Evaluating the safety of sofosbuvir 800mg /Daclatasvir 120 mg in outpatient with COVID 19
Design
Study group: one arm open-label study with only one intervention group consists of 50 patients followed for 10 days
Settings and conduct
Patients will be recruited from the outpatient's clinic of Shariati hospital. Eligible patients will be included in the study and will receive orally the tablet of Daclatasvir 60 mg/sofosbuvir 400 mg twice per day (total of Daclatasvir 120 mg/sofosbuvir 800 mg)
Participants/Inclusion and exclusion criteria
Participants: Both sexes age higher than 18 years old
Inclusion criteria: Diagnosis of COVID 19 Patients that do not need to be admitted in hospital
Exclusion criteria: Patients without consent form, Patients that can not come for follow-up, Pregnancy or breastfeeding, Renal insufficiency with eGFR less than 30, or serum creatinin higher than 2.5 mg/dl in male and 2 mg/dl in female or need dialysis, Heart rate less than 50/ min, Hepatitis B infection, Amiodarone and or Warfarin consumption
Any related or non related adverse events occurred during study period
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200128046294N3
Registration date:2020-10-22, 1399/08/01
Registration timing:prospective
Last update:2020-10-22, 1399/08/01
Update count:0
Registration date
2020-10-22, 1399/08/01
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
2020-10-24, 1399/08/03
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety study of Sofosbuvir 800mg and Daclatasvir 120mg in adult outpatients with COVID-19
Public title
Safety of Sofosbuvir /Daclatasvir in outpatients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both sexes
Age higher than 18 years old
Diagnosis of COVID 19
Patients that do not need to be admitted in hospital
Exclusion criteria:
Patients without consent form
Patients that can not come for follow-up
Pregnancy , breast feeding
Renal insufficiency with eGFR less than 30 , or serum creatinin higher than 2.5 mg/dl in male and 2 mg/dl in female
Heart rate less than 50/ min
Hepatitis B infection
Amiodarone and /or Warfarin consumption
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Digestive Disease Research Institute - Tehran University of Medical Sciences
Street address
Digestive Disease Research Institute, Shariati Hospital, Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2020-10-13, 1399/07/22
Ethics committee reference number
IR.TUMS.DDRI.REC.1399.024
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.2
ICD-10 code description
Clinical or epidemiological diagnosis of COVID-19 where laboratory confirmation is inconclusive or not available.
Primary outcomes
1
Description
Related or non -related adverse events
Timepoint
Before intervention and 48 hours after the end of the study (day 12 of study)
Method of measurement
Daily follow-up
Secondary outcomes
1
Description
Time to clinical recovery
Timepoint
Before intervention and 48 hours after the end of the study (day 12 of study)
Method of measurement
Clinical Follow-up
2
Description
Hospitalization
Timepoint
Before intervention and 48 hours after the end of the study (day 12 of study)
Method of measurement
Clinical follow-up
3
Description
Death
Timepoint
Before intervention and 48 hours after the end of the study (day 12 of study)
Method of measurement
Clinical follow-up
Intervention groups
1
Description
Intervention group: receiving Sofosbuvir 800mg and Daclatasvir 120mg (two drugs combination of Sofosbuvir 400mg and Daclatasvir 60mg, two tablets per day, Sovodak) produced by :Fanavaran Rojan Mohaghegh Daru Co., Tehran, Iran. for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Neda Alijani
Street address
Shariati Hospital, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
dna1461@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Merat
Street address
Shariati hospital, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5000
Email
shahin.merat@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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Anahita Sadeghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shariati hospital, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5176
Email
anahita825@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Anahita Sadeghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shariati hospital, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5176
Email
anahita825@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Anahita Sadeghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shariati hospital, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5176
Email
anahita825@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available