The effect of red blood cell exchange on hypoxemia in COVID-19 patients
Design
A double-blind non-randomized phase 3 clinical trial with the control group
Settings and conduct
In patients with severe COVID-19, despite normal RBC counts, there is dysfunction in oxygen transfer due to the deformation and structure of RBCs. This study is performed as a non-randomized double-blind clinical trial to investigate the effect of RBC replacement on improving oxygenation and increasing the survival rate of patients with severe COVID-19 in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Positive PCR test for COVID-19; ground glass opacity more than 50% in CT scan; RR>30; severe hypoxemia and O2 sat<80%; progressive hypoxemia and intubation in 24 h; presence of at least one risk factor for severe COVID-19 such as BMI>30, DM, pulmonary disease, immune deficiency.
Exclusion criteria: death in 24 hours after admission; transferring to another hospital during treatment; pregnancy.
Intervention groups
The intervention group received standard treatment and RBC exchange. After determining the blood group and crossmatch, first, a single unit blood sampling equal to 250-300 cc is performed and a unit pack cell is transfused and this process is repeated up to 4 times.
The control group received only standard treatment.
Main outcome variables
O2 saturation to more than 90% in the room; mortality rate
General information
Reason for update
Acronym
BEC
IRCT registration information
IRCT registration number:IRCT20160316027081N2
Registration date:2021-05-13, 1400/02/23
Registration timing:registered_while_recruiting
Last update:2021-05-13, 1400/02/23
Update count:0
Registration date
2021-05-13, 1400/02/23
Registrant information
Name
Saeed Soleiman-Meigooni
Name of organization / entity
AJA university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4414 4939
Email address
s.s.meigooni@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of red blood cell exchange on hypoxemia in patients with severe COVID-19
Public title
Blood exchange in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive PCR test for COVID-19
Ground glass opacity more than 50% in CT scan
RR>30
Severe hypoxemia and O2 sat<80%
Progressive hypoxemia and intubation in 24 h
Presence of at least one risk factor for severe Covid-19 such as BMI>30, DM, Pulmonary disease, Immune deficiency
Exclusion criteria:
Death in 24 hours after admission
Transferring to another hospital during treatment
Pregnancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher does not know which patients agree to have a red blood cell exchange.
The person who analyzes the information and prepares the draft article.
Placebo
Not used
Assignment
Parallel
Other design features
This study is conducted for the first time in Iran.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Aja university of medical sciences
Street address
E'temadzadeh, Fatemi
City
Tehran
Province
Tehran
Postal code
1487784637
Approval date
2020-06-06, 1399/03/17
Ethics committee reference number
IR.AJAUMS.REC.1399.054
Health conditions studied
1
Description of health condition studied
Pneumonia due to COVID-19
ICD-10 code
U07.1
ICD-10 code description
Pneumonia due to coronavirus disease 2019
Primary outcomes
1
Description
Increasing O2 saturation more than 90%
Timepoint
The day 7 and 14
Method of measurement
Pulse oximetry in the room air
Secondary outcomes
1
Description
Mortality rate
Timepoint
The days 7, 14, 28
Method of measurement
Yes/ No
Intervention groups
1
Description
Intervention group: after determining the blood group and crossmatch, first a single unit blood sampling equal to 250-300 cc is performed and a unit pack cell is transfused and this process is repeated up to 4 times. The whole process takes two days and the distance from one turn to the next is 12 hours.
Category
Treatment - Other
2
Description
Control group: The control group receives only the standard treatment protocol of severe pneumonia of COVID-19 in accordance with the latest guideline of the Ministry of Health.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Be'sat hospital
Full name of responsible person
Mohammad Aminianfar
Street address
Hejrat St, Basij Blvd, Afsarieh
City
Tehran
Province
Tehran
Postal code
1781997511
Phone
+98 21 3995 5555
Email
maminianfar@yahoo.com
2
Recruitment center
Name of recruitment center
Khanevadeh hospital
Full name of responsible person
Saeed Soleiman-Meigooni
Street address
Kaaj St, Shari'ati Blvd
City
Tehran
Province
Tehran
Postal code
1613917149
Phone
+98 21 7760 0500
Email
dr.saeed.meigooni@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zoshk
Street address
E'temad Zadeh Av, Fatemi St
City
Tehran
Province
Tehran
Postal code
1411718701
Phone
+98 21 8609 6350
Email
admin@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Mohammad Aminianfar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Hejrat St, Basij Blvd, Afsarieh
City
Tehran
Province
Tehran
Postal code
1781997511
Phone
+98 21 3995 5555
Email
maminianfar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohammad Aminianfar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Hejrat St, Basij Blvd, Afsarieh
City
Tehran
Province
Tehran
Postal code
1781997511
Phone
+98 21 3995 5555
Email
maminianfar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohammad Aminianfar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Hejrat St, Basij Blvd, Afsarieh
City
Tehran
Province
Tehran
Postal code
1781997511
Phone
+98 21 3995 5555
Email
maminianfar@yahoo.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
Specific participant data sets are to be shared
When the data will become available and for how long
Six months after publishing the data
To whom data/document is available
Deputy of research, Ministry of health
Under which criteria data/document could be used
After formal request
From where data/document is obtainable
AJA University of medical sciences, deputy of research
What processes are involved for a request to access data/document
From Ministry of Health, Deputy of Research To AJA University of Medical Sciences