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General information
Edit the sponsorship section
Edit the Recruitment centers
Edit the sponsorship sectionRecruitment centers
ویرایش بخش حمایت مالی
ویرایش بخش مراکز بیمارگیری
ویرایش بخش حمایت مالیمراکز بیمارگیری
Recruitment centers
#1
Name of recruitment center - English: Iranshahr
Name of recruitment center - Persian: ایرانشهر
Full name of responsible person - English: Fateme Azarkish
Full name of responsible person - Persian: فاطمه آذرکیش
Street address - English: Baluch St. Deputy of Research and Technology, Sistan and Baluchestan Province, Iranshahr
Street address - Persian: خیابان بلوچ معاونت تحقیقات و فناوری ،استان سیستان و بلوچستان،ایرانشهر، دانشگاه علوم پزشکی ایرانشهر
City - English: Iranshahr
City - Persian: ایرانشهر
Province: Sistan-va-Balouchestan
Country: Iran (Islamic Republic of)
Postal code: ۹۹۱۴۷۸۶۱۳۸
Phone: +98 54 3721 3328
Fax:
Email: Azarkish2005@yahoo.com
Web page address:
Name of recruitment center - English: Iranshahr Name of recruitment center - Persian: ایرانشهر Full name of responsible person - English: Fateme Azarkish Full name of responsible person - Persian: فاطمه آذرکیش Street address - English: Baluch St. Deputy of Research and Technology, Sistan and Baluchestan Province, Iranshahr Street address - Persian: خیابان بلوچ معاونت تحقیقات و فناوری ،استان سیستان و بلوچستان،ایرانشهر، دانشگاه علوم پزشکی ایرانشهر City - English: Iranshahr City - Persian: ایرانشهر Province: Sistan-va-Balouchestan Country: Iran (Islamic Republic of) Postal code: ۹۹۱۴۷۸۶۱۳۸ Phone: +98 54 3721 3328 Fax: Email: Azarkish2005@yahoo.com Web page address:
#2
Name of recruitment center - English: Shiraz
Name of recruitment center - Persian: شیراز
Full name of responsible person - English: Zinab mehraby
Full name of responsible person - Persian: زینب محرابی
Street address - English: Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences, Shiraz
Street address - Persian: شیراز,خیابان زند,روبروی خیابان فلسطین,ساختمان مرکزی دانشگاه علوم پزشکی شیراز
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 1433671348
Phone: +98 71 3230 5410
Fax:
Email: mehrabizm4510@gmail.com
Web page address:
Name of recruitment center - English: Shiraz Name of recruitment center - Persian: شیراز Full name of responsible person - English: Zinab mehraby Full name of responsible person - Persian: زینب محرابی Street address - English: Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences, Shiraz Street address - Persian: شیراز,خیابان زند,روبروی خیابان فلسطین,ساختمان مرکزی دانشگاه علوم پزشکی شیراز City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 1433671348 Phone: +98 71 3230 5410 Fax: Email: mehrabizm4510@gmail.com Web page address:
#3
Name of recruitment center - English: Bandar Abbas
Name of recruitment center - Persian: بندرعباس
Full name of responsible person - English: Elham Barahimi
Full name of responsible person - Persian: الهام براهیمی
Street address - English: Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran
Street address - Persian: ایران ، بندر عباس ، مرکز تحقیقات بیماریهای عفونی و گرمسیری ، موسسه بهداشتی هرمزگان ، دانشگاه علوم پزشکی هرمزگان
City - English: Bandar Abbas
City - Persian: بندرعباس
Province: Hormozgan
Country: Iran (Islamic Republic of)
Postal code: 7916613885
Phone: +98 76 3371 0373
Fax:
Email: dr.e.barahimi@gmail.com
Web page address:
Name of recruitment center - English: Bandar Abbas Name of recruitment center - Persian: بندرعباس Full name of responsible person - English: Elham Barahimi Full name of responsible person - Persian: الهام براهیمی Street address - English: Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran Street address - Persian: ایران ، بندر عباس ، مرکز تحقیقات بیماریهای عفونی و گرمسیری ، موسسه بهداشتی هرمزگان ، دانشگاه علوم پزشکی هرمزگان City - English: Bandar Abbas City - Persian: بندرعباس Province: Hormozgan Country: Iran (Islamic Republic of) Postal code: 7916613885 Phone: +98 76 3371 0373 Fax: Email: dr.e.barahimi@gmail.com Web page address:
#4
Name of recruitment center - English: Gheshm
Name of recruitment center - Persian: قشم
Full name of responsible person - English: Mehdi Hassaniazad
Full name of responsible person - Persian: مهدی حسنی ازاد
Street address - English: Hormozgan University of Medical Sciences, Bandar Abbas, Iran
Street address - Persian: ایران، بندر عباس، دانشگاه علوم پزشکی هرمزگان
City - English: Gheshm
City - Persian: قشم
Province: Hormozgan
Country: Iran (Islamic Republic of)
Postal code: 7916613885
Phone: +98 76 3371 0373
Fax:
Email: Mehdihassaniazad@gmail.com
Web page address:
Name of recruitment center - English: Gheshm Name of recruitment center - Persian: قشم Full name of responsible person - English: Mehdi Hassaniazad Full name of responsible person - Persian: مهدی حسنی ازاد Street address - English: Hormozgan University of Medical Sciences, Bandar Abbas, Iran Street address - Persian: ایران، بندر عباس، دانشگاه علوم پزشکی هرمزگان City - English: Gheshm City - Persian: قشم Province: Hormozgan Country: Iran (Islamic Republic of) Postal code: 7916613885 Phone: +98 76 3371 0373 Fax: Email: Mehdihassaniazad@gmail.com Web page address:
Protocol summary
Study aim
Determination of the effect of sofosbuvir/daclatasvir in COVID-19 patients
Design
A clinical trial with a, with parallel control group, double-blind, randomized, phase 3, and multicenter groups per 1000 patients.
