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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Digestive Disease Research Institute
-
Proportion provided by this source
-
50
-
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
2
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Fannavaran Rojan Mohaghegh Daru
-
Proportion provided by this source
-
50
-
Public or private sector
-
Private
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Industry
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be 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
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable
-
Title and more details about the data/document
-
The study protocol, statistical analytic plan informed consent forms will be shared as supplementary material at the time of publication of results.
-
When the data will become available and for how long
-
At the time of publication
-
To whom data/document is available
-
Will be publically available as a supplement accompanying the published article.
-
Under which criteria data/document could be used
-
To interpret the findings of published study, and to use as a reference for future research
-
From where data/document is obtainable
-
On the website of journal that will publish the research
-
What processes are involved for a request to access data/document
-
They will be publically available.
-
Comments
-