Determination of the efficacy of daclatasvir + sofosbuvir in patients with COVID-19
Design
Using a table of random numbers, they are divided into intervention and control groups. The volume of each group is 35 patients. The present study is a double-blind study.
Settings and conduct
Patients admitted to Razi Hospital in Ahvaz will be divided into two groups based on a table of random numbers.
Radiologists, treatment outcome evaluators, and statisticians will be unaware of assignments to groups, but patients and physicians will be aware of treatment groups.
Participants/Inclusion and exclusion criteria
Admission of hospitalized patients over 18 years of age; withdrawal of allergic reaction; pregnancy or lactation; any previous intervention; use of Amiodarone; need for mechanical ventilation and EGFR less than 50.
Intervention groups
In the intervention group, patients did not receive one Daclatasvir / Sofosbuvir tablet daily for 7 days in addition to the national recommendations, and the control group did not receive the drug.
Main outcome variables
The primary outcome is clinical improvement within 14 days of starting treatment, for which fever, respiration rate per minute, and oxygen saturation are determined daily. Criteria for clinical improvement include fever normalization (37.2 ° C), respiration rate (≤ 24 per minute), and oxygen saturation (94% in room air) and are stable for up to 24 hours.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200816048422N1
Registration date:2020-10-16, 1399/07/25
Registration timing:retrospective
Last update:2020-10-16, 1399/07/25
Update count:0
Registration date
2020-10-16, 1399/07/25
Registrant information
Name
Zahra Fakhrae
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 5937
Email address
z.fakhrae@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-25, 1399/04/05
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Daclatasvir+Sofosbuvir in patients with severe acute respiratory syndrome coronavirus (SARS-COVID-19)
Public title
Efficacy of Daclatasvir+Sofosbuvir in patients with severe acute respiratory syndrome coronavirus (SARS-COVID-19)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Respiratory rate more than 30 per minute Oxygen saturation less than 93%
Confirmation of pneumonia by diagnostic CT scan of the chest
Exclusion criteria:
Taking the drug Amiodarone
Kidney failure
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
According to the patients' block classification table, eleven blocks of six are divided into two groups a and b and the intervention is considered by the researcher of group a and the control group b.
According to the date of hospitalization, patients were divided into groups a and b, respectively, according to blockade. The concealment of the study is double-blind.
Blinding (investigator's opinion)
Double blinded
Blinding description
After providing explanations to patients by the researcher using a random drug process, the drug is prescribed in such a way that the researcher and the patient do not know about the drug and only the treating physician knows about the drug.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of jundishapoor ahwaz University of Medical Sciences
Street address
amaniye st razi hospital
City
ahwaz
Province
Khouzestan
Postal code
1494161965
Approval date
2020-06-20, 1399/03/31
Ethics committee reference number
IR.AJUMS.REC.1399.300
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID -19, virus identified
Primary outcomes
1
Description
Respiratory rate
Timepoint
14th day
Method of measurement
physical exam
2
Description
Arterial oxygen
Timepoint
7th day
Method of measurement
Physical examination
3
Description
Requires mechanical ventilation
Timepoint
7th day
Method of measurement
Physical examination
4
Description
Death
Timepoint
7th day
Method of measurement
Physical examination
5
Description
Chest changes
Timepoint
7th day
Method of measurement
Physical examination
Secondary outcomes
1
Description
Secondary consequences include the need for mechanical ventilation, chest changes (day 14 or earlier as determined by the physician), serious accidents, and mortality.
Timepoint
14th day
Method of measurement
Physical examination
Intervention groups
1
Description
Patients in the intervention group receive one Daclatasvir / Sofosbuvir 60/400 mg tablet (Danesh Pharmaceutical Development Company) daily for 7 days.
Category
Treatment - Drugs
2
Description
Control group: Received national protocol drugs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Dr Fatemeh Ahmadi
Street address
Razi hospital, Palestine Street
City
Ahwaz
Province
Khouzestan
Postal code
1965149416
Phone
+98 61 3333 5935
Email
z.fakhrae@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badawi
Street address
Jundishapur University of Medical Sciences, Golestan Town
City
Ahwaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3333 3311
Email
info@ajums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahwaz Jundishapur 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Zahrz Fakhrae
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Opposite number 61965 14941, in front of the Governorate, Palestine Street
City
Ahwaz
Province
Khouzestan
Postal code
61965 14941
Phone
+98 61 3333 5935
Email
z.fakhrae@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Ahmadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Opposite number 61965 14941, in front of the Governorate, Palestine Street
City
Ahwaz
Province
Khouzestan
Postal code
61965 14941
Phone
+98 61 3333 5935
Email
ahmadi-f@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Zahra Fakhraei
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Opposite number 61965 14941, in front of the Governorate, Palestine Street
City
Ahwaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 5935
Email
z.fakhrae@yahoo.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
No - There is not 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