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Protocol summary
Intervention group: Plasmapheresis 3-5 session (based on clinical improvement), In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus
Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus
Intervention group: Plasmapheresis 3-5 session (based on clinical improvement), In addition to Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virus
Control group: Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virus
Intervention group: Plasmapheresis 3-5 session (based on clinical improvement), In addition to Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virus Control group: RoutineAmp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virus
گروه مداخله: انجام 3 تا 5 جلسه پلاسمافرزیس (بر اساس پاسخ بالینی بیمار، 3تا 5 جلسه تعیین میشود)؛ در کنار درمان روتین طبق آخرین بروزرسانی دستورالعمل کشوری درمان کروناویروس جدید
گروه کنترل: درمان روتین طبق آخرین بروزرسانی دستورالعمل کشوری درمان کروناویروس جدید
گروه مداخله: انجام 3 تا 5 جلسه پلاسمافرزیس (بر اساس پاسخ بالینی بیمار، 3تا 5 جلسه تعیین میشود)؛ به همراه متیل پردنیزولون (روز اول 500 میلی گرم، روز دوم و روز سوم 250 میلی گرم تزریق وریدی)؛ در کنار درمان روتین طبق آخرین بروزرسانی دستورالعمل کشوری درمان کروناویروس جدید
گروه کنترل: متیل پردنیزولون (روز اول 500 میلی گرم، روز دوم و روز سوم 250 میلی گرم تزریق وریدی)؛ در کنار درمان روتین طبق آخرین بروزرسانی دستورالعمل کشوری درمان کروناویروس جدید
گروه مداخله: انجام 3 تا 5 جلسه پلاسمافرزیس (بر اساس پاسخ بالینی بیمار، 3تا 5 جلسه تعیین میشود)؛ به همراه متیل پردنیزولون (روز اول 500 میلی گرم، روز دوم و روز سوم 250 میلی گرم تزریق وریدی)؛ در کنار درمان روتین طبق آخرین بروزرسانی دستورالعمل کشوری درمان کروناویروس جدید گروه کنترل: متیل پردنیزولون (روز اول 500 میلی گرم، روز دوم و روز سوم 250 میلی گرم تزریق وریدی)؛ در کنار درمان روتین طبق آخرین بروزرسانی دستورالعمل کشوری درمان کروناویروس جدید
Intervention groups
#1
Intervention group: Plasmapheresis 3-5 session (based on clinical improvement), In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus
Intervention group: Plasmapheresis 3-5 session (based on clinical improvement), In addition to Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virus
Intervention group: Plasmapheresis 3-5 session (based on clinical improvement), In addition to Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virus
گروه مداخله: انجام 3 تا 5 جلسه پلاسمافرزیس (بر اساس پاسخ بالینی بیمار، 3تا 5 جلسه تعیین میشود)؛ در کنار درمان روتین طبق آخرین بروزرسانی دستورالعمل کشوری درمان کروناویروس جدید
گروه مداخله: انجام 3 تا 5 جلسه پلاسمافرزیس (بر اساس پاسخ بالینی بیمار، 3تا 5 جلسه تعیین میشود)؛ به همراه متیل پردنیزولون (روز اول 500 میلی گرم، روز دوم و روز سوم 250 میلی گرم تزریق وریدی)؛ در کنار درمان روتین طبق آخرین بروزرسانی دستورالعمل کشوری درمان کروناویروس جدید
گروه مداخله: انجام 3 تا 5 جلسه پلاسمافرزیس (بر اساس پاسخ بالینی بیمار، 3تا 5 جلسه تعیین میشود)؛ به همراه متیل پردنیزولون (روز اول 500 میلی گرم، روز دوم و روز سوم 250 میلی گرم تزریق وریدی)؛ در کنار درمان روتین طبق آخرین بروزرسانی دستورالعمل کشوری درمان کروناویروس جدید
#2
Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus
Control group: Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virusfor the treatment of new corona-virus
Control group: RoutineAmp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virusfor the treatment of new corona-virus
گروه کنترل: درمان روتین طبق آخرین بروزرسانی دستورالعمل کشوری درمان کروناویروس جدید
گروه کنترل: متیل پردنیزولون (روز اول 500 میلی گرم، روز دوم و روز سوم 250 میلی گرم تزریق وریدی)؛ در کنار درمان روتین طبق آخرین بروزرسانی دستورالعمل کشوری درمان کروناویروس جدید جدید
گروه کنترل: متیل پردنیزولون (روز اول 500 میلی گرم، روز دوم و روز سوم 250 میلی گرم تزریق وریدی)؛ در کنار درمان روتین طبق آخرین بروزرسانی دستورالعمل کشوری درمان کروناویروس جدید جدید
Protocol summary
Study aim
Investigating the efficacy and safety of Plasmapheresis in patients with moderate to severe COVID-19
Design
This study is a single-center, randomized, open-labeled, controlled and parallel .
