Determining the effectiveness of hemoperfusion in patients with COVID-19 disease in Hajar Hospital in Shahrekord
Design
Patients undergo hemoperfusion. Clinical signs and CT scans of the lungs are recorded continuously before and after hemoperfusion. And improvement of clinical findings and CT findings of the patient are evaluated. Each patient may need at least three hemoperfusions. Each perfusion period lasts about 4 hours.
Settings and conduct
ICU ward of Hajar Hospital in Shahrekord
Patients undergo hemoperfusion. Clinical signs and CT scans of the lungs are recorded continuously before and after hemoperfusion. And improvement of clinical findings and CT findings of the patient are evaluated. Each patient may need at least three hemoperfusions. Each perfusion period lasts about 4 hours.
Participants/Inclusion and exclusion criteria
Patients with severe progressive pulmonary involvement
Have a positive PCR test
Patients who are currently under mechanical ventilation or will need it in the near future.
Intervention groups
Patients with COVID-19 undergo hemoperfusion.
Main outcome variables
Mortality rate, reduction of hospitalization days, CT scan indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210718051922N1
Registration date:2021-08-06, 1400/05/15
Registration timing:registered_while_recruiting
Last update:2021-08-06, 1400/05/15
Update count:0
Registration date
2021-08-06, 1400/05/15
Registrant information
Name
Ahmad Raesi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
raesi.a@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-27, 1400/05/05
Expected recruitment end date
2021-10-27, 1400/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of Hemoperfusion in patients with COVID-19 in Hajar hospital, shahrekord
Public title
Hemoperfusion in Covid 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe progressive pulmonary involvement
Have a positive PCR test
Patients who are currently under mechanical ventilation or will need it in the near future.
Exclusion criteria:
Patients with shock symptoms
Patients with multiple organ failure
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Shahrekord University of Medical Sciences
Street address
Parastar Aven.Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.SKUMS.REC.1399.030
Health conditions studied
1
Description of health condition studied
COVID19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Mortality
Timepoint
End of study
Method of measurement
Patient file
2
Description
Number of hospitalization days
Timepoint
End of study
Method of measurement
Patient file
3
Description
CT scan indexes
Timepoint
Before the start of the study and the first day after hemoperfusion
Method of measurement
CT scan of the patient
Secondary outcomes
1
Description
Temperature
Timepoint
Days 1, 3, 7 and 12
Method of measurement
Thermometer
2
Description
O2 sat
Timepoint
Days 1, 3, 7 and 12
Method of measurement
Pulse oximetry
3
Description
WBC
Timepoint
Days 1, 3, 7 and 12
Method of measurement
Blood test
4
Description
Lym
Timepoint
Days 1, 3, 7 and 12
Method of measurement
Blood test
5
Description
Ferritin
Timepoint
Days 1, 3, 7 and 12
Method of measurement
Blood test
6
Description
Ast, Alt , Alkp
Timepoint
Days 1, 3, 7 and 12
Method of measurement
Blood test
7
Description
Mechanical ventilation
Timepoint
Before the intervention and the first dose after hemoperfusion
Method of measurement
Patient prognosis
Intervention groups
1
Description
Intervention group: Patients with COVID-19 undergo hemoperfusion.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital, Shahrekord
Full name of responsible person
Ahmad Raesi
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
raesi.a@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghy
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
raesi.a@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Ahmad Raesi
Position
Internal specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Parastar aven
City
Sahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
raesi.a@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ahmad Raesi
Position
Internal specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Parastar aven
City
Sahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
raesi.a@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ahmad Raesi
Position
Internal specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Parastar aven
City
Sahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
raesi.a@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
2022-2023
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
I have not decided yet
From where data/document is obtainable
I have not decided yet
What processes are involved for a request to access data/document