A prospective randomized controlled trial comparing Sovodak (Sofosbuvir plus Daclatasvir) in participants with moderate to severe Coronavirus disease (COVID-19) compared to standard of care treatment
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
This is a parallel 2-arm randomized, controlled, double-blind, single center study. 70 patients are enrolled and followed for 14 days.
This is a parallel 2-arm randomized, controlled, double-blind, multi center study. 70 patients are enrolled and followed for 14 days.
This is a parallel 2-arm randomized, controlled, double-blind, singlemulti center study. 70 patients are enrolled and followed for 14 days.
این پروژه‌ی تحقیقاتی یک کارآزمایی بالینی تصادفی، كنترل‌شده، دوسویه کور، دارای دو بازوی موازی، تک مرکزی می باشد. 70 بیمار وارد مطالعه شده و به مدت 14 روز پیگیری خواهند شد.
این پروژه‌ی تحقیقاتی یک کارآزمایی بالینی تصادفی، كنترل‌شده، دوسویه کور، دارای دو بازوی موازی، چند مرکزی می باشد. 70 بیمار وارد مطالعه شده و به مدت 14 روز پیگیری خواهند شد.
این پروژه‌ی تحقیقاتی یک کارآزمایی بالینی تصادفی، كنترل‌شده، دوسویه کور، دارای دو بازوی موازی، تکچند مرکزی می باشد. 70 بیمار وارد مطالعه شده و به مدت 14 روز پیگیری خواهند شد.
General information
empty
70
70
empty
2020-03-26, 1399/01/07
2020-03-26 00:00:00
empty
2020-04-26, 1399/02/07
2020-04-26 00:00:00
empty
2020-05-18, 1399/02/29
2020-05-18 00:00:00
Adding other hospitals for recruiting patients
The trial was completed.
Adding other hospitals for recruiting patientsThe trial was completed.
اضافه کردن سایر بیمارستان ها برای بیمارگیری
تریال به اتمام رسید
اضافه کردن سایر بیمارستان ها برای بیمارگیریتریال به اتمام رسید
Recruitment centers
#1
Name of recruitment center - English: Sayad Shirazi Hospital
Name of recruitment center - Persian: بیمارستان صیاد شیرازی
Full name of responsible person - English: Alireza Norouzi
Full name of responsible person - Persian: علیرضا نوروزی
Street address - English: گرگان - بلوار شهید صیاد شیرازی
Street address - Persian: Gorgan - Shahid Sayyad Shirazi Boulevard
City - English: Gorgan
City - Persian: گرگان
Province: Golestan
Country: Iran (Islamic Republic of)
Postal code: 4917867439
Phone: +98 17 3226 1175
Fax:
Email: norouzi54@gmail.com
Web page address:
Name of recruitment center - English: Sayad Shirazi Hospital
Name of recruitment center - Persian: بیمارستان صیاد شیرازی
Full name of responsible person - English: Alireza Norouzi
Full name of responsible person - Persian: علیرضا نوروزی
Street address - English: Shahid Sayyad Shirazi Boulevard
Street address - Persian: گرگان - بلوار شهید صیاد شیرازی
City - English: Gorgan
City - Persian: گرگان
Province: Golestan
Country: Iran (Islamic Republic of)
Postal code: 4917867439
Phone: +98 17 3226 1175
Fax:
Email: norouzi54@gmail.com
Web page address:
Name of recruitment center - English: Sayad Shirazi Hospital Name of recruitment center - Persian: بیمارستان صیاد شیرازی Full name of responsible person - English: Alireza Norouzi Full name of responsible person - Persian: علیرضا نوروزی Street address - English: Shahid Sayyad Shirazi Boulevard Street address - Persian: گرگان - بلوار شهید صیاد شیرازی Street address - Persian: Gorgan - Shahid Sayyad Shirazi Boulevard City - English: Gorgan City - Persian: گرگان Province: Golestan Country: Iran (Islamic Republic of) Postal code: 4917867439 Phone: +98 17 3226 1175 Fax: Email: norouzi54@gmail.com Web page address:
Protocol summary
Study aim
To evaluate whether Sovodak (Sofosbuvir plus Daclatasvir) increases significant clinical improvement as compared to standard of care in hospitalized patients with moderate to severe COVID-19.
Design
This is a parallel 2-arm randomized, controlled, double-blind, multi center study. 70 patients are enrolled and followed for 14 days.
Settings and conduct
The study will be conducted in Shariati hospital (Tehran), Baharloo (Tehran), Sina (Tehran), Sayyad Shirazi (Gorgan) by investigators of digestive disease research institute (TUMS).
Radiologists, physicians who assess outcomes and the statistician analyzing the data will be blinded but the patients and physicians who treat patients will know the assigned treatment group.
Participants/Inclusion and exclusion criteria
All moderate to severe COVID-19 infected patients admitted to Shariati hospital (Tehran), Baharloo (Tehran), Sina (Tehran), Sayyad Shirazi (Gorgan)
Inclusion criteria: age ≥ 18y; hospitalized patients with: Fever (Oral temperature ≥ 37.8 ℃) and at least one of Respiratory rate >24/min / O2Sat<94% or the Pa02/Fi02 ratio <300mgHg; PCR confirmed; diagnostic chest CT scan.
