1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of Sofosbuvir + Daclatasvir (Sovodac) and Ribavirin in Covid-19 Patients with Severe Symptoms

View the latest revision

History
# Registration date Revision Id
5 2020-04-29, 1399/02/10 132105
4 2020-04-08, 1399/01/20 131580
3 2020-04-06, 1399/01/18 128487
2 2020-03-31, 1399/01/12 127594
1 2020-03-29, 1399/01/10 127304
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    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 open label , non-randomized and parallel clinical trial. The study population includes all patients with COVID-19 referring to Abadan hospitals. All patients who refer to Abadan hospitals in a period of time and their testing is positive, which includes 62 people, who will be in two groups: Doclatasavir + Sophosbovir and Ribavirin.
    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 کور نشده غیرتصادفی و موازی می باشد، جامعه پژوهش شامل کلیه بیماران مبتلا به COVID-19 که به بیمارستان های آبادان 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 مراجعه می کنند و تست آنها مثبت می باشد که 62 نفر را شامل می شود که در دو گروه داکلاتاسویر + سوفوسبوویر و ریباویرین قرار خواهند گرفت.
    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 drug used in this study in both groups is similar in appearance.was performed on 62 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. 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 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 62 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. 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 .
    Inclusion criteria: positive COVID-19 with severe symptoms Exclusion criteria: Take a drug other than the medication mentioned
    Inclusion criteria: positive COVID-19 with severe symptoms and positive RT-PCR assay of nasopharyngeal samples Exclusion criteria: patients under 18 years, pregnant and breast feeding women
    معیار ورود: بیماران کرونا مثبت با علائم شدید معیار خروج: دریافت دارویی غیر از رژیم دارویی ذکر شده
    معیار ورود: بیماران کرونا مثبت با علائم شدید , تست PCR مثبت از نمونه های نازوفارنکس معیار خروج: بیماران زیر 18 سال، زنان باردار و شیرده
    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.
    level of consciousness, Respiratory rate, blood pressure and arterial oxygen saturation and changes in laboratory factors, gastrointestinal disorder, number of days of hospitalization and mortality rate.
    افزایش سطح هوشیاری ، نرمال شدن تعداد تنفس ، نرمال شدن فشارخون و بهبود اشباع اکسیژن خون شریانی و تغییرات فاکتورهای آزمایشگاهی ، کاهش اختلالات گوارشی ، کاهش تعداد روزهای بستری و کاهش میزان مرگ و میر
    سطح هوشیاری ، تعداد تنفس ، فشارخون و اشباع اکسیژن خون شریانی و تغییرات فاکتورهای آزمایشگاهی ، اختلالات گوارشی ، تعداد روزهای بستری و میزان مرگ و میر

  • General information

    14
    18
    60
    62
    Because of the plan condition randomization and blindness can't be done
    Explain the release schedule as well as update the primary and secondary variables
    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
    توضیح برنامه انتشار و همچنین بروز رسانی متغیرهای اولیه و ثانویه
    COVID-19 patients that have positive PCR test of nasopharyngeal sample or have bilateral multi-lobar ground glass opacity in CT scan
    COVID-19 patients that have positive PCR test of nasopharyngeal sample or have bilateral multi-lobar ground glass opacity in CT scan
    O2 saturation under 94% or respiratory rate above 24 or decreased level of consciousness
    بیمارانی covid-19 که بیماری آنها به وسیله PCR نمونه ته حلق مثبت شده است یا در سی تی اسکن نمای گراند گلس مولتی لوبار دوطرفه دارند.
    بیمارانی covid-19 که بیماری آنها به وسیله PCR نمونه ته حلق مثبت شده است یا در سی تی اسکن نمای گراند گلس مولتی لوبار دوطرفه دارند.
    اشباع O2 زیر 94٪ یا میزان تنفس بالاتر از 24 یا کاهش سطح هوشیاری
    patients under 14 years
    pregnant or breast feeding women
    patients under 18 years
    pregnant or breast feeding women
    patients did not consent to participate in the study
    patients who took any complementary medicine
    safety problem for patients
    patients with any allergy or hypersensitivity to Sofosbuvir + Daclatasvir or Ribavirin or with major interaction with other medicine
    بیماران زیر 14 سال
    زنان باردار و شیرده
    بیماران زیر 18 سال
    زنان باردار و شیرده
    بیمارانی که از شرکت در این مطالعه رضایت ندارند ، ،
    بیمارانی با مصرف هرگونه داروی مکمل
    بیماران با مشکل ایمنی
    بیماران مبتلا به هرگونه حساسیت یا حساسیت به Sofosbuvir + Daclatasvir یا Ribavirin یا با تداخل عمده با داروهای دیگر

