Evaluation of the effectiveness of plasmapheresis treatment in patients with severe coronavirus with symptoms of pulmonary involvement
Design
Clinical trial with control group, with parallel, non-blind, randomized, phase 3 groups on 70 patients.
Settings and conduct
70 patients admitted to Seyed Al-Shohada and Al-Zahra Hospitals, Isfahan University of Medical Sciences with a definitive diagnosis of COVID-19 in 2021 will be included in the study in a non-probable manner based on inclusion criteria after obtaining informed consent.Patients in the control group will receive routine treatments for Covid disease. The case group, in addition to routine treatment, undergoes centrifugation plasmapheresis with FFP replacement.
Participants/Inclusion and exclusion criteria
Age over 18 years
No pregnancy
Do not get diseases that require a special treatment protocol
Patient with cytokine storm
Life-threatening illnesses such as respiratory failure, septic shock, dysfunction or multiple organ failure
early ARDS
Severe drug side effects leading to protocol changes.
Acute coronary syndrome
Severe sensitivity to FFP
Uncontrolled heart failure
Pulmonary embolism
Intervention groups
Divide into two equal case-control groups in parallel
Patients in the control group will receive routine treatments for Covid disease. The case group, in addition to routine treatment, undergoes centrifugation plasmapheresis with FFP replacement
Main outcome variables
Reduce mortality rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200414047076N2
Registration date:2021-09-08, 1400/06/17
Registration timing:registered_while_recruiting
Last update:2021-09-08, 1400/06/17
Update count:0
Registration date
2021-09-08, 1400/06/17
Registrant information
Name
Elahe Nasri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 8006
Email address
elahe.nasri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Plasmapheresis Treatment for the Management of Patients with Severe COVID19
Public title
The assessment of the effect of plasmapheresis treatment for the management of sever COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
No pregnancy
Do not get diseases that require a special treatment protocol
Patient with cytokine storm
Life-threatening illnesses such as respiratory failure, septic shock, dysfunction or multiple organ failure
early ARDS
Exclusion criteria:
Age under 18 years
pregnancy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized allocation will be done by some one who is not among the study researchers. The codes of participants will be entered in SPSS software which will allocated randomly to intervention or control groups.
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 Isfahan University of Medical Sciences
Street address
Hezar jarib
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-06-26, 1399/04/06
Ethics committee reference number
IR.MUI.MED.REC.1400.195
Health conditions studied
1
Description of health condition studied
Covid-19,Plasmapheresis
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
The prevalence of mortality/morbidity
Timepoint
Three plasmapheres with one or two days apart, examinations and tests in both groups every other day for two weeks and then every week for two weeks
Method of measurement
Patients' lab and file records
Secondary outcomes
1
Description
Determining the trend of O2 sat level changes in patients treated with plasmapheresis compared with the control group
Timepoint
daily
Method of measurement
pulse oximetre
2
Description
Determining the trend of LDH level changes in patients treated with plasmapheresis compared with the control group
Timepoint
daily
Method of measurement
Laboratory test
3
Description
Determining the trend of changes in ESR level in patients treated with plasmapheresis compared with the control group
Timepoint
daily
Method of measurement
Laboratory test
4
Description
Determining the trend of changes in CRP level in patients treated with plasmapheresis compared with the control group
Timepoint
daily
Method of measurement
Laboratory test
5
Description
Determining the trend of changes in ferritin level in patients treated with plasmapheresis compared with the control group
Timepoint
daily
Method of measurement
Laboratory test
6
Description
Determining the trend of changes in D-Dimer level in patients treated with plasmapheresis compared with the control group
Timepoint
daily
Method of measurement
ELISA
7
Description
Determining the trend of mortality rate changes in patients treated with plasmapheresis compared with the control group
Timepoint
daily
Method of measurement
patient file report
8
Description
Determining the mean length of hospital stay in patients treated with plasmapheresis compared with the control group
Timepoint
daily
Method of measurement
Questionnaire
Intervention groups
1
Description
The intervention group: The COVID-19 patients who will receive Centrifugation plasmapheres which are replaced by FFP. The Plasmapheresis , Lab tests and clinical examinations will be done every other day for treatment decision making. The treatment with plasmapheresis will be 3-5 times.
Category
Treatment - Other
2
Description
Control group: Patients will receive routine treatments for Covid disease
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital, Omid Hospital
Full name of responsible person
Elahe Nasri
Street address
Kaveh
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 21 8670 5503
Email
elahe.nasri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaghayegh haghjoo
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Research of Isfahan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Elahe Nasri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
elahe.nasri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elahe nasri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Hezar jarib
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
elahe.nasri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
صفیه غافل
Position
Research Assistant
Latest degree
Master
Other areas of specialty/work
Infectious diseases
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
safighafel@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Collect information in the form of articles
When the data will become available and for how long
One year
To whom data/document is available
all
Under which criteria data/document could be used
After publishing the article
From where data/document is obtainable
executor of plan
What processes are involved for a request to access data/document
Send your request via email
Comments
Due to the importance of treating patients with COVID 19, any guidance and questions will be answered by the facilitator