Settings and conduct
Patients who is admitted to Baqiyatallah hospital and is meet the inclusion criteria, is entered to the study are randomly assigned into two groups of intervention and control.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation;The patient/Legal guardian has written consciously and freely consent to participate in the study; The patient has moderate to severe Corona-Virus associated pneumonia; In the first 48 hours of hospitalization, the patient did not show an improving trend; In the first 48 hours after his/her inclusion into this study, there is no possibility of discharge from the patient's hospital.
Exclusion Criteria:
Multi organ failure; Pregnancy; Lactation.
Intervention groups
Intervention group: Plasmapheresis 3-5 session (based on clinical improvement), In addition to Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virus
Control group: Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virus
Main outcome variables
Need to receive ICU service
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001165N58
Registration date:2020-05-27, 1399/03/07
Registration timing:registered_while_recruiting
Last update:2020-07-27, 1399/05/06
Update count:1
Registration date
2020-05-27, 1399/03/07
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-29, 1399/02/10
Expected recruitment end date
2020-06-30, 1399/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy and safety of Plasmapheresis in patients with Moderate to severe COVID-19
Public title
Investigating the efficacy and safety of Plasmapheresis in patients with Moderate to severe COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
The patient/Legal guardian has written consciously and freely consent to participate in the study;
The patient has moderate to severe Corona-Virus associated pneumonia;
In the first 48 hours of hospitalization, the patient did not show an improving trend;
In the first 48 hours after his/her inclusion into this study, there is no possibility of discharge from the patient's hospital;
Exclusion criteria:
Multi organ failure;
Pregnancy;
Lactation.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method is used to randomized the patients.
In this method, the number of people assigned to each group is usually almost equal. Blocks are formed based on the considered variables and within each block, half of the people are involved and half are considered as witnesses. The main goal in this method is to balance the number of participants in each group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Science
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-04-26, 1399/02/07
Ethics committee reference number
IR.BMSU.REC.1399.119
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19
Primary outcomes
1
Description
Need to receive ICU service (occurrence of shock, resistant hypoxemia despite receiving oxygen via reservoir oxygen mask, GCS score drops below 12)
Timepoint
The patient is monitored every 6 hours, but the results are recorded daily in the checklist.
Method of measurement
Physical assessment
Secondary outcomes
1
Description
Mortality rate
Timepoint
30 days after including the study
Method of measurement
Physical assessment
2
Description
Length of hospitalization
Timepoint
The first day and the end of hospitalization
Method of measurement
The hospital record review
3
Description
Radiologic response
Timepoint
At the admission, before the discharge
Method of measurement
lung CT-SCAN
4
Description
Laboratory changes
Timepoint
Daily
Method of measurement
Blood sample, laboratory analysis
5
Description
Fever
Timepoint
Daily
Method of measurement
Thermometer
6
Description
Respiratory distress
Timepoint
Daily
Method of measurement
Clinical assessment
7
Description
Oxygen saturation without receiving oxygen supplement
Timepoint
It will be measured every 6 hours, but will be recorded daily
Method of measurement
Pulse-oxymetery device
Intervention groups
1
Description
Intervention group: Plasmapheresis 3-5 session (based on clinical improvement), In addition to Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virus
Category
Treatment - Other
2
Description
Control group: Amp. Methylprednisolone (500 mg day1, 250 mg day 2 and day3, IV) and routine treatment according to the latest national guideline for the treatment of new corona-virusfor the treatment of new corona-virus