  • Primary outcomes

    #1
    Number of people recovering from medication
    Time to clinical improvement defined as start of taking medication time to alive hospital discharge
    تعداد افراد بهبود یافته در اثر دریافت دارو
    زمان بهبود علائم بالینی که از زمان شروع مصرف دارو تا ترخیص بیمار در نظر گرفته می شود.
    14 days
    The beginning of the study , the time of discharge and 21 days after discharge
    14 روز
    ابتدای مطالعه، زمان ترخیص و 21 روز بعد از ترخیص
    Improve symptoms
    Medical record
    بهبود علایم بیماری
    پرونده بیمار

  • Secondary outcomes

    #1
    empty
    Duration of hospitalization
    empty
    مدت زمان بستری
    empty
    Time of discharge
    empty
    زمان ترخیص
    empty
    Number of hospital days
    empty
    شمارش روزهای بستری
    #2
    empty
    Duration of stay at ICU
    empty
    مدت زمان بستری در ICU
    empty
    Daily
    empty
    روزانه
    empty
    Number of days of hospitalization in ICU
    empty
    شمارش روزهای بستری در ICU
    #3
    empty
    Mortality rate
    empty
    میزان مرگ و میر
    empty
    Daily
    empty
    روزانه
    empty
    Medical record
    empty
    پرونده بیمار
    #4
    empty
    Respiratory rate
    empty
    تعداد تنفس
    empty
    Daily
    empty
    روزانه
    empty
    Count the number of breaths per minute
    empty
    شمارش تعداد تنفس در یک دقیقه
    #5
    empty
    laboratory variables
    empty
    متغیرهای آزمایشگاهی
    empty
    The beginning of the study and the time of discharge
    empty
    ابتدای مطالعه و زمان ترخیص
    empty
    Medical record
    empty
    پرونده بیمار
    #6
    empty
    Adverse events
    empty
    عوارض جانبی
    empty
    Time of discharge
    empty
    زمان ترخیص
    empty
    Medical record
    empty
    پرونده بیمار

  • Intervention groups

    #1
    Intervention group 1: Tablet Sovodak (Sufbosvir 400mg + Daclatasvir 60mg) daily for 5 days
    lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose + sofosbuvir (400 mg)- daclatasvir (60 mg) take one tablet daily until clinical symptoms improve
    گروه مداخله اول : قرص سووداک (سوفوسبوویر 400mg + داکلاتاسویر60mg ) روزانه یک قرص به مدت 5 روز
    گروه مداخله اول : قرص کلترا (لوپیناویر 50mg/ ریتوناویر200mg ) هر 12 ساعت 2 عدد تا بهبود علائم بالینی بیمار، قرص هیدروکسی کلروکین سولفات 200mg دو عدد تک دز ، (سوفوسبوویر 400mg / داکلاتاسویر 60mg )روزانه یک قرص تا بهبود علائم بالینی
    #2
    Intervention group 2: Tablets Ribavirin 200 mg every 12 hours 1200mg
    Intervention group 2: lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose + ribavirin (200 mg) 6 tablets every 12 hours until clinical symptoms improve
    گروه مداخله دوم : قرص ریباویرین 200 mg هر 12 ساعت 6 عدد به مدت 5 روز
    گروه مداخله دوم : قرص کلترا (لوپیناویر 50mg/ ریتوناویر200mg ) هر 12 ساعت 2 عدد تا بهبود علائم بالینی بیمار، قرص هیدروکسی کلروکین سولفات 200mg دو عدد تک دز ، قرص ریباویرین 200 mg هر 12 ساعت 6 عدد تا بهبود علائم بالینی

