Protocol summary
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Study aim
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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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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Hospitalization
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2020-04-22, 1399/02/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-08, 1399/01/20
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Expected recruitment end date
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2020-06-09, 1399/03/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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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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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-11, 1399/01/23
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Ethics committee reference number
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IR.KUMS.REC.1399.063
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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Not need hospitalization, feels well, and is able to perform normal activities
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Timepoint
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On days 3, 5 and 10 of treatment
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Method of measurement
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Based on clinical examination
2
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Description
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Not need hospitalization, feels ill but is able to perform normal activities
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Timepoint
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On days 3, 5 and 10 of treatment
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Method of measurement
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Based on clinical examination
3
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Description
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Not need hospitalization, feels ill and isn't able to perform normal activities
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Timepoint
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On days 3, 5 and 10 of treatment
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Method of measurement
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Based on clinical examination
4
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Description
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Need hospitalization, feels ill and isn't able to perform normal activities
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Timepoint
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On days 3, 5 and 10 of treatment
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Method of measurement
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Based on clinical examination
Intervention groups
1
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Description
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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).
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Category
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Treatment - Drugs
2
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Description
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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)
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Category
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Treatment - Drugs
3
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Description
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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)
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Category
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Treatment - Drugs
4
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Description
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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)
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kermanshah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The main outcomes of the study will be shared.
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When the data will become available and for how long
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3 months
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To whom data/document is available
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If requested, results will be made available to other academic researchers
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Under which criteria data/document could be used
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Collected data is confidential and will not be shared with anyone else
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From where data/document is obtainable
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Send E-mail to the responsible for the update to get the documentation
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What processes are involved for a request to access data/document
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Documentation will be emailed within a 15-day timeframe
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Comments
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