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Protocol summary
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، تک سویه کور ، تصادفی شده، فاز 2 بر روی 20 بیمار. برای تصادفی سازی از نرم افزار RAS (Random Allocation Sofware) استفاده می شود.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، تک سویه کور، تصادفی شده، فاز 2 بر روی 20 بیمار. برای تصادفی سازی از نرم افزار RAS (Random Allocation Software) استفاده می شود.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، تک سویه کور، تصادفی شده، فاز 2 بر روی 20 بیمار. برای تصادفی سازی از نرم افزار RAS (Random Allocation SofwareSoftware) استفاده می شود.
20 بیمار 60-20 ساله مبتلا به Covid19 که در بخش مراقبت های ویژه بستری شده اند به روش نمونه گیری در دسترس وارد مطالعه می شوند و به صورت تصادفی به دو گروه برای دریافت 1) اتوهموتراپی ازون همراه با درمان های مرسوم و 2)درمان های مرسوم تخصیص داده می شوند. اتوهموتراپی سه بار در هفته و به تعداد 10 بار در کل انجام می گیرد.
20 بیمار 60-20 ساله مبتلا به Covid19 که در بخش مراقبت های ویژه بستری شده اند به روش نمونه گیری در دسترس وارد مطالعه می شوند و به صورت تصادفی به دو گروه برای دریافت 1) اتوهموتراپی ازون همراه با درمان های مرسوم و 2) درمان های مرسوم تخصیص داده میشوند. اتوهموتراپی سه بار در هفته و به تعداد 10 بار در کل انجام میگیرد.
20 بیمار 60-20 ساله مبتلا به Covid19 که در بخش مراقبت های ویژه بستری شده اند به روش نمونه گیری در دسترس وارد مطالعه می شوند و به صورت تصادفی به دو گروه برای دریافت 1) اتوهموتراپی ازون همراه با درمان های مرسوم و 2)درمان2) درمان های مرسوم تخصیص داده می شوندمیشوند. اتوهموتراپی سه بار در هفته و به تعداد 10 بار در کل انجام می گیردمیگیرد.
General information
empty
Updating the inclusion and exclusion criteria
Updating the inclusion and exclusion criteria
empty
به روزرسانی معیارهای ورود و خروج
به روزرسانی معیارهای ورود و خروج
Documented Covid19 patients
With age 20-60 years
Admission to Intensive Care Unit
Being 20-60 years of age
Having a positive reverse-transcriptase polymerase chain reaction test for SARS-CoV-2
Being admitted to the intensive care unit
Receiving invasive mechanical ventilation that began a short time before admission or in the intensive care unit
Documented Covid19 patients With ageBeing 20-60 years Admissionof age Having a positive reverse-transcriptase polymerase chain reaction test for SARS-CoV-2 Being admitted to Intensive Care Unitthe intensive care unit Receiving invasive mechanical ventilation that began a short time before admission or in the intensive care unit
بیماران Covid19 ثابت شده
سن 60-20 سال
بستری در بخش مراقبت های ویژه
سن 20 تا 60 سال
مثبت بودن تست واکنش زنجیره ای پلیمراز ترانس کریپتاز معکوس برای SARS-CoV-2
بستری شدن در بخش مراقبت های ویژه
دریافت تهویه مکانیکی تهاجمی که مدت کوتاهی قبل از پذیرش یا در بخش مراقبت‌های ویژه شروع شده است
بیماران Covid19 ثابت شده سن 20 تا 60-20 سال مثبت بودن تست واکنش زنجیره ای پلیمراز ترانس کریپتاز معکوس برای SARS-CoV-2 بستری شدن در بخش مراقبت های ویژه دریافت تهویه مکانیکی تهاجمی که مدت کوتاهی قبل از پذیرش یا در بخش مراقبت‌های ویژه شروع شده است
History of blood disorders
History of liver failure
History of renal failure
History of chronic obstructive pulmonary disease
Patients with an anticipated survival length of fewer than 24 hours
Patients with a body mass index of 35 kg/m2 and over
Patients with a history of blood disorders
Patients with a history of renal or liver failure or chronic obstructive pulmonary disease
Pregnant or lactating women
Patients who were joined in other clinical trials
HistoryPatients with an anticipated survival length of fewer than 24 hours Patients with a body mass index of 35 kg/m2 and over Patients with a history of blood disorders HistoryPatients with a history of renal or liver failure History of renal failure History ofor chronic obstructive pulmonary disease Pregnant or lactating women Patients who were joined in other clinical trials
سابقه ابتلا به اختلالات خونی
سابقه نارسایی کبدی
سابقه نارسایی کلیوی
سابقه بیماری مزمن انسدادی ریه
بیماران با طول عمر پیش بینی شده کمتر از 24 ساعت
بیماران با شاخص توده بدنی 35 کیلوگرم بر متر مربع و بالاتر
بیماران با سابقه اختلالات خونی
بیماران با سابقه نارسایی کلیوی یا کبدی یا بیماری مزمن انسدادی ریه
زنان باردار یا شیرده
بیمارانی که در کارآزمایی‌های بالینی دیگر ملحق شده اند
بیماران با طول عمر پیش بینی شده کمتر از 24 ساعت بیماران با شاخص توده بدنی 35 کیلوگرم بر متر مربع و بالاتر بیماران با سابقه ابتلا به اختلالات خونی سابقه نارسایی کبدیبیماران با سابقه نارسایی کلیوی سابقهیا کبدی یا بیماری مزمن انسدادی ریه زنان باردار یا شیرده بیمارانی که در کارآزمایی‌های بالینی دیگر ملحق شده اند
شرکت کنندگان، مسئولین جمع آوری داده ها،کسانی که پیامد را ارزیابی می کنند و نیز فرد مسئول آنالیز داده ها به تخصیص تصادفی بررسی شوندگان به گروه های مطالعه کور نگه داشته می شوند.
