Back to resultsInvestigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
Primary Purpose
Coronavirus Infections
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Convalescent Plasma
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus Infections focused on measuring Coronavirus, COVID-19, SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2
Eligibility Criteria
Inclusion Criteria:
Recipient:
- COVID-19 Patients
- Consent to attend the study
- Age 30 to 70 years
- Don't be intubated
- PaO2 / FiO2 is above 200 or Spo2 is greater than 85%.
Donator:
- Complete recovery from severe COVID-19 disease and hospital discharge
- Consent to donate blood to the infected person
- Age 30 to 60 years
- Has normal CBC test results
- Negative COVID-19 RT-PCR test
Exclusion Criteria:
Recipient:
- A history of hypersensitivity to blood transfusions or its products
- History of IgA deficiency
- Heart failure or any other factor that prevents the transmission of of 500 ml plasma
- Entering the intubation stage
Donator:
- Patients infected with blood-borne viral / infectious diseases
- Underlying heart disease, low or high blood pressure, diabetes, epilepsy, and anything that may prohibit blood donation.
- Use of banned drugs for blood donation (eg, ethertinate, acitretin, aliotretinoin, isotretinoin, antiandrogens, NSAIDs, etc.)
- Use of different drugs
- Other prohibited donations based on blood transfusion standards
Sites / Locations
- Imam Khomeini Hospital, Mazandaran University of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
COVID-19 Patients
Arm Description
Outcomes
Primary Outcome Measures
Mortality changes in day 10
Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
Mortality changes in day 30
Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
Changes of C-reactive protein
Measurement of CRP
Changes of C-reactive protein
Measurement of CRP
Changes of C-reactive protein
Measurement of CRP
Changes of Interleukin 6
Measurement of IL-6
Changes of Interleukin 6
Measurement of IL-6
Changes of Interleukin 6
Measurement of IL-6
Changes of tumor necrosis factor-α
Measurement of TNF-α
Changes of tumor necrosis factor-α
Measurement of TNF-α
Changes of tumor necrosis factor-α
Measurement of TNF-α
Changes of PaO2/FiO2 Ratio
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Changes of PaO2/FiO2 Ratio
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Changes of PaO2/FiO2 Ratio
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Secondary Outcome Measures
Changes of CD3
Changes of CD3
Changes of CD3
Changes of CD4
Changes of CD4
Changes of CD4
Changes of CD8
Changes of CD8
Changes of CD8
Changes of CD4/CD8 ratio
Changes of CD4/CD8 ratio
Changes of CD4/CD8 ratio
Changes of lymphocyte count
Changes of lymphocyte count
Changes of lymphocyte count
Changes of leukocyte count
Changes of leukocyte count
Changes of leukocyte count
Changes of alanine transaminase (ALT)
Changes of alanine transaminase (ALT)
Changes of alanine transaminase (ALT)
Changes of aspartate transaminase (AST)
Changes of aspartate transaminase (AST)
Changes of aspartate transaminase (AST)
Changes of alkaline phosphatase (ALP)
Changes of alkaline phosphatase (ALP)
Changes of alkaline phosphatase (ALP)
Changes of lactate dehydrogenase (LDH)
Changes of lactate dehydrogenase (LDH)
Changes of lactate dehydrogenase (LDH)
Changes of creatine phosphokinase (CPK)
Changes of creatine phosphokinase (CPK)
Changes of creatine phosphokinase (CPK)
Changes of Creatine kinase-MB (CK-MB)
Changes of Creatine kinase-MB (CK-MB)
Changes of Creatine kinase-MB (CK-MB)
Changes of Specific IgG
Changes of Specific IgG
Changes of Specific IgG
Radiological findings
Computed tomography Scan and Chest X-Ray
Radiological findings
Computed tomography Scan and Chest X-Ray
Number of days ventilated
Length of hospitalization
Full Information
NCT ID
NCT04327349
First Posted
March 24, 2020
Last Updated
March 30, 2020
Sponsor
Mazandaran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04327349
Brief Title
Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
Official Title
Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2020 (Anticipated)
Primary Completion Date
May 20, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mazandaran University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Coronavirus disease 2019 (COVID-19) was recognized as a pandemic on March 11, 2020 by the World Health Organization. The virus that causes COVID-19 (SARS-CoV-2) is easily transmitted through person to person and there is still no specific approach against the disease and mortality rate in severe cases is also significant. Therefore, finding effective treatment for the mortality of these patients is very important. In this study the investigators aim to determine the effect of Convalescent Plasma on COVID-19 patients Outcome through a Clinical Trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infections
Keywords
Coronavirus, COVID-19, SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
COVID-19 Patients
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Convalescent Plasma
Intervention Description
Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU
Primary Outcome Measure Information:
Title
Mortality changes in day 10
