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Investigaing the hemoperfusion effect on the recovery of hospitalized patients with severe COVID-19 symptoms in Imam Khomeini Hospital, Urmia; a before-after pilot study

Protocol summary

Study aim
Determining the effect of hemoperfusion on the improvement of symptoms of Covid-19 patients who are hospitalized with severe symptoms and the symptoms are resistant to common treatments
Design
A single-arm clinical trial without blinding and randomization on a group of patients involving at least 20 patients
Settings and conduct
Patients admitted to Imam Khomeini Hospital in Urmia with severe symptoms of COVID-19 will undergo hemoperfusion in two sessions . The variables studied in this study include para-clinical examinations ( WBC changes, renal and hepatic profile), hospitalization period , age, sex and body mass index, vital signs .after completion of two session of hemoperfusion (blood pressure, heart rate, respiration rate, arterial blood oxygen level) , pulmonary involvement severity( according to control CT- scans),and mortality will be recorded . Complications of hemoperfusion related to catheter insersion and complication occured during the hemoperfusion will be recorded too
Participants/Inclusion and exclusion criteria
Patients with severe symptoms following Covid-19 with pulmonary involvement according to CT scan more than 50%, and in patients with pulmonary involvement less than 50% who has respiratory distress, or despite receiving oxygen with a reservoir mask or non-invasive ventilation So2 is less than 88 % And the patients should not have any coagulation disorder, vasculitis, sepsis and malignancy and severe underlying disease that reduces life expectancy
Intervention groups
Patients will undergo hemoperfusion for 3 hours with a special cartridge to remove inflammatory cytokines that damage the organs through a femoral catheter. Then the patient's symptoms are evaluated if necessary Another 3-hour hemoperfusion session is performed
Main outcome variables
respiratory status based on SO2, renal and hepatic function , State of consciousness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180625040232N7
Registration date: 2020-11-30, 1399/09/10
Registration timing: registered_while_recruiting

Last update: 2020-11-30, 1399/09/10
Update count: 0
Registration date
2020-11-30, 1399/09/10
Registrant information
Name
Saman Farshid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
farshid.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2021-02-08, 1399/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigaing the hemoperfusion effect on the recovery of hospitalized patients with severe COVID-19 symptoms in Imam Khomeini Hospital, Urmia; a before-after pilot study
Public title
The effect of hemoperfusion on patients with severe symptoms of covid-19 which are resistant to conventional therapies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Covid-19 patients admitted with severe symptoms who do not respond to conventional therapies based on guidelines satiscfaction with performing of hemoperfusion lung involvement more than 50% according to Chest- CT imaging In patients with lungs involvement less than 50% with respiratory distress, or SO2 less than 88%, despite receiving supplementory oxygen with a reservoir mask or NIV
Exclusion criteria:
uncorrected coagulopathy in patients vasculitis sepsis Patients with low life expectancy due to underlying disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Blvd-Emergency Alley, Urmia, Vest Azarbaijan
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2020-11-11, 1399/08/21
Ethics committee reference number
IR.UMSU.REC.1399.259

Health conditions studied

1

Description of health condition studied
Hospitalized patients with COVID-19 symptoms
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Respiratory status regarding So2
Timepoint
After performing of two session hemoperfusion
Method of measurement
By pulse oximetry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: There is one intervention group that includes COVID-19 patients admitted with severe symptoms who are resistant to common medical treatments. These patients will undergo hemoperfusion in 2 sessions and then the patients' paraclinical findings and vital signs will be evaluated.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital Urmia
Full name of responsible person
Saman Farshid
Street address
Imam Khomeini hospital , Erash blvd , Urmia
City
Urmia
Province
West Azarbaijan
Postal code
57157-81351
Phone
+98 44 3346 9931
Email
samanf63@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
ِDr Iraj Mohebi
Street address
Urmia University of Medical Sciences, Resalat Blvd-Emergency Alley, Urmia, ٌWest Azarbaijan
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3223 4896
Email
mohebbi_iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Saman Farshid
Position
Assitant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Imam Khomeini hospital , Erashad Blvd, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
57157-81351
Phone
+98 44 3346 9931
Email
samanf63@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saman Farshid
Position
Assitant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Imam Khomeini hospital , Erashad Blvd, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
57157-81351
Phone
+98 44 3346 9931
Email
samanf63@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saman Farshid
Position
Assitant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Imam Khomeini Hospital, Ershad Blvd,Urmia
City
Urmia
Province
West Azarbaijan
Postal code
57157-81351
Phone
+98 44 3346 9931
Email
samanf63@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
Patients data will be shared based on codes assigned to patients
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
University Faculty Members
Under which criteria data/document could be used
for research purposes
From where data/document is obtainable
sending an email to Dr Saman Farshid samanf63@gmail.com
What processes are involved for a request to access data/document
One week after sending the email and checking the purpose of the request
Comments
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