Protocol summary
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Study aim
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Evaluating efficacy and safety of interferone β-1b (IFN β-1b) in the treatment of COVID-19
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Design
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This is a non-blinded randomized clinical trial.Included 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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This study will be done in Imam Khomeini Hospital.
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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
Uncontrolled baseline diseases including neuropsychiatric disorders, thyroid disorders, heart disease
Pregnancy and lactation
Baseline liver failure
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Intervention groups
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Concomitant with the national proposed combination, the intervention group will receive interferon β-1b (Zist Daru Daneh Company), 250 mcg subcutaneously every other day for 14 days. Patents in the control group will receive only the national proposed combination. Patients will be followed every other day 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:
IRCT20100228003449N27
Registration date:
2020-03-16, 1398/12/26
Registration timing:
registered_while_recruiting
Last update:
2020-03-25, 1399/01/06
Update count:
2
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Registration date
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2020-03-16, 1398/12/26
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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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2020-03-15, 1398/12/25
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Expected recruitment end date
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2020-05-14, 1399/02/25
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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 interferone β-1b (IFN β-1b) in the treatment of COVID-19
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Public title
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Interferon β in treatment of 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 or confirmed COVID-19 who are candid for hospitalization and starting triple-drug combination.
Exclusion criteria:
History of drug allergy
Pregnancy and lactation
Uncontrolled baseline diseases including neuropsychiatric disorders, diabetes, thyroid disorders, heart disease, baseline liver failure
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Age
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From 18 years old to 65 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:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients with inclusion criteria of the study will be recruited in the intervention or the control group according the permuted block randomization (5 blocks and 3 patients in each block)
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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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2020-03-14, 1398/12/24
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.1053
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
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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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Complications of the treatment
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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
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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 (hydroxychloroquine + lopinavir/ritonavir), patients will receive interferon β, sub-type 1b (Zist Daru Daneh Company) with dose of 250 mcg subcutaneously every other day for 14 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 (hydroxychloroquine + lopinavir/ritonavir) 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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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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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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