Description
Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
Time Frame
10 days after plasma transmission
Title
Mortality changes in day 30
Description
Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
Time Frame
30 days after plasma transmission
Title
Changes of C-reactive protein
Description
Measurement of CRP
Time Frame
Day 1
Title
Changes of C-reactive protein
Description
Measurement of CRP
Time Frame
Day 3
Title
Changes of C-reactive protein
Description
Measurement of CRP
Time Frame
Day 7
Title
Changes of Interleukin 6
Description
Measurement of IL-6
Time Frame
Day 1
Title
Changes of Interleukin 6
Description
Measurement of IL-6
Time Frame
Day 3
Title
Changes of Interleukin 6
Description
Measurement of IL-6
Time Frame
Day 7
Title
Changes of tumor necrosis factor-α
Description
Measurement of TNF-α
Time Frame
Day 1
Title
Changes of tumor necrosis factor-α
Description
Measurement of TNF-α
Time Frame
Day 3
Title
Changes of tumor necrosis factor-α
Description
Measurement of TNF-α
Time Frame
Day 7
Title
Changes of PaO2/FiO2 Ratio
Description
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Time Frame
Day 1
Title
Changes of PaO2/FiO2 Ratio
Description
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Time Frame
Day 3
Title
Changes of PaO2/FiO2 Ratio
Description
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Changes of CD3
Time Frame
Day 1
Title
Changes of CD3
Time Frame
Day 3
Title
Changes of CD3
Time Frame
Day 7
Title
Changes of CD4
Time Frame
Day 1
Title
Changes of CD4
Time Frame
Day 3
Title
Changes of CD4
Time Frame
Day 7
Title
Changes of CD8
Time Frame
Day 1
Title
Changes of CD8
Time Frame
Day 3
Title
Changes of CD8
Time Frame
Day 7
Title
Changes of CD4/CD8 ratio
Time Frame
Day 1
Title
Changes of CD4/CD8 ratio
Time Frame
Day 3
Title
Changes of CD4/CD8 ratio
Time Frame
Day 7
Title
Changes of lymphocyte count
Time Frame
Day 1
Title
Changes of lymphocyte count
Time Frame
Day 3
Title
Changes of lymphocyte count
Time Frame
Day 7
Title
Changes of leukocyte count
Time Frame
Day 1
Title
Changes of leukocyte count
Time Frame
Day 3
Title
Changes of leukocyte count
Time Frame
Day 7
Title
Changes of alanine transaminase (ALT)
Time Frame
Day 1
Title
Changes of alanine transaminase (ALT)
Time Frame
Day 3
Title
Changes of alanine transaminase (ALT)
Time Frame
Day 7
Title
Changes of aspartate transaminase (AST)
Time Frame
Day 1
Title
Changes of aspartate transaminase (AST)
Time Frame
Day 3
Title
Changes of aspartate transaminase (AST)
Time Frame
Day 7
Title
Changes of alkaline phosphatase (ALP)
Time Frame
Day 1
Title
Changes of alkaline phosphatase (ALP)
Time Frame
Day 3
Title
Changes of alkaline phosphatase (ALP)
Time Frame
Day 7
Title
Changes of lactate dehydrogenase (LDH)
Time Frame
Day 1
Title
Changes of lactate dehydrogenase (LDH)
Time Frame
Day 3
Title
Changes of lactate dehydrogenase (LDH)
Time Frame
Day 7
Title
Changes of creatine phosphokinase (CPK)
Time Frame
Day 1
Title
Changes of creatine phosphokinase (CPK)
Time Frame
Day 3
Title
Changes of creatine phosphokinase (CPK)
Time Frame
Day 7
Title
Changes of Creatine kinase-MB (CK-MB)
Time Frame
Day 1
Title
Changes of Creatine kinase-MB (CK-MB)
Time Frame
Day 3
Title
Changes of Creatine kinase-MB (CK-MB)
Time Frame
Day 7
Title
Changes of Specific IgG
Time Frame
Day 1
Title
Changes of Specific IgG
Time Frame
Day 3
Title
Changes of Specific IgG
Time Frame
Day 7
Title
Radiological findings
Description
Computed tomography Scan and Chest X-Ray
Time Frame
Within 2 hours after admission
Title
Radiological findings
Description
Computed tomography Scan and Chest X-Ray
Time Frame
Day 14
Title
Number of days ventilated
Time Frame
Through study completion, an average of 2 weeks
Title
Length of hospitalization
Time Frame
Through study completion, an average of 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recipient:
COVID-19 Patients
Consent to attend the study
Age 30 to 70 years
Don't be intubated
PaO2 / FiO2 is above 200 or Spo2 is greater than 85%.
Donator:
Complete recovery from severe COVID-19 disease and hospital discharge
Consent to donate blood to the infected person
Age 30 to 60 years
Has normal CBC test results
Negative COVID-19 RT-PCR test
Exclusion Criteria:
Recipient:
A history of hypersensitivity to blood transfusions or its products
History of IgA deficiency
Heart failure or any other factor that prevents the transmission of of 500 ml plasma
Entering the intubation stage
Donator:
Patients infected with blood-borne viral / infectious diseases
Underlying heart disease, low or high blood pressure, diabetes, epilepsy, and anything that may prohibit blood donation.
Use of banned drugs for blood donation (eg, ethertinate, acitretin, aliotretinoin, isotretinoin, antiandrogens, NSAIDs, etc.)
Use of different drugs
Other prohibited donations based on blood transfusion standards
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Majid Saeedi, Ph.D.
Organizational Affiliation
Vice-Chancellor for Research, Mazandaran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Imam Khomeini Hospital, Mazandaran University of Medical Sciences
City
Sari
State/Province
Mazandaran
ZIP/Postal Code
4816633131
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
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