand
Double blinded
Not blinded
doublnotbl
1
1
1
1
1
1
1
1
empty
Because of the plan condition randomization and blindness can't be done
Because of the plan condition randomization and blindness can't be done
empty
انجام تصادفی سازی و کور سازی با توجه به شرایط موجود مقدور نیست و در ضمن در پروپوزال ابتدایی هم این دو اصل در نظر گرفته نشده است
انجام تصادفی سازی و کور سازی با توجه به شرایط موجود مقدور نیست و در ضمن در پروپوزال ابتدایی هم این دو اصل در نظر گرفته نشده است
Method of randomization is 6 unit block randomization. Unit of randomization is individual. Tools for randomization is a computer software. sealed envelopes were used for allocation concealment
Method of randomization is 6 unit block randomization. Unit of randomization is individual. Tools for randomization is a computer software. sealed envelopes were used for allocation concealment
تصادفی سازی از نوع تصادفی سازی بلوکی که با استفاده از بلوک های 6 تایی انجام شد.
زنجیره تصادفی شده با استفاده از یک نرم افزار کامپیوتری بدست آمد. برای پنهان سازی زنجیره تصادفی شده از روش پاکت های در بسته استفاده شد.
تصادفی سازی از نوع تصادفی سازی بلوکی که با استفاده از بلوک های 6 تایی انجام شد. زنجیره تصادفی شده با استفاده از یک نرم افزار کامپیوتری بدست آمد. برای پنهان سازی زنجیره تصادفی شده از روش پاکت های در بسته استفاده شد.
Sovodac and Ribavirin are similar in shape and color
Sovodac and Ribavirin are similar in shape and color
داروهای سووداک و ریباویرین از نظر رنگ و شکل ظاهری مشابه می باشند
داروهای سووداک و ریباویرین از نظر رنگ و شکل ظاهری مشابه می باشند
Recruitment centers
#1
Name of recruitment center - English: Ayatollah taleghani hospital in abadan
Name of recruitment center - Persian: بیمارستان آیت الله طالقانی آبادان
Full name of responsible person - English: sara mobarak
Full name of responsible person - Persian: سارا مبارک
Street address - English: -
Street address - Persian: -
City - English: Abadan
City - Persian: آبادان
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6313833177
Phone: +98 61 5326 7800
Fax:
Email: s.mobarak@abadanums.ac.ir
Web page address:
Name of recruitment center - English: Ayatollah Taleghani Hospital in Abadan
Name of recruitment center - Persian: بیمارستان آیت الله طالقانی آبادان
Full name of responsible person - English: Sara Mobarak
Full name of responsible person - Persian: سارا مبارک
Street address - English: -Abadan School of Medical Sciences, Deputy of Education in front of Ayatollah Jamie Airport
Street address - Persian: دانشکده علوم پزشکی آبادان ، معاونت آموزشی روبروی فرودگاه آیت الله جمی
City - English: Abadan
City - Persian: آبادان
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6313833177
Phone: +98 61 5326 7800
Fax:
Email: s.mobarak@abadanums.ac.ir
Web page address:
Name of recruitment center - English: Ayatollah taleghani hospitalTaleghani Hospital in abadanAbadan Name of recruitment center - Persian: بیمارستان آیت الله طالقانی آبادان Full name of responsible person - English: sara mobarakSara Mobarak Full name of responsible person - Persian: سارا مبارک Street address - English: -Abadan School of Medical Sciences, Deputy of Education in front of Ayatollah Jamie Airport Street address - Persian: -دانشکده علوم پزشکی آبادان ، معاونت آموزشی روبروی فرودگاه آیت الله جمی City - English: Abadan City - Persian: آبادان Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6313833177 Phone: +98 61 5326 7800 Fax: Email: s.mobarak@abadanums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Sara Mobarak
Full name of responsible person - Persian: سارا مبارک
Street address - English: -
Street address - Persian: -
City - English: Abadan
City - Persian: آبادان
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6313833177
Phone: +98 61 5326 7800
Fax:
Email: s.mobarak@abadanums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Sara Mobarak
Full name of responsible person - Persian: سارا مبارک
Street address - English: -Abadan School of Medical Sciences, Deputy of Education in front of Ayatollah Jamie Airport
Street address - Persian: - دانشکده علوم پزشکی آبادان ، معاونت آموزشی روبروی فرودگاه آیت الله جمی
City - English: Abadan
City - Persian: آبادان
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6313833177
Phone: +98 61 5326 7800
Fax:
Email: s.mobarak@abadanums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Sara Mobarak Full name of responsible person - Persian: سارا مبارک Street address - English: -Abadan School of Medical Sciences, Deputy of Education in front of Ayatollah Jamie Airport Street address - Persian: - دانشکده علوم پزشکی آبادان ، معاونت آموزشی روبروی فرودگاه آیت الله جمی City - English: Abadan City - Persian: آبادان Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6313833177 Phone: +98 61 5326 7800 Fax: Email: s.mobarak@abadanums.ac.ir Web page address:
Protocol summary
Study aim
Comparison of the effect of two drugs Daclatasvir + Sofosbuvir and Ribavirin in COVID-19 patients with severe symptoms
Design
The study is a open label , non-randomized and parallel clinical trial. The study population includes all patients with COVID-19 referring to Abadan, Khorramshahr and Shadegan hospitals. They visit the hospitals of Abadan, Khorramshahr and Shadegan and their testing is positive, involving 60 people, 30 of whom will be considered for both groups and will be selected using the census method.
