Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Parallel double-blind randomized clinical trial study
Parallel single-blind randomized clinical trial study
Parallel doublesingle-blind randomized clinical trial study
کارآزمایی بالینی موازی تصادفی شده دو سو کور
کارآزمایی بالینی موازی تصادفی شده یک سو کور
کارآزمایی بالینی موازی تصادفی شده دویک سو کور
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 + placebo and standard treatment + cyclosporine. Given that patients will be unaware of the type of medication used, therefore, the study will be single blind.
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.
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 + placebo and standard treatment + cyclosporine. Given that patients will be unaware of the type of medication used, therefore, the study will be single blind.
بیماران ,واجد شرایط بستری در بیمارستان سینا همدان پس از اخذ رضایت نامه آگاهانه ، به صورت تصادفی در یکی از دو گروه مورد مطالعه قرار می گیرند. در مورد اهداف مطالعه، اثرات مفيد احتمالي و عوارض احتمالي براي بيماران شرکت کننده در مطالعه و یا بستگان آنها توضيح داده خواهد شد. بیماران با استفاده از بلوکهای تصادفی چهارتایی در دو گروه دریافت کننده درمان استاندارد Covid-19 + پلاسبو و درمان استاندارد + سیکلوسپورین قرار می گیرند. با توجه به ان که بیمار از نوع داروی مورد استفاده توسط بیماران بی اطلاع خواهند بود. بنابراین مطالعه به صورت یک سو کور اجرا خواهد شد.
بیماران ,واجد شرایط بستری در بیمارستان سینا همدان پس از اخذ رضایت نامه آگاهانه ، به صورت تصادفی در یکی از دو گروه مورد مطالعه قرار می گیرند. در مورد اهداف مطالعه، اثرات مفيد احتمالي و عوارض احتمالي براي بيماران شرکت کننده در مطالعه و یا بستگان آنها توضيح داده خواهد شد. بیماران با استفاده از بلوکهای تصادفی چهارتایی در دو گروه دریافت کننده درمان استاندارد Covid-19 و درمان استاندارد + سیکلوسپورین قرار می گیرند. با توجه به ان که بیمار از نوع داروی مورد استفاده توسط بیماران بی اطلاع خواهند بود. بنابراین مطالعه به صورت یک سو کور اجرا خواهد شد.
بیماران ,واجد شرایط بستری در بیمارستان سینا همدان پس از اخذ رضایت نامه آگاهانه ، به صورت تصادفی در یکی از دو گروه مورد مطالعه قرار می گیرند. در مورد اهداف مطالعه، اثرات مفيد احتمالي و عوارض احتمالي براي بيماران شرکت کننده در مطالعه و یا بستگان آنها توضيح داده خواهد شد. بیماران با استفاده از بلوکهای تصادفی چهارتایی در دو گروه دریافت کننده درمان استاندارد Covid-19 + پلاسبو و درمان استاندارد + سیکلوسپورین قرار می گیرند. با توجه به ان که بیمار از نوع داروی مورد استفاده توسط بیماران بی اطلاع خواهند بود. بنابراین مطالعه به صورت یک سو کور اجرا خواهد شد.
Intervention group: Receiving routine treatment (according to national protocol) + Cyclosporine and Control group: Receiving routine treatment (according to national protocol) + placebo
Intervention group: Receiving routine treatment (according to national protocol) + Cyclosporine and Control group: Receiving routine treatment (according to national protocol)
Intervention group: Receiving routine treatment (according to national protocol) + Cyclosporine and Control group: Receiving routine treatment (according to national protocol) + placebo
گروه مداخله: درمان روتین کووید 19 (مطابق پروتکل کشوری)+ سیکلوسپورین و گروه کنترل درمان روتین کووید-19 (مطابق پروتکل کشوری) + پلاسبو را دریافت خواهد کرد.
گروه مداخله: درمان روتین کووید 19 (مطابق پروتکل کشوری)+ سیکلوسپورین و گروه کنترل درمان روتین کووید-19 (مطابق پروتکل کشوری) را دریافت خواهد کرد.
گروه مداخله: درمان روتین کووید 19 (مطابق پروتکل کشوری)+ سیکلوسپورین و گروه کنترل درمان روتین کووید-19 (مطابق پروتکل کشوری) + پلاسبو را دریافت خواهد کرد.
General information
Double blinded
Single blinded
doublsingl
1
1
Used
Not used
usednused
empty
Removing placcebo
Removing placcebo
empty
حذف پلاسبو
حذف پلاسبو
Intervention groups
#1
Control group: The routine treatments (The last national protocol for COVID-19 treatment) + placebo will be given to these patients according to the physician's supervision.
