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Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial

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History
# Registration date Revision Id
2 2020-03-30, 1399/01/11 129232
1 2020-03-24, 1399/01/05 126502
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  • Protocol summary

    Intensive care unit of Imam Khomeini hospital of Sari City
    After the call for the donation of the convalescent plasma by the recently recovered patients, about 450 ml of the received plasma will be transferred to the COVID-19 patients hospitalized in the ICU of Imam Khomeini Hospital in Sari.
    بخش ICU بیمارستان امام خمینی شهر ساری
    پس از فراخوان جهت اهدای پلاسمای بهبود یافته توسط بیمارانی که اخیرا بهبود یافته اند، حدود 450 میلی لیتر پلاسمای دریافت شده به بیماران کووید 19 بستری در بخش ICU بیمارستان امام خمینی شهر ساری انتقال داده می شود.

  • General information

    CPCOVID
    COVID 19
    empty
    A change in English title
    empty
    تغییر در عنوان انگلیسی
    Investigating effect of Convalescent Plasma on COVID-19 patients Outcome: A Randomised Clinical Trial
    Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
    Investigating effect of Convalescent Plasma on COVID-19 patients Outcome: A Randomised Clinical Trial
    Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial

  • Intervention groups

    #1
    Intervention group: COVID-19 Patients
    Intervention group: COVID-19 patients who are hospitalized in the ICU, according to the blood type, receive about 450 ml of plasma received from COVID-19 patients who have recently recovered.
    گروه مداخله: بیماران مبتلا به کروناویروس 19
    گروه مداخله: بیماران مبتلا به کووید 19 که در ICU بستری هستند، با مطابقت گروه خونی، حدود 450 میلی لیتر پلاسمای دریافت شده از بیماران کووید 19 که اخیرا بهبود پیدا کرده اند دریافت می کنند.

  • Sponsors / Funding sources

    #1
    Sari University of Medical Sciences
    Mazandaran University of Medical Sciences
    دانشگاه علوم پزشکی ساری
    دانشگاه علوم پزشکی مازندران

Protocol summary

Study aim
Determining effect of Convalescent Plasma on COVID-19 patients Outcome: A Randomised Clinical Trial
Design
The clinical trial has an intervention group without blinding and randomization
Settings and conduct
After the call for the donation of the convalescent plasma by the recently recovered patients, about 450 ml of the received plasma will be transferred to the COVID-19 patients hospitalized in the ICU of Imam Khomeini Hospital in Sari.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Recipient: 1- COVID-19 Patients 2- Consent to attend the study 3. Age 30 to 70 years 4- Don't be intubated 5- PaO2 / FiO2 is above 200 or Spo2 is greater than 85%. Donator: 1- Complete recovery from severe COVID-19 disease and hospital discharge 2- Consent to donate blood to the infected person 3- Age 30 to 60 years 4- Has normal CBC test results 5. Negative COVID-19 RT-PCR test Exclusion criteria: Recipient: 1. A history of hypersensitivity to blood transfusions or its products 2. History of IgA deficiency 3. Heart failure or any other factor that prevents the injection of of 500 ml plasma 4. Entering the intubation stage Donator: 1- Patients infected with blood-borne viral / infectious diseases 2 - Underlying heart disease, low or high blood pressure, diabetes, epilepsy, and anything that may prohibit blood donation. 3. Use of banned drugs for blood donation (eg, ethertinate, acitretin, aliotretinoin, isotretinoin, antiandrogens, NSAIDs, etc.) 4- Use of different drugs 5. Other prohibited donations based on blood transfusion standards
Intervention groups
Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU
Main outcome variables
1- 10-day mortality 2- 30-day mortality 3. Inflammatory factors 4- PaO2 / FiO2

General information

Reason for update
A change in English title
Acronym
COVID 19
IRCT registration information
IRCT registration number: IRCT20181104041551N1
Registration date: 2020-03-24, 1399/01/05
Registration timing: prospective

Last update: 2020-04-12, 1399/01/24
Update count: 1
Registration date
2020-03-24, 1399/01/05
Registrant information
Name
Fateme Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
f.heydari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-28, 1399/01/09
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
Public title
Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 Patients Consent to attend the study Do not be intubated PaO2 / FiO2 above 200 or Spo2 above 85%
Exclusion criteria:
A history of hypersensitivity to blood transfusions or its products History of IgA deficiency Heart failure or any factor that prevent from getting 500ml of plasma Entering the intubation stage
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vice-Chancellor for research, Mazandaran University of Medical Sciences, Moallem Sq.
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2020-03-23, 1399/01/04
Ethics committee reference number
IR.MAZUMS.REC.1399.7330

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Mortality
Timepoint
10 days and 30 days after intervention
Method of measurement
Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.

2

Description
Inflammatory factors
Timepoint
Days 1, 3 and 7
Method of measurement
The enzyme-linked immunosorbent assay

3

Description
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Timepoint
Days 1, 3, 7
Method of measurement
Partial pressure of arterial oxygen/Percentage of inspired oxygen

Secondary outcomes

1

Description
Length of hospitalization
Timepoint
End of study
Method of measurement
Day number

2

Description
Days of mechanical ventilation
Timepoint
End of study
Method of measurement
Day number

3

Description
Leukocyte and lymphocyte count
Timepoint
Days 1, 3, 7
Method of measurement
Complete blood count test

4

Description
CD3, CD4, CD8 cell count and CD4 / CD8 ratio
Timepoint
Days 1, 3, 7
Method of measurement
Flow Cytometry

5

Description
Function and changes of liver enzymes
Timepoint
Days 1, 3, 7
Method of measurement
Biochemical tests

6

Description
Cardiac enzyme function and changes
Timepoint
Days 1, 3, 7
Method of measurement
Biochemical tests

7

Description
Specific IgG
Timepoint
Days 1, 3, 7
Method of measurement
The enzyme-linked immunosorbent assay

8

Description
Radiological findings
Timepoint
Admitted time and day 14
Method of measurement
Computed tomography Scan and Chest X-Ray

Intervention groups

1

Description
Intervention group: COVID-19 patients who are hospitalized in the ICU, according to the blood type, receive about 450 ml of plasma received from COVID-19 patients who have recently recovered.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Educational Hospital, Sari
Full name of responsible person
Fatemeh Heidari
Street address
Imam Khomeini Educational Hospital, Razi St.
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
F.Heydari@mazums.ac.ir
Web page address
http://imamhospital.mazums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Professor Majid Saeedi
Street address
Vice-Chancellor for research, Mazandaran University of Medical Sciences, Moallem Sq.
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3448 4800
Email
msaeedi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Heidari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Educational Hospital, Razi Sq.
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
F.Heydari@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Heidari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Razi Sq.
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
011 3361700
Email
F.Heydari@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Heidari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Razi Sq.
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
F.Heydari@mazums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Not applicable
Title and more details about the data/document
SPSS data can be shared.
When the data will become available and for how long
Post publication
To whom data/document is available
Researcher
Under which criteria data/document could be used
Use for review study
From where data/document is obtainable
Corresponding author email
What processes are involved for a request to access data/document
Request via email
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