Protocol summary
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Study aim
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Determining the effect of cyclosporine on clinical improvement and prognosis of patients with Covid-19
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Design
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Parallel single-blind randomized clinical trial study
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Settings and conduct
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Eligible patients hospitalized in Sina Hospital are randomly assigned to one of two groups after receiving informed consent. The objectives of the study, possible beneficial effects and possible side effects for the patients participating in the study or their relatives will be explained. Patients using balanced blocks randomization are divided into two groups including receiving standard treatment of Covid-19 and standard treatment + cyclosporine. Given that patients will be unaware of the type of medication used, therefore, the study will be single blind.
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Participants/Inclusion and exclusion criteria
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18-60 years patients with PCR positive test, with acute respiratory infectious symptoms and severe lung involvement, will be included in the study and pregnant or lactating women patients or patients with cancer or intubated exclude from the study.
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Intervention groups
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Intervention group: Receiving routine treatment (according to national protocol) + Cyclosporine and Control group: Receiving routine treatment (according to national protocol)
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Main outcome variables
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Clinical outcome and prognosis of patients with Covid-19
General information
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Reason for update
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Removing placcebo
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200426047206N3
Registration date:
2020-07-21, 1399/04/31
Registration timing:
prospective
Last update:
2020-07-25, 1399/05/04
Update count:
1
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Registration date
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2020-07-21, 1399/04/31
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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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2020-07-22, 1399/05/01
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Expected recruitment end date
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2020-11-21, 1399/09/01
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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 the effect of Cyclosporine in prognosis and clinical improvement in patients with COVID-19: A Randomized Clinical Trial Study
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Public title
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The effect of Cyclosporine in prognosis and clinical improvement 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:
Positive PCR test
Age between 18-60 years
patient with acute respiratory infectious symptoms and lung involvement
non-intubated patients
Exclusion criteria:
Allergy to Cyclosporin
Not willing to participate
Patients with cancer
Under treatment with immunosuppressor drugs
Pregnancy or breastfeeding
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Age
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From 18 years old to 60 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:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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For this purpose, we will use the BalancedBlock Randomization method (block size=4). Random allocation software will be used for this purpose. At first, we prepare two sheets of paper. We write "Intervention" on a paper and "Standard treatment" on another. Mix the sheets together and place them on the desk drawer. With the referral of each of the eligible patients, one of the cards will be drawn randomly and based on this drawn card, it will be assigned to one of the two groups. It should be noted that the drawn sheets will not be returned to the drawer until all four sheets have been removed. After all four sheets are drawn randomly, all the sheets are returned to the drawer and the above operation will be continued for the next four patients until the desired sample size is reached.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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We describe two treatment groups for the patients, but allocation to group are random and patients are not aware from allocation
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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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2020-07-11, 1399/04/21
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Ethics committee reference number
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IR.UMSHA.REC.1399.355
Health conditions studied
1
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Description of health condition studied
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COVID-19 disease
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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
Primary outcomes
1
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Description
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Change oxygenation
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Timepoint
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Daily for two weeks
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Method of measurement
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pulse oximeter
2
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Description
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Creatinine clearance status
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Timepoint
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Days 2, 4 and 6
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Method of measurement
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laboratory exam
3
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Description
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Inflammatory factors
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Timepoint
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Days 1 and 7
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Method of measurement
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Flow Cytometry
4
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Description
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Number of days hospitalized in the ward
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Timepoint
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Seventh day onward
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Method of measurement
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day
5
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Description
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Serum D.dimer
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Timepoint
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Days 1,3 and 7
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Method of measurement
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Enzymes
6
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Description
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Serum ferritin level
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Timepoint
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Days 1,3 and 7
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Method of measurement
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laboratory test
7
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Description
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TCD4+, TCD8+, B Cell
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Timepoint
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Days 1 and 7
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Method of measurement
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Flow Cytometry
8
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Description
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CRP
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Timepoint
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Days 1 and 7
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Method of measurement
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mg/L
Intervention groups
1
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Description
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Intervention group: Patients receive low-dose cyclosporine for at least 7 days orally.Also, the routine treatments (The last national protocol for COVID-19 treatment) will be given to patients according to the physician's supervision.
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Category
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Treatment - Drugs
2
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Description
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Control group: The routine treatments (The last national protocol for COVID-19 treatment) will be given to these patients according to the physician's supervision.
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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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No
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Title of funding source
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Hamadan 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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Undecided - It is not yet known if there will be 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