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Protocol summary
Determination of the effect of sofosbovir / daclatasavir in COVID-19 patients
Determination of the effect of sofosbuvir/daclatasvir in COVID-19 patients
Determination of the effect of sofosbovir sofosbuvir/ daclatasavirdaclatasvir in COVID-19 patients
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 and multicenter on 1000 patients.
A clinical trial with a, with parallel control group, double-blind, randomized, phase 3, and multicenter groups per 1000 patients.
ClinicalA clinical trial with control groupa, with parallel groupscontrol group, double-blind, randomized, phase 3, and multicenter ongroups per 1000 patients.
The study is a double-blind clinical trial. The sample size is 1000. The samples are selected according to the entry criteria through the census and are assigned to the intervention and control groups by a simple random method.participants, researchers,Care provider, Data analyser and outcome assessor are blind. The drugs used were similar in appearance.
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.
The study is a double-blind clinical trial. The sample size is 1000. The samplespatients are selected according to the entryeligibility criteria through the census and are assigned to the intervention and control groups by a simple random method.participantsmethod. participants, researchers,Care providerresearchers, Care providers, Data analyseranalyzers, and outcome assessorassessors are blind. The drugs used were similar in appearance.
Inclusion criteria:
Age: >=18, (including one of Fever ≥ 37.8°C at any one time, Dry cough, Severe fatigue, Dyspnea), CT involvement compatible with COVID-19, 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
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
Inclusion criteria: Age: >=18, (including oneOne of the following signs: Fever ≥ 37.8°C at any one time, Dry cough, Severe fatigue, Dyspnea), CT involvementappearance compatible with COVID-19, 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, Notnot consenting to the study
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.
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.
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.
Recovery within 10 days from start of medication. Recovery defined as:
(O2sat ≥95% or ≥5% improvement from baseline, No fever, No dyspnea, No or improved cough, No or improved fatigue, PO tolerance ) for 24 hours
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
Recovery within 10 days fromsince the start of medicationtaking medicine. Recovery defined as: (O2sat ≥95% or ≥5% improvement from baseline, No fever, No dyspnea, No or improved cough, No or improved fatigue, PO tolerance) for 24 hours
بهبودی در طی 10 روز از شروع دارو. بهبودی به صورت زیر تعریف شده است:
(O2sat ≥95% و یا بهبود ≥5% نسبت به میزان اولیه ، بدون تب، بدون تنگی نفس ، عدم سرفه یا بهبود یافته، عدم خستگی یا بهبود یافته، تحمل تغذیه از راه دهان ) به مدت 24 ساعت
بهبودی در طی 10 روز از شروع دارو. بهبودی به صورت زیر تعریف شده است:
( بدون تب، بدون تنگی نفس ، عدم سرفه یا بهبود یافته، عدم خستگی یا بهبود یافته، تحمل تغذیه از راه دهان ) به مدت 24 ساعت
بهبودی در طی 10 روز از شروع دارو. بهبودی به صورت زیر تعریف شده است: (O2sat ≥95% و یا بهبود ≥5% نسبت به میزان اولیه ، بدون تب، بدون تنگی نفس ، عدم سرفه یا بهبود یافته، عدم خستگی یا بهبود یافته، تحمل تغذیه از راه دهان ) به مدت 24 ساعت
General information
Update study inclusion criteria
Editing Patient Centers
Update study inclusion criteriaEditing Patient Centers
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Evaluation of the effect of sofosbuvir/daclatasvir in COVID-19 patients: A randomized double-blind clinical trial
Evaluation of the effect of sofosbuvir/daclatasvir in COVID-19 patients: a double-blind randomized clinical trial
Evaluation of the effect of sofosbuvir/daclatasvir in COVID-19 patients: A randomizeda double-blind randomized clinical trial
Age: >=18
including one of Fever ≥ 37.8°C at any one time, Dry cough, Severe fatigue, Dyspnea
CT involvement compatible with COVID
O2Sat 94% or less
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
Age: >= ≥18 including oneOne of the following signs: Fever ≥ 37.8°C at any one time, Dry cough, Severe fatigue, Dyspnea CT involvementappearance compatible with COVID O2SatO2 Saturation 94% or less
سن >=18
شامل: تب بالای 37.8 درجه سانتی گراد در هر زمان ، سرفه خشک ، خستگی شدید ، تنگی نفس
درگیری CT با COVID-19
O2Sat 94% یا کمتر
سن ≥ 18
علائم شامل یکی از موارد: تب بالای 37.8 درجه سانتی گراد در هر زمان ، سرفه خشک ، خستگی شدید ، تنگی نفس
درگیری CT با COVID-19
O2Sat 94% یا کمتر
سن >=≥ 18 علائم شامل یکی از موارد: تب بالای 37.8 درجه سانتی گراد در هر زمان ، سرفه خشک ، خستگی شدید ، تنگی نفس درگیری CT با COVID-19 O2Sat 94% یا کمتر
This study will be a randomized, double-blind, phase 3 clinical trials and multicenter on 1000 patients. Randomization method is block randomization and block size was 4. Sealed envelopes were used for allocation concealment.