Settings and conduct
The study is a double-blind clinical trial. The sample size is 1000. The patients are selected according to the eligibility criteria and are assigned to the intervention and control groups by a simple random method. participants, researchers, Care providers, Data analyzers, and outcome assessors are blind. The drugs used were similar in appearance.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age: >=18, One of the following signs: Fever ≥ 37.8°C at any one time, Dry cough, Severe fatigue, Dyspnea, CT appearance compatible with COVID, O2Sat 94% or less
Exclusion criteria:
Renal failure (eGFR < 30) Bradycardia (HR < 50), Taking amiodarone, Previous sofosbuvir use, Pregnancy/lactation, Multi-organ failure on admission (2 organs or more, excluding lung), Requiring intubation on admission, Significant arrhythmia in EKG, Allergy to sofosbuvir or daclatasvir, not consenting to the study
Intervention groups
Intervention group: Country Standard Pharmaceutical Protocol + SOF/DCV (400mg/60mg) one tablet daily for 10 days.
Control group: Country Standard Pharmaceutical Protocol + placebo one tablet daily for 10 days.
Main outcome variables
Recovery within 10 days since the start of taking medicine. Recovery defined as:
(No fever, No dyspnea, No or improved cough, No or improved fatigue, PO tolerance) for 24 hours
General information
Reason for update
Edit the Recruitment centers
Acronym
DISCOVER
IRCT registration information
IRCT registration number:IRCT20200624047908N1
Registration date:2020-07-05, 1399/04/15
Registration timing:prospective
Last update:2020-11-09, 1399/08/19
Update count:6
Registration date
2020-07-05, 1399/04/15
Registrant information
Name
gholamali eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5326 5363
Email address
gholamali.eslami1351@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-13, 1399/04/23
Expected recruitment end date
2020-09-08, 1399/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of sofosbuvir/daclatasvir in COVID-19 patients: a double-blind randomized clinical trial
Public title
Evaluation of the effect of sofosbuvir/daclatasvir in COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥18
One of the following signs: Fever ≥ 37.8°C at any one time, Dry cough, Severe fatigue, Dyspnea
CT appearance compatible with COVID
O2 Saturation 94% or less
Exclusion criteria:
Renal failure (eGFR < 30)
Bradycardia (HR < 50)
Taking amiodarone
Previous sofosbuvir use
Pregnancy/lactation
Multi-organ failure on admission (2 organs or more, excluding lung)
Requiring intubation on admission
Significant arrhythmia in EKG
Allergy to sofosbuvir or daclatasvir
Not consenting to the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
1000
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be a randomized, double-blind, phase 3, and multicenter clinical trials on 1000 patients. The randomization method is block randomization and the block size is 4. Sealed envelopes are used for the allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study participants, researchers, Care providers, Data analyzers, and outcome assessors are blind. The medicine and placebo are similar in appearance, so patients do not understand which group they are in.
Placebo
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
City
Abadan
Province
Khouzestan
Postal code
6313833177
Approval date
2020-06-21, 1399/04/01
Ethics committee reference number
IR.ABADANUMS.REC.1399.071
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
COVID-19
ICD-10 code description
U07.1
Primary outcomes
1
Description
Recovery within 10 days of starting the drug. Recovery means: (no fever, no shortness of breath, no cough or improved, no fatigue or improved, tolerated oral nutrition) for 24 hours.