Settings and conduct
the drug used in this study in both groups is similar in appearance.was performed on 60 patients with severe symptoms of COVID-19 who were admitted to the infectious ward of Ayatollah Taleghani Hospital in Abadan and if they were hospitalized. These patients needed artificial ventilation and intubation and were admitted to the ICU ward for coronary patients.
The study was approved by the Ethics Committee of Abadan University of Medical Sciences. All patients eligible for inclusion in this study were adequately informed about the procedure and side effects of the drugs used, assured of the confidentiality of their information, and then a written consent was obtained. Patients also had the right to withdraw from the research team at any time.
Participants/Inclusion and exclusion criteria
Inclusion criteria: positive COVID-19 with severe symptoms
Exclusion criteria: Take a drug other than the medication mentioned
Intervention groups
The first group: Daclatasvir + Sofosbuvir
The second group: Ribavirin
Main outcome variables
Increased level of consciousness, normalized breathing rate, normalized blood pressure and improved arterial oxygen saturation and changes in laboratory factors, reduced gastrointestinal disorder, reduced number of days of hospitalization and reduced mortality.
General information
Reason for update
Because of the plan condition randomization and blindness can't be done
Acronym
IRCT registration information
IRCT registration number:IRCT20200324046850N2
Registration date:2020-03-29, 1399/01/10
Registration timing:registered_while_recruiting
Last update:2020-04-01, 1399/01/13
Update count:4
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Sara Mobarak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5326 7800
Email address
s.mobarak@abadanums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-18, 1398/12/28
Expected recruitment end date
2020-04-16, 1399/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Sofosbuvir + Daclatasvir (Sovodac) and Ribavirin in Covid-19 Patients with Severe Symptoms
Public title
Comparison of the effect of Sofosbuvir + Daclatasvir (Sovodac) and Ribavirin in Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 patients that have positive PCR test of nasopharyngeal sample or have bilateral multi-lobar ground glass opacity in CT scan
Exclusion criteria:
patients under 14 years
pregnant or breast feeding women
Age
From 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Abadan school of medical sciences
Street address
-Abadan School of Medical Sciences, Deputy of Education in front of Ayatollah Jamie Airport
City
Abadan
Province
Khouzestan
Postal code
6313833177
Approval date
2020-03-18, 1398/12/28
Ethics committee reference number
IR.ABADANUMS.REC.1398.113
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
2019-nCOV disease
Primary outcomes
1
Description
Number of people recovering from medication
Timepoint
14 days
Method of measurement
Improve symptoms
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Tablet Sovodak (Sufbosvir 400mg + Daclatasvir 60mg) daily for 5 days
Category
Treatment - Drugs
2
Description
Intervention group 2: Tablets Ribavirin 200 mg every 12 hours 1200mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital in Abadan
Full name of responsible person
Sara Mobarak
Street address
-Abadan School of Medical Sciences, Deputy of Education in front of Ayatollah Jamie Airport
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Email
s.mobarak@abadanums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Street address
-Abadan School of Medical Sciences, Deputy of Education in front of Ayatollah Jamie Airport
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Email
s.mobarak@abadanums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadan 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
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobark
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
infections diseases
Street address
Deputy of Education in front of Ayatollah Jamie Airport
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Email
s.mobarak@abadanums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infections diseases
Street address
- Deputy of Education in front of Ayatollah Jamie Airport
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Fax
Email
S.mobarak@abadanums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infections diseases
Street address
-Abadan School of Medical Sciences, Deputy of Education in front of Ayatollah Jamie Airport
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Fax
Email
S.mobarak@abadanums.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
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document