شرکت کنندگان، مسئولین جمع آوری داده ها، کسانی که پیامد را ارزیابی می کنند و نیز فرد مسئول آنالیز داده ها به تخصیص تصادفی بررسی شوندگان به گروه های مطالعه کور نگه داشته می شوند.
شرکت کنندگان، مسئولین جمع آوری داده ها،کسانی که پیامد را ارزیابی می کنند و نیز فرد مسئول آنالیز داده ها به تخصیص تصادفی بررسی شوندگان به گروه های مطالعه کور نگه داشته می شوند.
Protocol summary
Study aim
Determining the effect of Ozone Autohemotherapy on clinical and paraclinical features of patients with Covid10
Design
A controlled clinical trial, with parallel groups, single-blinded, randomized, phase 2 on 20 patients. RAS (Random Allocation Sofware) software will be used for randomization.
Settings and conduct
Twenty 20-60 years old patients with Covid19 who are admitted to the intensive care unit will be entered the study using the convenient sampling method and will be randomly allocated into two groups to receive 1) Ozone Autohemotherapy with conventional therapies or 2) conventional therapies. Autohemotherapy will be given three times a week for 10 times in total.
Participants/Inclusion and exclusion criteria
Documented Covid19 patients with age 20-60 years and admission to Intensive Care Unit
Intervention groups
Ozone Autohemotherapy, Injection of 100 ml of ozone at a concentration of 30micro / mL O2-O3 mixed with 100ml of patient's own heparinized blood will be given three times a week for a total of 10 times.
Main outcome variables
Complete Blood cell count and diffrential count, liver function tests and renal function test
General information
Reason for update
Updating the inclusion and exclusion criteria
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043923N4
Registration date:2020-05-04, 1399/02/15
Registration timing:registered_while_recruiting
Last update:2023-05-13, 1402/02/23
Update count:1
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 1928
Email address
aghamohammadi.d@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-25, 1399/02/06
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effects medical Ozone Autohemotherapy on clinical and para clinical features of patients with Covid19
Public title
Ozone Autohemotherapy in Covid19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being 20-60 years of age
Having a positive reverse-transcriptase polymerase chain reaction test for SARS-CoV-2
Being admitted to the intensive care unit
Receiving invasive mechanical ventilation that began a short time before admission or in the intensive care unit
Exclusion criteria:
Patients with an anticipated survival length of fewer than 24 hours
Patients with a body mass index of 35 kg/m2 and over
Patients with a history of blood disorders
Patients with a history of renal or liver failure or chronic obstructive pulmonary disease
Pregnant or lactating women
Patients who were joined in other clinical trials
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
A block randomization method will be used to allocate participants to the groups with a 1:1 allocation using random allocation software (RAS). Similar sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants, data collection officials, those who evaluate the outcome and the person responsible for data analysis will be blinded to random allocation of participants to study groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
3692588521
Approval date
2020-04-13, 1399/01/25
Ethics committee reference number
IR.TBZMED.REC.1399.022
Health conditions studied
1
Description of health condition studied
Coronavirus infection
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Complete Blood cell count and diffrential count
Timepoint
Complete Blood cell count and diffrential count at the beginning of the study (before the intervention) and 7, 14 and 21 days after the start of ozone autohemotherapy
Method of measurement
Biochemical analysis
2
Description
Liver function tests
Timepoint
Liver function tests at the beginning of the study (before the intervention) and 7, 14 and 21 days after the start of ozone autohemotherapy
Method of measurement
Biochemical analysis
3
Description
Renal function tests
Timepoint
Renal function tests at the beginning of the study (before the intervention) and 7, 14 and 21 days after the start of ozone autohemotherapy
Method of measurement
Biochemical analysis
Secondary outcomes
1
Description
Mechanical ventilator weaning time
Timepoint
Mechanical ventilator weaning time during the study after the start of ozone autohemotherapy
Method of measurement
Comment by the treating physician
Intervention groups
1
Description
Intervention group: Major Autohemotherapy with common treatments. 100 ml of the patient heparinized blood is mixed with 100 ml of ozone at a concentration of 30micro /mL O2-O3 and injected again. These injections are given 3 times a week for a total of 10 times.
Category
Treatment - Drugs
2
Description
Control group: Common treatments
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dawood Aghamohammadi
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
3692588521
Phone
+98 41 3334 4280
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@yahoo.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