Protocol summary
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Study aim
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Determining effect of Convalescent Plasma on COVID-19 patients Outcome: A Randomised Clinical Trial
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Design
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The clinical trial has an intervention group without blinding and randomization
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU
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Main outcome variables
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1- 10-day mortality
2- 30-day mortality
3. Inflammatory factors
4- PaO2 / FiO2
General information
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Reason for update
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A change in English title
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Acronym
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COVID 19
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IRCT registration information
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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
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Registration date
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2020-03-24, 1399/01/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-03-28, 1399/01/09
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Expected recruitment end date
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2020-05-20, 1399/02/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
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Public title
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Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 30 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-23, 1399/01/04
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Ethics committee reference number
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IR.MAZUMS.REC.1399.7330
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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B34.2
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ICD-10 code description
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Coronavirus infection, unspecified
Primary outcomes
1
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Description
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Mortality
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Timepoint
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10 days and 30 days after intervention
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Method of measurement
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Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
2
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Description
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Inflammatory factors
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Timepoint
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Days 1, 3 and 7
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Method of measurement
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The enzyme-linked immunosorbent assay
3
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Description
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Partial pressure of arterial oxygen/Percentage of inspired oxygen
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Timepoint
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Days 1, 3, 7
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Method of measurement
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Partial pressure of arterial oxygen/Percentage of inspired oxygen
Secondary outcomes
1
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Description
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Length of hospitalization
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Timepoint
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End of study
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Method of measurement
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Day number
2
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Description
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Days of mechanical ventilation
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Timepoint
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End of study
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Method of measurement
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Day number
3
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Description
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Leukocyte and lymphocyte count
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Timepoint
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Days 1, 3, 7
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Method of measurement
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Complete blood count test
4
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Description
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CD3, CD4, CD8 cell count and CD4 / CD8 ratio
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Timepoint
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Days 1, 3, 7
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Method of measurement
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Flow Cytometry
5
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Description
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Function and changes of liver enzymes
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Timepoint
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Days 1, 3, 7
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Method of measurement
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Biochemical tests
6
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Description
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Cardiac enzyme function and changes
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Timepoint
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Days 1, 3, 7
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Method of measurement
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Biochemical tests
7
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Description
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Specific IgG
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Timepoint
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Days 1, 3, 7
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Method of measurement
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The enzyme-linked immunosorbent assay
8
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Description
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Radiological findings
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Timepoint
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Admitted time and day 14
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Method of measurement
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Computed tomography Scan and Chest X-Ray
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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SPSS data can be shared.
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When the data will become available and for how long
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Post publication
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To whom data/document is available
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Researcher
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Under which criteria data/document could be used
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Use for review study
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From where data/document is obtainable
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Corresponding author email
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What processes are involved for a request to access data/document
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Request via email
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Comments
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