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.
This study will be a randomized, double-blind, phase 3, and multicenter clinical trials and multicenter on 1000 patients. RandomizationThe randomization method is block randomization and the block size wasis 4. Sealed envelopes wereare used for the allocation concealment.
In this study participants, researchers,Care provider, Data analyser and outcome assessor are blind. The drugs used were similar in appearance, So patients do not understand which group they are in. Sealed envelopes were used for allocation concealment.
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.
In this study participants, researchers,Care providerresearchers, Care providers, Data analyseranalyzers, and outcome assessorassessors are blind. The drugs used weremedicine and placebo are similar in appearance, Soso patients do not understand which group they are in. Sealed envelopes were used for allocation concealment.
شرکت کنندگان، محقق، مراقب بالینی، آنالیز کننده داده و ارزیابی کننده پیامد در این مطالعه کور می باشند. داروی مورد استفاده از نظر شکل ظاهری مشابه می باشند، بنابراین بیماران
متوجه نمی شوند که در کدام گروه قرار دارند. برای پنهان سازی زنجیره تصادفی شده از روش پاکت های در بسته استفاده شد.
شرکت کنندگان، محقق، مراقب بالینی، آنالیز کننده داده و ارزیابی کننده پیامد در این مطالعه کور می باشند. داروی مورد استفاده از نظر شکل ظاهری مشابه می باشند، بنابراین بیماران
متوجه نمی شوند که در کدام گروه قرار دارند. برای پنهان سازی زنجیره تصادفی شده از روش
پاکت های در بسته استفاده شد.
شرکت کنندگان، محقق، مراقب بالینی، آنالیز کننده داده و ارزیابی کننده پیامد در این مطالعه کور می باشند. داروی مورد استفاده از نظر شکل ظاهری مشابه می باشند، بنابراین بیماران متوجه نمی شوند که در کدام گروه قرار دارند. برای پنهان سازی زنجیره تصادفی شده از روش پاکت های در بسته استفاده شد.
Primary outcomes
#1
Recovery within 10 days from start of medication. Recovery defined as:(O2sat ≥95% or ≥5% improvement from baseline, No fever, No dyspnea, No or improved cough, No or improved fatigue, PO tolerance ) for 24 hours
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.
Recovery within 10 days from start of medicationstarting the drug. Recovery defined asmeans:(O2sat ≥95% or ≥5% improvement from baseline, Nono fever, No dyspneano shortness of breath, Nono cough or improved cough, Nono fatigue or improved fatigue, PO tolerance tolerated oral nutrition) for 24 hours.
بهبودی در طی 10 روز از شروع دارو. بهبودی به معنای : (بهبود O2sat ≥ 95 or یا 5 ≥ بهبود از میزان اولیه ، بدون تب ، بدون تنگی نفس ، عدم سرفه یا بهبود یافته ، عدم خستگی یا بهبود یافته ، تحمل تغذیه از راه دهان) به مدت 24 ساعت
بهبودی در طی 10 روز از شروع دارو. بهبودی به معنای : ( بدون تب ، بدون تنگی نفس ، عدم سرفه یا بهبود یافته ، عدم خستگی یا بهبود یافته ، تحمل تغذیه از راه دهان) به مدت 24 ساعت
بهبودی در طی 10 روز از شروع دارو. بهبودی به معنای : (بهبود O2sat ≥ 95 or یا 5 ≥ بهبود از میزان اولیه ، بدون تب ، بدون تنگی نفس ، عدم سرفه یا بهبود یافته ، عدم خستگی یا بهبود یافته ، تحمل تغذیه از راه دهان) به مدت 24 ساعت
Recruitment centers
#1
Name of recruitment center - English: Abadan, Mazandaran, Gilan, Tehran, Qom, Birjand, Fasa, Shiraz and Zabol
Name of recruitment center - Persian: آبادان، مازندران، گیلان، تهران، قم، بیرجند، فسا، شیراز و زابل
Full name of responsible person - English: Gholamali Eslami
Full name of responsible person - Persian: غلامعلی اسلامی
Street address - English: Ayatollah Taleghani Hospital , Station 12, in front of Azad University , Abadan, Khuzestan, Iran
Street address - Persian: خوزستان ، شهرستان آبادان ، روبه رو دانشگاه آزاد ، ایستگاه ۱۲ ، بیمارستان آیت الله طالقانی
City - English: Abadan
City - Persian: آبادان
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: -
Phone: +98 61 5336 1003
Fax:
Email: gholamali.eslami1351@gmail.com
Web page address:
Name of recruitment center - English: Abadan, Mazandaran, Gilan, Tehran, Qom, Iranshahr. Birjand, Fasa, Shiraz, Bandar abbas, Qeshm and Za
Name of recruitment center - Persian: آبادان، مازندران، گیلان، تهران، قم، ایرانشهر، بیرجند، فسا، شیراز ، بندر عباس ، قشم و زابل
Full name of responsible person - English: Gholamali Eslami
Full name of responsible person - Persian: غلامعلی اسلامی
Street address - English: Ayatollah Taleghani Hospital , Station 12, in front of Azad University , Abadan, Khuzestan, Iran
