Determination of therapeutic effects of hemoperfusion in intubated and non-intubated patients with respiratory failure caused by the COVID-19
Design
Clinical trial with one intervention group, with no control group and no blindness on 40 hospitalized patients with severe forms of COVID-19.
Settings and conduct
This nonrandomized with no blindness clinical trial will be performed in Loghman Hakim Hospital on patients after obtaining permission from the ethics committee on patients with respiratory failure caused by the COVOID-19, who are on antiviral medication according to national protocol. Patients will be divided into two groups; intubated and non-intubated. Intervention group will be treated with hemoperfusion. Laboratory and clinical finding will be evaluated. The data will be analyzed by SPSS software.
Participants/Inclusion and exclusion criteria
The participants are hospitalized patients with severe forms of COVID-19. Inclusion Criteria: Patients with diagnosis of COVID-19 based on the clinical manifestations, lung CT-scan, testing of pharyngeal sample using real-time PCR and the physician´s diagnosis; Patients who have SpO2 less than 85%, and no improvement has been achieved despite 48 hours of standard treatment.
Exclusion Criteria: Plasma platelets count less than 30000 per microliter; Multiple organ failure
Intervention groups
Intervention group: 40 eligible patients with severe COVID-19 in a 1:1 ratio: (20 intubated and 20 non-Intubated)hemoperfusion + Standard of care treatment
Main outcome variables
O2 Saturation
CRP
Ferritin
Vasopressor need
Length of hospital stay
Mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200608047686N2
Registration date:2020-11-19, 1399/08/29
Registration timing:registered_while_recruiting
Last update:2020-11-19, 1399/08/29
Update count:0
Registration date
2020-11-19, 1399/08/29
Registrant information
Name
Muhanna Kazempour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 7243
Email address
muhannakazempour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-17, 1399/07/26
Expected recruitment end date
2021-01-17, 1399/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of hemoperfusion in intubated and non-intubated patients with respiratory failure caused by the COVID-19
Public title
The role of hemoperfusion in COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized patients with respiratory failure caused by the COVID-19
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
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 Shahid beheshti University of Medical Sciences
Street address
Yaman St, Velenjak, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
19857-17443
Approval date
2020-10-13, 1399/07/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.582
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
O2 Saturation
Timepoint
Before and after the sessions of hemoperfusion
Method of measurement
Pulse Oximetry
2
Description
CRP
Timepoint
Before and after the sessions of hemoperfusion
Method of measurement
Blood level
3
Description
Ferritin
Timepoint
Before and after the sessions of hemoperfusion
Method of measurement
Blood level
4
Description
Vasopressor need
Timepoint
Before and after the sessions of hemoperfusion
Method of measurement
Observation
Secondary outcomes
1
Description
Lenght of hospitat stay
Timepoint
Daily up to discharge
Method of measurement
Days of hospitalization
2
Description
Mortality
Timepoint
Daily up to 28 days
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: 40 eligible patients with severe COVID-19 in a 1:1 ratio: (20 intubated and 20 non-intubated)hemoperfusion + Standard of care treatment
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Muhanna Kazempour
Street address
Loghman Hakim Hospital, Kamali Street, South Karegar Avenue
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 7243
Email
edulhmc@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Yaman St, Velenjak St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Muhanna Kazempour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Loghman Hakim Hospital, Kamali Ave, South Kargar St
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 9005
Email
muhannakazempour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Muhanna Kazempour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Loghman Hakim Hospital, Kamali Street, South Karegar Avenue
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 7243
Email
muhannakazempour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Muhanna Kazempour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Loghman Hakim Hospital, Kamali Street, South Karegar Avenue
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 7243
Email
muhannakazempour@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
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
Yes - There is 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
Title and more details about the data/document
At the time of publication
When the data will become available and for how long
At the time of publication
To whom data/document is available
Public
Under which criteria data/document could be used
They will be publically available.
From where data/document is obtainable
The study protocol, statistical analytic plan will be shared as supplementary material at the time of publication of results
What processes are involved for a request to access data/document
The study protocol, statistical analytic plan will be shared as supplementary material at the time of publication of results