Protocol summary

Study aim
Determining of adding SOVODAK (sofosbuvir + daclatasvir) to the treatment protocol of COVID-19 outpatients: A Clinical Trial Study
Design
A clinical trial study will have a control group with a parallel design
Settings and conduct
This study will be performed in Miandrood Medical Clinic. One group of single-drug therapies included hydroxychloroquine tablets (200 mg twice daily for 7 days), the other group of two-drug therapies included a combination of hydroxychloroquine (200 mg twice daily for 7 days) and sudak tablets (60/400 mg). Grams once a day) will receive. Treatment will be with azithromycin capsules (500 mg for 6 days) with naproxen tablets (500 mg, 2 times a day for 7 days) and pantoprazole tablets 40 mg for both groups. Patients in both groups will be given training such as adequate rest, quarantine principles, and breathing capacity training.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with Quaid 19 confirmed by CT scan findings Exclusion criteria: َAmiodarone use and patients with specific underlying diseases such as renal failure
Intervention groups
The intervention group will receive hydroxychloroquine + SOVODAK and the comparison group will receive hydroxychloroquine.
Main outcome variables
1- Symptoms ending 2- Lymphopenic condition 3- CRP status 4- SPO2

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200403046926N1
Registration date: 2020-04-11, 1399/01/23
Registration timing: registered_while_recruiting

Last update: 2020-04-11, 1399/01/23
Update count: 0
Registration date
2020-04-11, 1399/01/23
Registrant information
Name
Fatemeh Roozbeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3310 8690
Email address
roozbeh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding SOVODAK (sofosbuvir+daclatasvir) to the treatment protocol of COVID-19 outpatients: A Clinical Trial Study
Public title
The effect of SOVODAK in the treatment of COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis by CT scan with clinical symptoms Consent to attend the study Lymphocyte count less than 1100 Positive CRP test
Exclusion criteria:
History of kidney failure Pregnancy Amiodarone consumer
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups by Block Randomization. The block size is 4 people and a random list will be created by the sealedenvelope site. To hide the drugs, they are placed in the required number in the envelope. Then, according to the random codes created, one or two envelopes will be placed in a larger envelope
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Miandrood Medical Center
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2020-04-01, 1399/01/13
Ethics committee reference number
IR.MAZUMS.REC.1399.017

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Symptoms ending
Timepoint
During the study
Method of measurement
Clinical examination

2

Description
Lymphopenic Status
Timepoint
Before the intervention and the seventh day
Method of measurement
Counting lymphocytes

3

Description
C-reactive protein Status
Timepoint
Before the intervention and the seventh day
Method of measurement
C-reactive protein serological test

4

Description
Saturation of Peripheral Oxygen
Timepoint
Before the intervention and the seventh day
Method of measurement
Pulseimetry

Secondary outcomes

1

Description
Need hospitalization
Timepoint
Depending on the situation
Method of measurement
Depending on the patient's condition

Intervention groups

1

Description
Intervention group: COVID-19 Patients receiving hydroxychloroquine + SOVODAK
Category
Treatment - Drugs

2

Description
Control group: COVID-19 Patients receiving hydroxychloroquine
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Miandrood Medical Center
Full name of responsible person
Fatemeh Roozbeh
Street address
Miandrood, Surak, Imam Khomeini St., Ashouri Medical Clinic
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3388 4579
Email
roozbeh@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Professor Majid Saeedi
Street address
Vice-Chancellor for Research, Moallem Sq.
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3448 4800
Email
msaeedi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Roozbeh
Position
Non-faculty physician
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Miandrood, Surak, Imam Khomeini St., Ashouri Medical Clinic
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3388 4579
Email
roozbeh@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Roozbeh
Position
Non-faculty physician
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Miandrood, Surak, Imam Khomeini St., Ashouri Medical Clinic
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3388 4579
Email
roozbeh@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Roozbeh
Position
Non-faculty physician
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Miandrood, Surak, Imam Khomeini St., Ashouri Medical Clinic
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3388 4579
Email
roozbeh@mazums.ac.ir

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
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
Not applicable
Title and more details about the data/document
The SPSS data file can be published
When the data will become available and for how long
After publication
To whom data/document is available
Scholars
Under which criteria data/document could be used
Use for review studies
From where data/document is obtainable
Correspondence E-mail
What processes are involved for a request to access data/document
Request via email
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