Exclusion criteria: known allergic reaction to intervention drug, pregnant or breastfeeding, any prior experimental treatment for COVID-19, heart rate<60/min, taking Amiodarone, evidence of multiorgan failure, requiring mechanical ventilation at screening, eGFR< 50 mL/min
Intervention groups
70 eligible patients with moderate to severe COVID-19 in a 1:1 ratio:
• Standard of care treatment
• Sovodak tablet (Sofosbuvir 400mg/Daclatasvir 60mg) + Standard of care treatment
Main outcome variables
Clinical recovery (composite) within 14 days from initiation of study treatment until normalization of fever (≤37.2 °C oral), respiratory rate (≤24/minute on room air), and oxygen saturation (≥94% on room air), sustained for at least 24 hours.
General information
Reason for update
The trial was completed.
Acronym
IRCT registration information
IRCT registration number:IRCT20200128046294N2
Registration date:2020-03-14, 1398/12/24
Registration timing:prospective
Last update:2020-06-01, 1399/03/12
Update count:4
Registration date
2020-03-14, 1398/12/24
Registrant information
Name
Anahita Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8241 5104
Email address
a-sadeghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-26, 1399/01/07
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
2020-03-26, 1399/01/07
Actual recruitment end date
2020-04-26, 1399/02/07
Trial completion date
2020-05-18, 1399/02/29
Scientific title
A prospective randomized controlled trial comparing Sovodak (Sofosbuvir plus Daclatasvir) in participants with moderate to severe Coronavirus disease (COVID-19) compared to standard of care treatment
Public title
Study to Evaluate the Safety and Efficacy of Sofosbuvir/Daclatasvir in Participants with Moderate to Severe Coronavirus Disease (COVID-19)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both genders
Age ≥18 years at time of signing Informed Consent Form
Willing and able to provide written informed consent prior to performing study to any assigned treatment arm
Must agree not to enroll in another study of an investigational agent prior to completion of study
Will be admitted to Shariati hospital (Tehran), Baharloo (Tehran), Sina (Tehran), Sayyad Shirazi (Gorgan) and not transferred to another hospital
Laboratory (RT-PCR) confirmed infection with 2019-nCoV
Lung involvement confirmed with chest CT scan
Hospitalized patients with: Fever (Oral temperature ≥ 37.8 ℃) and at least one of Respiratory rate >24/min / O2Sat<94% or the Pa02/Fi02 ratio <300mgHg
≤8 days since illness onset
Exclusion criteria:
Known allergic reaction to Sofosbuvir or Daclatasvir
Pregnant or breastfeeding, or positive pregnancy test
Receipt of any experimental treatment for COVID-19 prior to the time of the screening evaluation
Heart rate < 60/min
Taking Amiodarone
Evidence of multiorgan failure
Requiring mechanical ventilation at screening
eGFR< 50 mL/min
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized in a 1:1 ratio into one of the treatment groups and standard of care group using computer generated randomization plan. The date and time of randomization will be recorded. Allocation concealment will be done with the sealed envelope method.
Blinding (investigator's opinion)
Single blinded
Blinding description
The treatment assignment will remain unknown until the patient is randomized. Physicians who treat patients and the patients will not be blinded. Radiologists, physicians who assess outcomes and the statistician analyzing the data all will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Research Ethics Committee, Vice-Chancellor in Research Affairs- Tehran University of M
Street address
Central Building of Tehran University of Medical Sciences: No. 226, Qods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2020-03-11, 1398/12/21
Ethics committee reference number
IR.TUMS.VCR.REC.1398.1035
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Clinical recovery (composite) within 14 days from initiation of study treatment until normalization of fever (≤37.2 °C oral), respiratory rate (≤24/minute on room air), and oxygen saturation (≥94% on room air), sustained for at least 24 hours.
Timepoint
daily up to 14 days after starting the trial
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Requirement for mechanical ventilation
Timepoint
daily up to day 14
Method of measurement
Clinical evaluation
2
Description
Radiological changes
Timepoint
day 14 or sooner at the discretion of the physician
Method of measurement
Chest CT scan
3
Description
Serious adverse events
Timepoint
Any time during study up to day 14
Method of measurement
Clinical evaluation
4
Description
All-cause mortality
Timepoint
Any time during study up to day 14
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Control group: Standard of care treatment according to the national guidelines for the treatment of COVID-19
Category
Treatment - Drugs
2
Description
Intervention group: Sovodak, Company: Rojan, Daily single oral tablet containing 400mg of Sofosbovir and 60mg of Daclatasvir plus Standard of care treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr Anahita Sadeghi
Street address
Shariati Hospital, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5000
Fax
+98 21 8241 5400
Email
a-sadeghi@tums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mahnaz Montazeri
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini Ave, Tehran, Iran