Convalescent plasma of COVID-19 patients is effective for respiratory failure of these patients
Design
In 30 patients with confirmed COVID-19 with respiratory failure or ARDS, in addition to all antiviral and supportive treatments, 200-400 cc of convalescent plasma will be transfused.Improvement in SOFA score, oxygenation, P/F ratio, end organs failure and fever will be monitored.
Settings and conduct
After ABO compatibility of patient and donor, 200-250 cc of convalescent plasma will be transfused on the same that is prepared.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
1. Age over 18 years old
2. Proven laboratory COVID-19 disease and positive PCR
3. Existence of severe bilateral pneumonia in CT scan or chest x-ray
4. Pao2/fio2<300
5. Oxygen therapy or mechanical ventilation.
Exclusion criteria:
1. blood group incompatibility
2. pregnancy
Intervention groups
COVID-19 patients treated with convalescent Plasma
Main outcome variables
1. Convalescent plasma transfusion
2. P / F
3. Blood pressure
4. Kidney dysfunction
5. Blood disorders
6. consciousness
7. SOFA score
8. Mechanical ventilation duration
9. Duration of hospitalization
10. Hospital death
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200406046968N2
Registration date:2020-04-22, 1399/02/03
Registration timing:prospective
Last update:2020-04-22, 1399/02/03
Update count:0
Registration date
2020-04-22, 1399/02/03
Registrant information
Name
Haleh Mikaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3329 6024
Email address
halehmikaeili@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of convalescent plasma transfusion of COVID-19 survivors on the treatment of respiratory failure of these patients
Public title
Efficacy of convalescent plasma transfusion of COVID-19 survivors on the treatment of respiratory failure of these patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Confirmed COVID-19 clinically and positive PCR
Severe bilateral pulmonary involvement on CT scan or chest x-ray
Pao2/Fio2<300
Need for oxygen therapy or mechanical ventilation
Exclusion criteria:
Blood group incompatibility
Pregnancy
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Regional Research Ethics Committee (Humanities Studies)
Street address
3rd Floor, Central Building, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-04-13, 1399/01/25
Ethics committee reference number
IR.TBZMED.REC.1399.018
Health conditions studied
1
Description of health condition studied
COVID-19 Disease
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified site
Primary outcomes
1
Description
Effect of convalescent plasma
Timepoint
Blood and plasma will be taken from patients who have been symptom free for 14-17 days. If it is less than 14 days, the donor should have 2 negative tests in two different days.
Method of measurement
ELISA
Secondary outcomes
1
Description
Oxygenation
Timepoint
Daily until discharge or death
Method of measurement
ABG
2
Description
SOFA score
Timepoint
Daily until discharge or death
Method of measurement
Questionnaire
3
Description
Duration of mechanical ventilation
Timepoint
until discharge or death
Method of measurement
Questionnaire
4
Description
Duration of admission
Timepoint
Daily until discharge or death
Method of measurement
Questionnaire
5
Description
Mortality
Timepoint
Admission period
Method of measurement
patient's file
Intervention groups
1
Description
In 30 patients with respiratory failure and ARDS caused by COVID-19 undergoing mechanical ventilation or oxygen therapy, antivirals and supportive care therapies will be continued, and 200-400 cc of convalescent plasma will transfused for them.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Haleh Mikaeili
Street address
3rd Floor, Central Building, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7059
Email
info@imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khosro Adibkia
Street address
3rd Floor, Central Building, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz university of medical science
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
Haleh Mikaeili
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
3rd Floor, Central Building, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5157679746
Phone
+98 41 3329 6024
Email
halehmikaeili@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Haleh Mikaeili
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
3rd Floor, Central Building, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5157679746
Phone
+98 41 3329 6024
Email
halehmikaeili@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Haleh Mikaeili
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
3rd Floor, Central Building, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5157679746
Phone
+98 41 3329 6024
Email
halehmikaeili@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
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
Conscious consent form
When the data will become available and for how long
1 month after printing the results
To whom data/document is available
Researchers and treatment staff
Under which criteria data/document could be used
In order to cure
From where data/document is obtainable
Mikaeili haleh
What processes are involved for a request to access data/document