To determine the effectiveness of hemoperfusion to remove cytokines-induced by COVID-19 in the blood
Design
A clinical trial, with one intervention group, with no control group, without blindness, ten patients with severe forms of COVID-19, Phase 2.
Settings and conduct
This study will be performed in Imam Reza Hospital, Tabriz, Iran. This clinical trial will be conducted on one intervention group, with no control group and no blindness on 10 hospitalized patients admitted with severe forms of COVID-19 and before intubation.CT scan of lungs, biochemical tests, hospitalization period, need to intubation and mortality rate will be assessed in this group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with severe cytokine storm and respiratory symptoms (ARDS); Patients with a respiratory rate of more than 30; PaO2/FiO2 less than 300 mm Hg; Age 18-65 year؛ immediate need for intubation. Exclusion criteria: advanced multi-organ failure; coagulation abnormality; other viral infection and bacterial sepsis; plasma platelets count less than 30000 per microliter.
Intervention groups
Intervention group: Patients undergo dialysis on 2 sessions 4 hours with hemoperfusion HA330 filter. The second course of hemoperfusion is performed 18-24 hours after the first session.
Main outcome variables
The change of pneumonia severity on CT scanning; ARDS symptoms; mortality rate; hospitalization period
General information
Reason for update
Acronym
HemoCov
IRCT registration information
IRCT registration number:IRCT20200317046797N5
Registration date:2020-04-19, 1399/01/31
Registration timing:prospective
Last update:2020-04-19, 1399/01/31
Update count:0
Registration date
2020-04-19, 1399/01/31
Registrant information
Name
Sepideh Zununi Vahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 9331
Email address
sepide.zununi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment of COVID-19-induced cytokine storm with filter hemoperfusion HA330
Public title
Treatment of COVID-19-induced cytokine storm by hemoperfusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive PCR for COVID-19
PaO2/FiO2 less than 200 mmHg
More than 50% involvement of pulmonary fields in CT scan
Respiratory rate more than 30/minute
Resting O2 saturation less than 90%
Exclusion criteria:
Coagulation abnormality
Plasma platelets count <30000/µL
Other viral infection and bacterial sepsis
Advanced multi-organ failure
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
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
Tabriz University of Medical Sciences
Street address
3th floor of Tabriz University of Medical Sciences Central Building, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-04-18, 1399/01/30
Ethics committee reference number
IR.TBZMED.REC.1399.024
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
2
Description of health condition studied
COVID-19-induced pneumonia
ICD-10 code
J12.81
ICD-10 code description
Pneumonia due to SARS-associated coronavirus
Primary outcomes
1
Description
The general condition of the patient
Timepoint
Before intervention and 1 day after final intervention
Method of measurement
Lung CT scan; No need to receive any intensive respiratory care in the patient
2
Description
Mortality rate
Timepoint
At baseline and discharge time or patient death
Method of measurement
Observation
3
Description
Need for intubation
Timepoint
Period of hospitalization
Method of measurement
Observation or reading of hospitalized documents
4
Description
Period of hospitalization
Timepoint
At baseline and discharge time
Method of measurement
Number of hospitalized days
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients undergo hemodialysis on 2 sessions, each session will be conducted in 4 hours using hemoperfusion HA330 filter (JAFRON BIOMEDICAL.CO.LTD, China). The second round will be performed 18-24 hours after the first time. Protocol: a blood flow 150cc/minute, Heparin 10-12 unit per kg per hour.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Immamreza Hospita of Tabriz
Full name of responsible person
Dr Bahram Niknafs
Street address
Imamreza Hospital, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
bahramniknafs@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Samiei
Street address
3th floor of Tabriz University of Medical Sciences Central Building, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Taghizadieh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Gholgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1335 2078
Email
alitaghizadieh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Ardalan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tabriz University of Medical Sciences, Golghasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 9331
Email
ardalan34@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sepideh Zununi Vahed
Position
Assistant Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Tabriz University of Medical Sciences, Gholghasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 9331
Email
sepide.zununi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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
Undecided - It is not yet known if there will be 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