Comparative assessment of the efficacy and safety of addon treatment with “Sofosbuvir-Daclatasvir”, “Lithium”,and “Trifluoprazine” to “standard of care in three groups of patients with COVID-19
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Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Babak Sayad
Full name of responsible person - Persian: دکتر بابک صیاد
Position - English: Faculty member of Kermanshah University of Medical Sciences
Position - Persian: عضو هیات علمی دانشگاه علوم پزشکی کرمانشاه
Latest degree: specialist
Area of specialty/work: 62
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Emam Reza Hospital, Parastar Boulevard
Street address - Persian: بلوار پرستار، بيمارستان امام رضا
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6715847141
Phone: +98 83 3427 6306
Mobile: +98 918 832 2464
Fax:
Email: babaksayad@kums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Reza Khodarahmi
Full name of responsible person - Persian: دکتر رضا خدارحمی
Position - English: Faculty member of Kermanshah University of Medical Sciences
Position - Persian: عضو هیات علمی دانشگاه علوم پزشکی کرمانشاه
Latest degree: specialist
Area of specialty/work: 25
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Emam Reza Hospital, Parastar Boulevard
Street address - Persian: بلوار پرستار، بيمارستان امام رضا
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6715847141
Phone: +98 83 3427 6306
Mobile: +98 912 238 8184
Fax:
Email: rkhodarahmi@mbrc.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Babak SayadReza Khodarahmi Full name of responsible person - Persian: دکتر بابک صیادرضا خدارحمی Position - English: Faculty member of Kermanshah University of Medical Sciences Position - Persian: عضو هیات علمی دانشگاه علوم پزشکی کرمانشاه Latest degree: specialist Area of specialty/work: 6225 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Emam Reza Hospital, Parastar Boulevard Street address - Persian: بلوار پرستار، بيمارستان امام رضا City - English: Kermanshah City - Persian: کرمانشاه Province: Kermanshah Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6715847141 Phone: +98 83 3427 6306 Mobile: +98 918 832 2464912 238 8184 Fax: Email: babaksayadrkhodarahmi@kums.ac.irmbrc.ac.ir Web page address:
Protocol summary
Study aim
Comparative assessment of the efficacy and safety of addon treatment with “Sofosbuvir-Daclatasvir”, “Lithium”, and “Trifluoprazine” to “standard of care in three groups of patients with COVID-19
Design
This study is a single blinded clinical trial. The study population will be all patients infected with COVID-19 admitted to Golestan hospital of Kermanshah. 80 eligible patients will be selected conveniently and randomly assigned to four intervention groups
Settings and conduct
The study, which will be conducted at Golestan Hospital of Kermanshah, is single blinded that participants are unaware of the type of treatment they receive. At the beginning of the study, the patient's clinical status is recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age over 18 years; Absolute lymphocyte count <1100 / ML or SaO2 <93
Exclusion criteria: Pregnancy or breast-feeding; A history of known allergies to Sofosbuvir-Velp, Trifluoperazine, Lithium, and Trihexyphenidyl; Drugs that their concomitant use with standard treatment or Sofosbuvir-Velpatasvir, Trifluoperazine, Lithium, and Trihexyphenidyl are contraindicated and can not be discontinued
Intervention groups
The first group will receive the standard treatment consisted of 200 mg Tab Hydroxychloroquine 2 times every 12 hours on the first day and then one every 12 hours up to 10 days). The second group will receive 60 to 400 mg daily of Tab Sofosbuvir-Daclatasvir for 10 days with standard treatment
The third group will receive 300 mg Tab Lithium every 8 hours for 10 days with standard treatment. The fourth group will receive 5 mg Tab Trifluoprazine every 8 hours and 2 mg Tab Trihexyphenidyl every 8 hours with standard treatment
Main outcome variables
Hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N147
Registration date:2020-04-22, 1399/02/03
Registration timing:registered_while_recruiting
Last update:2020-05-12, 1399/02/23
Update count:1
Registration date
2020-04-22, 1399/02/03
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative assessment of the efficacy and safety of addon treatment with “Sofosbuvir-Daclatasvir”, “Lithium”,and “Trifluoprazine” to “standard of care in three groups of patients with COVID-19
Public title