Street address - Persian: خوزستان ، شهرستان آبادان ، روبه رو دانشگاه آزاد ، ایستگاه ۱۲ ، بیمارستان آیت الله طالقانی
City - English: Abadan
City - Persian: آبادان
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: -
Phone: +98 61 5336 1003
Fax:
Email: gholamali.eslami1351@gmail.com
Web page address:
Name of recruitment center - English: Abadan, Mazandaran, Gilan, Tehran, Qom, Iranshahr. Birjand, Fasa, Shiraz, Bandar abbas, Qeshm and ZabolZa Name of recruitment center - Persian: آبادان، مازندران، گیلان، تهران، قم، ایرانشهر، بیرجند، فسا، شیراز ، بندر عباس ، قشم و زابل Full name of responsible person - English: Gholamali Eslami Full name of responsible person - Persian: غلامعلی اسلامی Street address - English: Ayatollah Taleghani Hospital , Station 12, in front of Azad University , Abadan, Khuzestan, Iran Street address - Persian: خوزستان ، شهرستان آبادان ، روبه رو دانشگاه آزاد ، ایستگاه ۱۲ ، بیمارستان آیت الله طالقانی City - English: Abadan City - Persian: آبادان Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: - Phone: +98 61 5336 1003 Fax: Email: gholamali.eslami1351@gmail.com Web page address:
#2
Name of recruitment center - English: Zabol
Name of recruitment center - Persian: زابل
Full name of responsible person - English: Mehdi Afshari
Full name of responsible person - Persian: مهدی افشاری
Street address - English: Zabol University of Medical Sciences, Rajaee street
Street address - Persian: دانشگاه علوم پزشکی زابل ، خیابان رجایی
City - English: Zabol
City - Persian: زابل
Province: Sistan-va-Balouchestan
Country: Iran (Islamic Republic of)
Postal code: 9861615881
Phone: +98 54 3223 2176
Fax:
Email: mahdiafshari99@gmail.com
Web page address:
Name of recruitment center - English: Zabol Name of recruitment center - Persian: زابل Full name of responsible person - English: Mehdi Afshari Full name of responsible person - Persian: مهدی افشاری Street address - English: Zabol University of Medical Sciences, Rajaee street Street address - Persian: دانشگاه علوم پزشکی زابل ، خیابان رجایی City - English: Zabol City - Persian: زابل Province: Sistan-va-Balouchestan Country: Iran (Islamic Republic of) Postal code: 9861615881 Phone: +98 54 3223 2176 Fax: Email: mahdiafshari99@gmail.com Web page address:
#3
Name of recruitment center - English: Tehran
Name of recruitment center - Persian: تهران
Full name of responsible person - English: Anahita Sadeghi
Full name of responsible person - Persian: آناهیتا صادقی
Street address - English: Tehran University of Medical Sciences Shariati hospital, kargar st
Street address - Persian: دانشگاه علوم پزشکی تهران ، بیمارستان شریعتی، خیابان کارگر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713135
Phone: +98 21 8241 5300
Fax:
Email: anahita825@gmail.com
Web page address:
Name of recruitment center - English: Tehran Name of recruitment center - Persian: تهران Full name of responsible person - English: Anahita Sadeghi Full name of responsible person - Persian: آناهیتا صادقی Street address - English: Tehran University of Medical Sciences Shariati hospital, kargar st Street address - Persian: دانشگاه علوم پزشکی تهران ، بیمارستان شریعتی، خیابان کارگر City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411713135 Phone: +98 21 8241 5300 Fax: Email: anahita825@gmail.com Web page address:
#4
Name of recruitment center - English: Ghom
Name of recruitment center - Persian: قم
Full name of responsible person - English: Ahmad Hormaty
Full name of responsible person - Persian: احمد حرمتی
Street address - English: Ghom University of Medical Sciences , lavasany st
Street address - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی درمانی قم ، خیابان شهید لواسانی (ساحلی)
City - English: Ghom
City - Persian: قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 3713649373
Phone: +98 25 3612 2053
Fax:
Email: hormatia@yahoo.com
Web page address:
Name of recruitment center - English: Ghom Name of recruitment center - Persian: قم Full name of responsible person - English: Ahmad Hormaty Full name of responsible person - Persian: احمد حرمتی Street address - English: Ghom University of Medical Sciences , lavasany st Street address - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی درمانی قم ، خیابان شهید لواسانی (ساحلی) City - English: Ghom City - Persian: قم Province: Ghoum Country: Iran (Islamic Republic of) Postal code: 3713649373 Phone: +98 25 3612 2053 Fax: Email: hormatia@yahoo.com Web page address:
#5
