Protocol summary
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Study aim
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Comparison of the effectiveness and safety of the addition of Sofosbuvir plus Velpatasvir to standard treatment regimens in patients with COVID-19
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Design
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This study is one 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 two 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 one-blinded one 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
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 severe liver disease including cirrhosis or ALT or AST levels more than fives times normal
Drugs that are contraindicated with standard treatment or Sofosbuvir-Velpatasvir and cannot be discontinued
History of untreated HIV infection or hepatitis C
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Intervention groups
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The intervention group in addition to 400 mg of hydroxychloroquine and 100 to 400 mg of Lupinavir-ritonavir at a time, will receive 100 to 400 mg of Sofosbuvir-Velpatasvir for 10 days.
The control group will receive 400 mg of hydroxychloroquine and 100 to 400 mg of lupinavir-ritonavir for 10 days at a time.
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Main outcome variables
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Clinical status
General information
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Reason for update
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Edite spelling in the title
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Acronym
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SOVECOD
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IRCT registration information
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IRCT registration number:
IRCT20130812014333N145
Registration date:
2020-03-30, 1399/01/11
Registration timing:
prospective
Last update:
2020-04-07, 1399/01/19
Update count:
2
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Registration date
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2020-03-30, 1399/01/11
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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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2020-07-10, 1399/04/20
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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 add ontreatment with “Sofosbuvir plus Velpatasvir” to “standard of care therapeutic regimen” in patients with COVID-19
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Public title
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Comparative assessment of the efficacy and safety of add ontreatment with “Sofosbuvir standard of care therapeutic regimenVelpatasvir” to “standard of caretherapeutic regimen” in 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 to follow the treatment protocol easily
A history of severe liver disease including cirrhosis or ALT or AST levels more than fives times normal
Drugs that are contraindicated with standard treatment or Sofosbuvir-Velpatasvir and cannot be discontinued
History of untreated HIV infection or hepatitis C
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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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Using the random number table, patients are divided into two groups of 40. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be 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.
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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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2020-03-03, 1398/12/13
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Ethics committee reference number
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Ir.kums.rec.1399.044
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 disease
Primary outcomes
1
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Description
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Clinical status
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Timepoint
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Beginning of the study, 10 days later, or discharge time
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Method of measurement
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By a doctor
Intervention groups
1
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Description
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The intervention group in addition to standard treatment (400 mg of hydroxychloroquine and 100 to 400 mg of Lupinavir-ritonavir at a time), will receive 100 to 400 mg of Sofosbuvir-Velpatasvir for 10 days.
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Category
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Treatment - Drugs
2
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Description
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The control group will receive standard treatment including 400 mg of hydroxychloroquine and 100 to 400 mg of lupinavir-ritonavir for 10 days at a time.
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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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4 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 45-day timeframe
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Comments
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