  • Sharing plan

    -
    -All data can be shared after the participants in the study are unrecognizable.
    -
    کل داده ها پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است.
    -
    -Data access period begins three months after the article is published
    -
    - شروع دوره دسترسی به داده ها سه ماه بعد از چاپ مقاله
    -
    -The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration.
    -
    - داده های این مطالعه برای محققین شاغل در موسسات دانشگاهی و علمی و همچنین سازمان غذا و دارو قابل دسترس خواهد بود.
    -
    - Any analysis can be done with the consent of the main researcher.
    -
    - انجام هر گونه آنالیز با رضایت محقق اصلی میتواند انجام شود.
    -
    -s.mobarak@abadanums.ac.ir
    -
    s.mobarak@abadanums.ac.ir
    -
    -The researcher or pharmaceutical company can send their request to the academic email after sending the documents to confirm their original identity.
    -
    - فرد محقق و یا شرکت دارویی بعد از ارسال مستندات جهت تایید هویت اصلی خود می تواند درخواست خود را به ایمیل آکادمیک ارسال نماید .

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 hospitals. All patients who refer to Abadan hospitals in a period of time and their testing is positive, which includes 62 people, who will be in two groups: Doclatasavir + Sophosbovir and Ribavirin.
Settings and conduct
the drug used in this study in both groups is similar in appearance.was performed on 62 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. 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 and positive RT-PCR assay of nasopharyngeal samples Exclusion criteria: patients under 18 years, pregnant and breast feeding women
Intervention groups
The first group: Daclatasvir + Sofosbuvir The second group: Ribavirin
Main outcome variables
level of consciousness, Respiratory rate, blood pressure and arterial oxygen saturation and changes in laboratory factors, gastrointestinal disorder, number of days of hospitalization and mortality rate.

General information

Reason for update
Explain the release schedule as well as update the primary and secondary variables
Acronym
IRCT registration information
IRCT registration number: IRCT20200324046850N2
Registration date: 2020-03-29, 1399/01/10
Registration timing: registered_while_recruiting

Last update: 2020-04-27, 1399/02/08
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 O2 saturation under 94% or respiratory rate above 24 or decreased level of consciousness
Exclusion criteria:
patients under 18 years pregnant or breast feeding women patients did not consent to participate in the study patients who took any complementary medicine safety problem for patients patients with any allergy or hypersensitivity to Sofosbuvir + Daclatasvir or Ribavirin or with major interaction with other medicine
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 62
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
Time to clinical improvement defined as start of taking medication time to alive hospital discharge
Timepoint
The beginning of the study , the time of discharge and 21 days after discharge
Method of measurement
Medical record

Secondary outcomes

1

Description
Duration of hospitalization
Timepoint
Time of discharge
Method of measurement
Number of hospital days

2

Description
Duration of stay at ICU
Timepoint
Daily
Method of measurement
Number of days of hospitalization in ICU

3

Description
Mortality rate
Timepoint
Daily
Method of measurement
Medical record

4

Description
Respiratory rate
Timepoint
Daily
Method of measurement
Count the number of breaths per minute

5

Description
laboratory variables
Timepoint
The beginning of the study and the time of discharge
Method of measurement
Medical record

6

Description
Adverse events
Timepoint
Time of discharge
Method of measurement
Medical record

Intervention groups

1

Description
lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose + sofosbuvir (400 mg)- daclatasvir (60 mg) take one tablet daily until clinical symptoms improve
Category
Treatment - Drugs

2

Description
Intervention group 2: lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose + ribavirin (200 mg) 6 tablets every 12 hours until clinical symptoms improve
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
-All data can be shared after the participants in the study are unrecognizable.
When the data will become available and for how long
-Data access period begins three months after the article is published
To whom data/document is available
-The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration.
Under which criteria data/document could be used
- Any analysis can be done with the consent of the main researcher.
From where data/document is obtainable
-s.mobarak@abadanums.ac.ir
What processes are involved for a request to access data/document
-The researcher or pharmaceutical company can send their request to the academic email after sending the documents to confirm their original identity.
Comments
-
Loading...