Timepoint
Daily
Method of measurement
Clinical observation and examination
Secondary outcomes
1
Description
Recovery within 14 days from start of medication
Timepoint
Daily
Method of measurement
Clinical observation and examination
2
Description
Rate of survival
Timepoint
Daily
Method of measurement
census report
3
Description
Days admitted in hospital
Timepoint
Daily since hospitalization time
Method of measurement
Based on patient's file
4
Description
Days intubated/under ventilator
Timepoint
Daily
Method of measurement
observation
5
Description
Days admitted in ICU
Timepoint
Daily
Method of measurement
Based on patient's file
Intervention groups
1
Description
Intervention group: Country Standard Pharmaceutical Protocol + SOF/DCV (400mg/60mg) one tablet daily for 10 days
Category
Treatment - Drugs
2
Description
Control group: Country Standard Pharmaceutical Protocol + placebo one tablet daily for 10 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Abadan,Ayatollah Taleghani Hospital
Full name of responsible person
Gholamali Eslami
Street address
Ayatollah Taleghani Hospital , Station 12, in front of Azad University , Abadan, Khuzestan, Iran
City
Abadan
Province
Khouzestan
Postal code
-
Phone
+98 61 5336 1003
Email
gholamali.eslami1351@gmail.com
2
Recruitment center
Name of recruitment center
Abadan Oil Industry Imam Khomeini Hospital
Full name of responsible person
Gholamali Eslami
Street address
NO.671, Imam Khomeini Hospital, cyclin next to the refinery of Montazeri St, Abadan city, Khuzestan, IRAN
City
Abadan
Province
Khouzestan
Postal code
-
Phone
+98 61 5322 6811
Email
gholamali.eslami1351@gmail.com
3
Recruitment center
Name of recruitment center
Zabol
Full name of responsible person
Mehdi Afshari
Street address
Rajaee street, University of Medical Sciences
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 2176
Email
mahdiafshari99@gmail.com
4
Recruitment center
Name of recruitment center
Tehran
Full name of responsible person
Anahita Sadeghi
Street address
kargar st,Tehran University of Medical Sciences Shariati hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5300
Fax
Email
anahita825@gmail.com
5
Recruitment center
Name of recruitment center
Ghom
Full name of responsible person
Ahmad Hormaty
Street address
lavasany st, Ghom University of Medical Sciences
City
Ghom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2053
Fax
Email
hormatia@yahoo.com
6
Recruitment center
Name of recruitment center
Mazandaran
Full name of responsible person
Hamide Abaspor kasgary
Street address
Faculty of Pharmacy, Complex of the Great Prophet, Farahabad Road
City
Sary
Province
Mazandaran
Postal code
-
Phone
+98 11 3304 4000
Email
Dr.abbaspour1@yahoo.com
7
Recruitment center
Name of recruitment center
Iranshahr
Full name of responsible person
Fateme Azarkish
Street address
Baluch St. Deputy of Research and Technology, Sistan and Baluchestan Province, Iranshahr
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
۹۹۱۴۷۸۶۱۳۸
Phone
+98 54 3721 3328
Email
Azarkish2005@yahoo.com
8
Recruitment center
Name of recruitment center
Shiraz
Full name of responsible person
Zinab mehraby
Street address
Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences, Shiraz
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3230 5410
Email
mehrabizm4510@gmail.com
9
Recruitment center
Name of recruitment center
Bandar Abbas
Full name of responsible person
Elham Barahimi
Street address
Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3371 0373
Email
dr.e.barahimi@gmail.com
10
Recruitment center
Name of recruitment center
Gheshm
Full name of responsible person
Mehdi Hassaniazad
Street address
Hormozgan University of Medical Sciences, Bandar Abbas, Iran
City
Gheshm
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3371 0373
Email
Mehdihassaniazad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Gholamali Eslami
Street address
Deputy Minister of Educational Technology Research- Airport Square - Next to Ayatollah Jami International Airport , Abadan, Khuzestan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 5362
Email
gholamali.eslami1351@gmail.com
Grant name
ITPC-2020
Grant code / Reference number
ITPC-2020
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
International Treatment Preparedness coalition
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
UN agencies and international organizations
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Gholamali Eslami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Deputy Minister of Educational Technology Research- Airport Square - Next to Ayatollah Jami International Airport , Abadan, Khuzestan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 5362
Email
gholamali.eslami1351@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Gholamali Eslami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Deputy Minister of Educational Technology Research- Airport Square - Next to Ayatollah Jami International Airport , Abadan, Khuzestan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
006153265362
Email
gholamali.eslami1351@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Golamali Eslami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Deputy Minister of Educational Technology Research- Airport Square - Next to Ayatollah Jami International Airport , Abadan, Khuzestan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
006153265362
Email
golamali.eslami@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 can be shared after the participants in the study are unrecognizable.
When the data will become available and for how long
The data access period after publishing of the article
To whom data/document is available
The data in this study will be available for researchers working in 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 by main researcher permission.
From where data/document is obtainable
gholamali.eslami1351@gmail.com
What processes are involved for a request to access data/document
The researcher or pharmaceutical company can send their request to the academic email of project manager. After ensuring the accuracy of the submitted documents, the project manager will provide the requested information to the researcher or pharmaceutical company in of one week.