Name of recruitment center - English: Mazandaran
Name of recruitment center - Persian: مازندران
Full name of responsible person - English: Hamide Abaspor kasgary
Full name of responsible person - Persian: حمیده عباسپور کاسگری
Street address - English: Farahabad Road, Complex of the Great Prophet, Faculty of Pharmacy
Street address - Persian: جاده فرح آباد ،مجتمع پیامبر اعظم ،دانشکده داروسازی
City - English: Sary
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: -
Phone: +98 11 3304 4000
Fax:
Email: Dr.abbaspour1@yahoo.com
Web page address:
Name of recruitment center - English: Mazandaran Name of recruitment center - Persian: مازندران Full name of responsible person - English: Hamide Abaspor kasgary Full name of responsible person - Persian: حمیده عباسپور کاسگری Street address - English: Farahabad Road, Complex of the Great Prophet, Faculty of Pharmacy Street address - Persian: جاده فرح آباد ،مجتمع پیامبر اعظم ،دانشکده داروسازی City - English: Sary City - Persian: ساری Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: - Phone: +98 11 3304 4000 Fax: Email: Dr.abbaspour1@yahoo.com Web page address:
Sharing plan
-All data can be shared after the participants in the study are unrecognizable.
All data can be shared after the participants in the study are unrecognizable.
-All data can be shared after the participants in the study are unrecognizable.
The data access period after printing the article
The data access period after publishing of the article
The data access period after printingpublishing of the article
The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration.
The data in this study will be available for researchers working in academic and scientific institutions, as well as the Food and Drug Administration.
The data in this study will be available tofor researchers working atin academic and scientific institutions, as well as the Food and Drug Administration.
Any analysis can be done with the consent of the main researcher.
Any analysis can be done by main researcher permission.
Any analysis can be done with the consent of theby main researcher permission.
The researcher or pharmaceutical company can send their request to the academic email after sending the documents to confirm their original identity.The project manager will then provide the requested information to the researcher or pharmaceutical company after ensuring the accuracy of the submitted documents after a period of one week.
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.
The researcher or pharmaceutical company can send their request to the academic email after sendingof project manager. After ensuring the accuracy of the submitted documents to confirm their original identity.The, the project manager will then provide the requested information to the researcher or pharmaceutical company after ensuring the accuracy of the submitted documents after a periodin of one week.
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
Editing Patient Centers
Acronym
DISCOVER
IRCT registration information
IRCT registration number:IRCT20200624047908N1
Registration date:2020-07-05, 1399/04/15
Registration timing:prospective
Last update:2020-09-25, 1399/07/04
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, Mazandaran, Gilan, Tehran, Qom, Iranshahr. Birjand, Fasa, Shiraz, Bandar abbas, Qeshm and Za
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
Zabol University of Medical Sciences, Rajaee street
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
Tehran University of Medical Sciences Shariati hospital, kargar st
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5300
Email
anahita825@gmail.com
5
Recruitment center
Name of recruitment center
Ghom
Full name of responsible person
Ahmad Hormaty
Street address
Ghom University of Medical Sciences , lavasany st
City
Ghom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2053
Email
hormatia@yahoo.com
6
Recruitment center
Name of recruitment center
Mazandaran
Full name of responsible person
Hamide Abaspor kasgary
Street address
Farahabad Road, Complex of the Great Prophet, Faculty of Pharmacy
City
Sary
Province
Mazandaran
Postal code
-
Phone
+98 11 3304 4000
Email
Dr.abbaspour1@yahoo.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
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
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.