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

Study Overview
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Brief Summary
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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

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

Conditions
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Coronavirus Infections

Intervention / Treatment
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* Biological: Convalescent Plasma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: COVID-19 Patients<br> | Biological: Convalescent Plasma<br>* Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 days after plasma transmission | 
| 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. | 30 days after plasma transmission | 
| Changes of C-reactive protein | Measurement of CRP | Day 1 | 
| Changes of C-reactive protein | Measurement of CRP | Day 3 | 
| Changes of C-reactive protein | Measurement of CRP | Day 7 | 
| Changes of Interleukin 6 | Measurement of IL-6 | Day 1 | 
| Changes of Interleukin 6 | Measurement of IL-6 | Day 3 | 
| Changes of Interleukin 6 | Measurement of IL-6 | Day 7 | 
| Changes of tumor necrosis factor-α | Measurement of TNF-α | Day 1 | 
| Changes of tumor necrosis factor-α | Measurement of TNF-α | Day 3 | 
| Changes of tumor necrosis factor-α | Measurement of TNF-α | Day 7 | 
| Changes of PaO2/FiO2 Ratio | Partial pressure of arterial oxygen/Percentage of inspired oxygen | Day 1 | 
| Changes of PaO2/FiO2 Ratio | Partial pressure of arterial oxygen/Percentage of inspired oxygen | Day 3 | 
| Changes of PaO2/FiO2 Ratio | Partial pressure of arterial oxygen/Percentage of inspired oxygen | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of CD3 |  | Day 1 | 
| Changes of CD3 |  | Day 3 | 
| Changes of CD3 |  | Day 7 | 
| Changes of CD4 |  | Day 1 | 
| Changes of CD4 |  | Day 3 | 
| Changes of CD4 |  | Day 7 | 
| Changes of CD8 |  | Day 1 | 
| Changes of CD8 |  | Day 3 | 
| Changes of CD8 |  | Day 7 | 
| Changes of CD4/CD8 ratio |  | Day 1 | 
| Changes of CD4/CD8 ratio |  | Day 3 | 
| Changes of CD4/CD8 ratio |  | Day 7 | 
| Changes of lymphocyte count |  | Day 1 | 
| Changes of lymphocyte count |  | Day 3 | 
| Changes of lymphocyte count |  | Day 7 | 
| Changes of leukocyte count |  | Day 1 | 
| Changes of leukocyte count |  | Day 3 | 
| Changes of leukocyte count |  | Day 7 | 
| Changes of alanine transaminase (ALT) |  | Day 1 | 
| Changes of alanine transaminase (ALT) |  | Day 3 | 
| Changes of alanine transaminase (ALT) |  | Day 7 | 
| Changes of aspartate transaminase (AST) |  | Day 1 | 
| Changes of aspartate transaminase (AST) |  | Day 3 | 
| Changes of aspartate transaminase (AST) |  | Day 7 | 
| Changes of alkaline phosphatase (ALP) |  | Day 1 | 
| Changes of alkaline phosphatase (ALP) |  | Day 3 | 
| Changes of alkaline phosphatase (ALP) |  | Day 7 | 
| Changes of lactate dehydrogenase (LDH) |  | Day 1 | 
| Changes of lactate dehydrogenase (LDH) |  | Day 3 | 
| Changes of lactate dehydrogenase (LDH) |  | Day 7 | 
| Changes of creatine phosphokinase (CPK) |  | Day 1 | 
| Changes of creatine phosphokinase (CPK) |  | Day 3 | 
| Changes of creatine phosphokinase (CPK) |  | Day 7 | 
| Changes of Creatine kinase-MB (CK-MB) |  | Day 1 | 
| Changes of Creatine kinase-MB (CK-MB) |  | Day 3 | 
| Changes of Creatine kinase-MB (CK-MB) |  | Day 7 | 
| Changes of Specific IgG |  | Day 1 | 
| Changes of Specific IgG |  | Day 3 | 
| Changes of Specific IgG |  | Day 7 | 
| Radiological findings | Computed tomography Scan and Chest X-Ray | Within 2 hours after admission | 
| Radiological findings | Computed tomography Scan and Chest X-Ray | Day 14 | 
| Number of days ventilated |  | Through study completion, an average of 2 weeks | 
| Length of hospitalization |  | Through study completion, an average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus, COVID-19, SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2