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

Mazandaran University of Medical Sciences30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronavirus Infections

Interventions

Convalescent Plasma

Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 transmission 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

Locations (1)

Imam Khomeini Hospital, Mazandaran University of Medical Sciences

Sari, Mazandaran, Iran

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 30 days after plasma transmission

Changes of C-reactive protein

Measurement of CRP

Time frame: Day 1

Changes of C-reactive protein

Measurement of CRP

Time frame: Day 3

Changes of C-reactive protein

Measurement of CRP

Time frame: Day 7

Changes of Interleukin 6

Measurement of IL-6

Time frame: Day 1

Changes of Interleukin 6

Measurement of IL-6

Time frame: Day 3

Changes of Interleukin 6

Measurement of IL-6

Time frame: Day 7

Changes of tumor necrosis factor-α

Measurement of TNF-α

Time frame: Day 1

Changes of tumor necrosis factor-α

Measurement of TNF-α

Time frame: Day 3

Changes of tumor necrosis factor-α

Measurement of TNF-α

Time frame: Day 7

Changes of PaO2/FiO2 Ratio

Partial pressure of arterial oxygen/Percentage of inspired oxygen

Time frame: Day 1

Changes of PaO2/FiO2 Ratio

Partial pressure of arterial oxygen/Percentage of inspired oxygen

Time frame: Day 3

Changes of PaO2/FiO2 Ratio

Partial pressure of arterial oxygen/Percentage of inspired oxygen

Time frame: Day 7

Secondary Outcomes

Changes of CD3

Time frame: Day 1

Changes of CD3

Time frame: Day 3

Changes of CD3

Time frame: Day 7

Changes of CD4

Time frame: Day 1

Changes of CD4

Time frame: Day 3

Changes of CD4

Time frame: Day 7

Changes of CD8

Time frame: Day 1

Changes of CD8

Time frame: Day 3

Changes of CD8

Time frame: Day 7

Changes of CD4/CD8 ratio

Time frame: Day 1

Changes of CD4/CD8 ratio

Time frame: Day 3

Changes of CD4/CD8 ratio

Time frame: Day 7

Changes of lymphocyte count

Time frame: Day 1

Changes of lymphocyte count

Time frame: Day 3

Changes of lymphocyte count

Time frame: Day 7

Changes of leukocyte count

Data from ClinicalTrials.gov

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Changes of leukocyte count

Time frame: Day 3

Changes of leukocyte count

Time frame: Day 7

Changes of alanine transaminase (ALT)

Time frame: Day 1

Changes of alanine transaminase (ALT)

Time frame: Day 3

Changes of alanine transaminase (ALT)

Time frame: Day 7

Changes of aspartate transaminase (AST)

Time frame: Day 1

Changes of aspartate transaminase (AST)

Time frame: Day 3

Changes of aspartate transaminase (AST)

Time frame: Day 7

Changes of alkaline phosphatase (ALP)

Time frame: Day 1

Changes of alkaline phosphatase (ALP)

Time frame: Day 3

Changes of alkaline phosphatase (ALP)

Time frame: Day 7

Changes of lactate dehydrogenase (LDH)

Time frame: Day 1

Changes of lactate dehydrogenase (LDH)

Time frame: Day 3

Changes of lactate dehydrogenase (LDH)

Time frame: Day 7

Changes of creatine phosphokinase (CPK)

Time frame: Day 1

Changes of creatine phosphokinase (CPK)

Time frame: Day 3

Changes of creatine phosphokinase (CPK)

Time frame: Day 7

Changes of Creatine kinase-MB (CK-MB)

Time frame: Day 1

Changes of Creatine kinase-MB (CK-MB)

Time frame: Day 3

Changes of Creatine kinase-MB (CK-MB)

Time frame: Day 7

Changes of Specific IgG

Time frame: Day 1

Changes of Specific IgG

Time frame: Day 3

Changes of Specific IgG

Time frame: Day 7

Radiological findings

Computed tomography Scan and Chest X-Ray

Time frame: Within 2 hours after admission

Radiological findings

Computed tomography Scan and Chest X-Ray

Time frame: Day 14

Number of days ventilated

Time frame: Through study completion, an average of 2 weeks

Length of hospitalization

Time frame: Through study completion, an average of 2 weeks