Protocol summary
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Study aim
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Evaluating efficacy and safety of sofosbuvir/ledipasvir in treatment of COVID-19
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Design
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This is an open-label, randomized clinical trial to assess efficacy and safety (phase 2-3) of sofosbuvir/ledipasvir in treatment of COVID-19. Fifty eligible patients will be assigned to intervention or control group according the permuted block randomization.
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Settings and conduct
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After introduction of the study protocol for patients admitted to Imam Khomeini Hospital, Tehran, Iran, and recording consent form, eligible patients will be recruited. Patients will be assigned to the intervention or the control group. Concomitant with the recommended national committee regimen, patients in the intervention group will receive sofosbuvir/ledipasvir 400/90 mg daily for 10 days. The control group will only receive the recommended national committee regimen. During the study period, patients will be monitored for response to the treatment and complications.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 18-75 years old persons with highly suspected or confirmed COVID-19
Exclusion criteria: History of drug allergy, pregnancy and lactation
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Intervention groups
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Included patients will assign to intervention or control group according the permuted block randomization. Concomitant with the national proposed combination, the intervention group will receive one tablet of Sofosbuvir/ledipasevir 400/90 mg daily for 10 days. Patents in the control group will receive only the national proposed combination. Patients will be followed every daily for response to the treatment and adverse reactions up to the end of treatment.
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Main outcome variables
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Primary endpoints of the study are rates of treatment response and adverse drug reactions. Secondary endpoints are duration of hospitalization and patients' clinical outcomes.
General information
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Reason for update
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Edition of the interventions due to changes in the national protocol
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100228003449N29
Registration date:
2020-03-19, 1398/12/29
Registration timing:
registered_while_recruiting
Last update:
2020-03-25, 1399/01/06
Update count:
1
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Registration date
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2020-03-19, 1398/12/29
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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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2020-03-18, 1398/12/28
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Expected recruitment end date
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2020-05-17, 1399/02/28
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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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Evaluating efficacy and safety of sofosbuvir/ ledipasvir in treatment of COVID-19
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Public title
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ٍEffect of sofosbuvir/ ledipasvir on 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:
Patients with highly suspected diagnosis of COVID-19
Patients with confirmed diagnosis of COVID-19
Patients who are candid for hospitalization
Patients who are candid for starting triple-drug combination
Exclusion criteria:
History of drug allergy
Pregnancy
Lactation
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done according to the blocks randomization method. Regarding to the sample size, 5 patients will be include in each block. SAS procedure PROC PLAN will be applied to generate the randomization schedule.
This is a non-blinded randomized clinical trial.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2020-03-17, 1398/12/27
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.1074
Health conditions studied
1
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Description of health condition studied
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COVID-19 pneumonia
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Response to the treatment (improvement of patients' chief complaint, abnormal paraclinic and radiologic findings)
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Timepoint
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Daily
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Method of measurement
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According the clinical, paraclinical and laboratory findings
2
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Description
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Gastrointestinal complications
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Timepoint
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Daily
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Method of measurement
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Interview and patient's record
3
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Description
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Cutaneous complications
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Timepoint
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Daily
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Method of measurement
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Interview and patient's record
4
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Description
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Neurological complications
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Timepoint
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Daily
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Method of measurement
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Interview and patient's record
5
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Description
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Renal complications
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Timepoint
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Daily
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Method of measurement
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Interview and patient's record
6
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Description
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Hematological complications
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Timepoint
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Daily
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Method of measurement
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Interview and patient's record
Secondary outcomes
1
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Description
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Duration of hospitalization
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Timepoint
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End of the treatment
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Method of measurement
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Patient's record
2
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Description
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Clinical outcome (cure or death)
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Timepoint
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End of treatment
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Method of measurement
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Patient's record
Intervention groups
1
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Description
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Intervention group: Concomitant with the national corona treatment recommendation (Tab hydroxychloroquine 400 mg twice daily at day 1 then 200 mg twice daily plus Tab lopinavir/ritonavir 200/50 mg two tablets twice daily for at least 5 days), patients will receive one tablet of sofosbuvir/ledipasvir 400/100 mg (Danesh Pharmaceutical Development Company) daily for 10 days.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients will receive the national corona treatment recommendation (Tab hydroxychloroquine 400 mg twice daily at day 1 then 200 mg twice daily plus Tab lopinavir/ritonavir 200/50 mg two tablets twice daily for at least 5 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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Tehran 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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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript
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When the data will become available and for how long
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One year after finishing the study, data will be published and will be available in databases
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To whom data/document is available
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After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes
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Under which criteria data/document could be used
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Other researchers are permitted to included the results in their systematic reviews and metaanalysis
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From where data/document is obtainable
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For this you may ask Hossein Khalili through following information: Address: Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave.,Tehran, Iran Postal code: 1417614411 E-mail: khalilih@tums.ac.ir
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What processes are involved for a request to access data/document
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After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks
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Comments
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