Determination of the effect of silymarin on rhodsivider-induced hepatotoxicity in patients with COVID-19 admitted to Shahrekord hospitals
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 70 patients. Excel software rand function was used for randomization.
Settings and conduct
This research project is a quasi-experimental study in which 70 people with inclusion criteria in this study are randomly divided into two intervention groups of 35 people and control of 35 people. The recent study is double blind randomized clinical trial and will be performed in Hajar Hospital in Shahrekord, Iran.
Liver samples are measured before entering the study on a daily basis and also on the seventh day of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with positive PCR test who have been treated with RamedSavier; SpO2 blood oxygen saturation level less than 93% in room air or patients in need of supportive oxygen or mechanical ventilation; patients with pulmonary infiltration in radiological studies; absence of underlying liver disease such as liver cirrhosis and viral hepatitis, etc. according to the history taken.
5. Liver enzymes less than 5 times normal
Intervention groups
The first group of Remdesivir + Livergol 140 mg 3 times a day for 1 week; the second group received Remdesivir + placebo 3 times a day for 1 week.
Main outcome variables
Main outcome variables include ALT; AST; ALP; BILL total; BILL direct.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201227049854N1
Registration date:2021-07-11, 1400/04/20
Registration timing:registered_while_recruiting
Last update:2021-07-11, 1400/04/20
Update count:0
Registration date
2021-07-11, 1400/04/20
Registrant information
Name
Saeed Badiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3264 4568
Email address
saeedbadiei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Silymarin on hepatotoxicity induced by Remdesivir in patients with COVID-19 admitted to Shahrekord hospitals
Public title
Evaluation of the effect of silymarin on hepatotoxicity induced by Remdesivir
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with positive covid19 PCR test who have been treated with Remdesivir
Spo2<93%
Patient with lung infiltration
Absence of underlying liver disease
Liver enzymes less than 5 times normal
Exclusion criteria:
Increased liver enzymes more than 5 times normal
Patient dissatisfaction
Pregnant or lactating patients
Patients with glomerular filtration less than 50 mg / min
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into one of three groups: A (patient 1 to 35), group B (36 to 70), and group C (71 to 105).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, residents, patients, and statistical counselors are kept blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani St.
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2020-12-23, 1399/10/03
Ethics committee reference number
IR.SKUMS.REC.1399.198
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
Direct Billirubin
Timepoint
Measurement of liver enzymes on the first and seventh days of the study
Method of measurement
Measurement of liver enzymes by BT 3500 device
2
Description
Total Billirubin
Timepoint
Measurement of liver enzymes on the first and seventh days of the study
Method of measurement
Measurement of liver enzymes by BT 3500 device
3
Description
Aspartate Aminotransferase
Timepoint
Measurement of liver enzymes on the first and seventh days of the study
Method of measurement
Measurement of liver enzymes by BT 3500 device
4
Description
Alanine Aminotransferase
Timepoint
Measurement of liver enzymes on the first and seventh days of the study
Method of measurement
Measurement of liver enzymes by BT 3500 device
5
Description
Alkaline Phosphatase
Timepoint
Measurement of liver enzymes on the first and seventh days of the study
Method of measurement
Measurement of liver enzymes by BT 3500 device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Remdesivir + Livergel 140 mg 3 times a day for 1 week.
Category
Treatment - Drugs
2
Description
Control group: Remdesivir + placebo 3 times a day for 1 week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital in Shahrekord
Full name of responsible person
Zahra Habibi
Street address
Hajar Hospital, Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Fax
+98 38 3224 3715
Email
Hajar-Hospital@skums.ac.ir
Web page address
https://hajarhp.skums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Kashani St. Headquarters of Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
vcrt@skums.ac.ir
Web page address
https://research.skums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Habibi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hajar Hospital, Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
Hajar-Hospital@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Habibi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hajar Hospital, Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
Hajar-Hospital@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Saeed Badiei
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Hajar Hospital, Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
saeedbadiei@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Dr. Zahra Habibi
Under which criteria data/document could be used
The documents can be used after printing the results
From where data/document is obtainable
The data can be used by referring to the e-mail address
What processes are involved for a request to access data/document
Access period starts 6 months after the results are published