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.
Control group: The routine treatments (The last national protocol for COVID-19 treatment) + placebo will be given to these patients according to the physician's supervision.
گروه کنترل: این بیماران درمان استاندارد (مطابق با آخرین پروتکل کشوری) کووید-19 + پلاسبو را تحت نظارت دریافت خواهد نمود.
گروه کنترل: این بیماران درمان استاندارد (مطابق با آخرین پروتکل کشوری) کووید-19 را تحت نظارت دریافت خواهد نمود.
گروه کنترل: این بیماران درمان استاندارد (مطابق با آخرین پروتکل کشوری) کووید-19 + پلاسبو را تحت نظارت دریافت خواهد نمود.
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Salman Khazaei
Full name of responsible person - Persian: سلمان خزایی
Position - English: Assistance professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 2
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Fahmideh
Street address - Persian: شهید فهمیده
City - English: Hamedan
City - Persian: همدان
Province: Hamadan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3838 0548
Mobile: +98 918 150 1628
Fax:
Email: salman.khazaei61@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Behshad Naghshtabrizi
Full name of responsible person - Persian: بهشاد نقش تبریزی
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 71
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Fahmideh
Street address - Persian: شهید فهمیده
City - English: Hamedan
City - Persian: همدان
Province: Hamadan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3838 0548
Mobile: +98 912 349 3924
Fax:
Email: behshadnaghshtabrizi@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Salman KhazaeiBehshad Naghshtabrizi Full name of responsible person - Persian: سلمان خزاییبهشاد نقش تبریزی Position - English: Assistance professorAssociate Professor Position - Persian: استادیاردانشیار Latest degree: phdspecialist Area of specialty/work: 271 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Fahmideh Street address - Persian: شهید فهمیده City - English: Hamedan City - Persian: همدان Province: Hamadan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6517838695 Phone: +98 81 3838 0548 Mobile: +98 918 150 1628912 349 3924 Fax: Email: salman.khazaei61behshadnaghshtabrizi@gmail.comyahoo.com Web page address:
Protocol summary
Study aim
Determining the effect of cyclosporine on clinical improvement and prognosis of patients with Covid-19
Design
Parallel single-blind randomized clinical trial study
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
Intervention group: Receiving routine treatment (according to national protocol) + Cyclosporine and Control group: Receiving routine treatment (according to national protocol)
Main outcome variables
Clinical outcome and prognosis of patients with Covid-19
General information
Reason for update
Removing placcebo
Acronym
IRCT registration information
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
Registration date
2020-07-21, 1399/04/31
Registrant information
Name
Salman Khazaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0548
Email address
salman.khazaei61@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Cyclosporine in prognosis and clinical improvement in patients with COVID-19: A Randomized Clinical Trial Study
Public title
The effect of Cyclosporine in prognosis and clinical improvement in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
We describe two treatment groups for the patients, but allocation to group are random and patients are not aware from allocation
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838778
Approval date
2020-07-11, 1399/04/21
Ethics committee reference number
IR.UMSHA.REC.1399.355
Health conditions studied
1
Description of health condition studied
COVID-19 disease
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Change oxygenation
Timepoint
Daily for two weeks
Method of measurement
pulse oximeter
2
Description
Creatinine clearance status
Timepoint
Days 2, 4 and 6
Method of measurement
laboratory exam
3
Description
Inflammatory factors
Timepoint
Days 1 and 7
Method of measurement
Flow Cytometry
4
Description
Number of days hospitalized in the ward
Timepoint
Seventh day onward
Method of measurement
day
5
Description
Serum D.dimer
Timepoint
Days 1,3 and 7
Method of measurement
Enzymes
6
Description
Serum ferritin level
Timepoint
Days 1,3 and 7
Method of measurement
laboratory test
7
Description
TCD4+, TCD8+, B Cell
Timepoint
Days 1 and 7
Method of measurement
Flow Cytometry
8
Description
CRP
Timepoint
Days 1 and 7
Method of measurement
mg/L
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Fariba Keramat
Street address
Mirzadeh Eshghi Street
City
Hamadan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 3827 4184
Email
faribakeramat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6571838678
Phone
+98 81 3838 0717
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Salman Khazaei
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Fahmideh
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0548
Fax
Email
salman.khazaei61@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behshad Naghshtabrizi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Fahmideh
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0548
Fax
Email
behshadnaghshtabrizi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Salman Khazaei
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Fahmideh
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0548
Fax
Email
salman.khazaei61@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available