Considering the role of inflammatory cytokines in COVID-19 disease and its severity, this study was designed to evaluate the effectiveness of hemoperfusion that can remove inflammatory cytokines from the blood.
Design
This clinical trial will be conducted with one intervention group, with no control group and no blindness on 10 hospitalized patients with severe forms of COVID-19.
Settings and conduct
This clinical trial will be conducted with one intervention group, with no control group and no blindness on 10 hospitalized patients admitted in Ayatollah Rouhani Hospital in Babol, Mazandaran with severe forms of COVID-19 who no improvement was observed in their disease course despite receiving different treatments.
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 polymerase chain reaction and the physician´s diagnosis; Patients who have PaO2 less than 60; Patients who have PaO2/FiO2 less than 200; Patients who have PaCo2 more than 50; SpO2 less than 88%, and no improvement has been achieved despite 48 hours of non-invasive respiratory therapy.
Exclusion Criteria: Plasma platelets count less than 30000 per microliter; Multiple organ failure
Intervention groups
Intervention Group: Patients undergo extracorporeal blood purification on three sessions. Each session conducts in six hours per day, using hemoperfusion filters. The second course of hemoperfusion is performed 12-24 hours after the first and the third session 24 hours after the second time.
Control Group: Since the patients with severe coronavirus disease (COVID-19) have been enrolled in the study, no control group is considered.
Main outcome variables
Improving the general condition of the patient
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150704023055N2
Registration date:2020-04-03, 1399/01/15
Registration timing:retrospective
Last update:2020-04-03, 1399/01/15
Update count:0
Registration date
2020-04-03, 1399/01/15
Registrant information
Name
Simin Mouodi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0624
Email address
s.mouodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-24, 1399/01/05
Expected recruitment end date
2020-04-03, 1399/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effectiveness of hemoperfusion in patients with severe coronavirus disease 2019 (COVID-19)
Public title
Hemoperfusion in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diagnosis of COVID-19 based on the clinical manifestations, lung CT-scan, testing of pharyngeal sample using real-time polymerase chain reaction and the physician´s diagnosis
Patients who have partial pressure of oxygen in alveoli (PaO2) less than 60, even after different methods of oxygen-therapy
Patients who have partial pressure of oxygen in alveoli to the fraction of inspired oxygen (PaO2/FiO2) less than 200
Patients who have partial pressure of carbon dioxide in alveoli (PaCo2) more than 50; PH less than 7.35; peripheral capillary oxygen saturation (SpO2) less than 88%; and no improvement has been achieved despite 48 hours of non-invasive respiratory therapy
Exclusion criteria:
Plasma platelet count less than 30000 per microliter
Multiple organ dysfunction
Age
From 18 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
Ethics Committee of Babol University of Medical Sciences
Street address
Ganjafrooz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4136747176
Approval date
2020-03-24, 1399/01/05
Ethics committee reference number
IR.MUBABOL.HRI.REC.1399.038
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
U07.1: COVID-19, virus identified
2
Description of health condition studied
COVID-19
ICD-10 code
U07.2
ICD-10 code description
U07.2: COVID-19, virus not identified
Primary outcomes
1
Description
Improving the general condition of the patient
Timepoint
Before intervention and one week after the third session of hemoperfusion
Method of measurement
No need to receive any intensive respiratory care in the patient
Secondary outcomes
1
Description
Serum level of interleukin- 6
Timepoint
Before the first and after the third session of hemoperfusion
Method of measurement
To test the blood sample
Intervention groups
1
Description
Intervention group: Patients undergo extracorporeal blood purification on three sessions. Each session conducts in six hours per day, using hemoperfusion filters (HA280 and HA230) manufactured by the Jafron Company, China. The second course of hemoperfusion is performed 12-24 hours after the first and the third session 24 hours after the second time.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Masoumeh Asgharpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Ganjafrooz avenue, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
masi9932002@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Masoumeh Asgharpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Ganjafrooz avenue, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
masi9932002@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Simin Mouodi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Research in clinical sciences
Street address
Ganjafrooz Avenue, Babol University of Medical Sciences, Babol
City
Babol
Province
Mazandaran
Postal code
4136747176
Phone
+98 11 3219 4720
Fax
+98 11 3219 7667
Email
dr.mouodi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Information on the clinical features of patients, without mentioning their individual characteristics, will be published through the final report of the study.
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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
Information on the clinical features of patients, without mentioning their individual characteristics, will be published through the final report of the study.
When the data will become available and for how long
Following the release of the final project report, after receiving an email from academic researchers, the questions will be answered within a maximum of two weeks.
To whom data/document is available
Academic researches
Under which criteria data/document could be used
After receiving an email from academic researchers
From where data/document is obtainable
Dr Masoumeh Asgharpour
What processes are involved for a request to access data/document
The questions will be answered within a maximum of two weeks after receiving the email.