Comparative assessment of the efficacy and safety of addon treatment with “Sofosbuvir-Daclatasvir”, “Lithium”,and “Trifluoprazine” to “standard of care in three groups of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Absolute lymphocyte count <1100 / ML or SaO2 <93
Exclusion criteria:
Pregnancy or breast-feeding
The physician's decision that the trial is not in the patient's interest
Any circumstances that do not allow the treatment protocol to be followed easily
A history of known allergies to Sofosbuvir-Velp, Trifluoprazine, Lithium and Trihexyphenidyl
Drugs that their concomitant use with standard treatment or Sofosbuvir-Velpatasvir, Trifluoprazine, Lithium, and Trihexyphenidyl are contraindicated and can not be discontinued.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The number of 1 to 80 is written on the cards and will put it in the envelope. Numbers 1-20 are assigned to the first intervention group, numbers 21-40 are assigned to the second intervention group, numbers 41-60 are assigned to the third intervention group, and numbers 61-80 are assigned to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients will be kept blind to the type of treatment. This means that patients are aware of their participation in the study, but they are blind to the type and dosage of the medication they receive and are unaware of the allocation of study groups. Also, due to the fact that outpatients will be considered in this study, and patients separately will come to receive the medication, they will be kept blind about the shape, size, and color of the medication.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-04-11, 1399/01/23
Ethics committee reference number
IR.KUMS.REC.1399.063
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
Not need hospitalization, feels well, and is able to perform normal activities
Timepoint
On days 3, 5 and 10 of treatment
Method of measurement
Based on clinical examination
2
Description
Not need hospitalization, feels ill but is able to perform normal activities
Timepoint
On days 3, 5 and 10 of treatment
Method of measurement
Based on clinical examination
3
Description
Not need hospitalization, feels ill and isn't able to perform normal activities
Timepoint
On days 3, 5 and 10 of treatment
Method of measurement
Based on clinical examination
4
Description
Need hospitalization, feels ill and isn't able to perform normal activities
Timepoint
On days 3, 5 and 10 of treatment
Method of measurement
Based on clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
The first group will receive the standard treatment consisted of 200 mg Tab Hydroxychloroquine 2 times every 12 hours on the first day and then one every 12 hours up to 10 days).
Category
Treatment - Drugs
2
Description
The second group will receive 60 to 400 mg daily of Tab Sofosbuvir-Daclatasvir for 10 days with standard treatment ( 200 mg Tab Hydroxychloroquine 2 times every 12 hours on the first day and then one every 12 hours up to 10 days)
Category
Treatment - Drugs
3
Description
The third group will receive 300 mg Tab Lithium every 8 hours for 10 days with standard treatment ( 200 mg Tab Hydroxychloroquine 2 times every 12 hours on the first day and then one every 12 hours up to 10 days)
Category
Treatment - Drugs
4
Description
The fourth group will receive 5 mg Tab Trifluoprazine every 8 hours and 2 mg Tab Trihexyphenidyl every 8 hours with standard treatment ( 200 mg Tab Hydroxychloroquine 2 times every 12 hours on the first day and then one every 12 hours up to 10 days)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr. Babak Sayad
Street address
Golestan Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
babaksayad@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Babak Sayad
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
babaksayad@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
habibolah khzaei
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farabi Hospital, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851151
Phone
+98 83 3826 1046
Email
hakhazaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Biochemistry
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
rkhodarahmi@mbrc.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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 main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
Send E-mail to the responsible for the update to get the documentation
What processes are involved for a request to access data/document
Documentation will be emailed within a 15-day timeframe