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

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 Overview

• Status: Unknown
• Conditions: Coronavirus Infections
• Intervention / Treatment: Biological: Convalescent Plasma

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Mazandaran
    • Sari, Mazandaran, Iran, Islamic Republic of, 4816633131
      • Imam Khomeini Hospital, Mazandaran University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: COVID-19 Patients	Biological: Convalescent Plasma; Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mazandaran University of Medical Sciences
• Investigators: Study Chair: Majid Saeedi, Ph.D., Vice-Chancellor for Research, Mazandaran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): March 28, 2020
• Primary Completion (Anticipated): May 20, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Coronavirus; COVID-19; Severe acute respiratory syndrome coronavirus 2
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: IR.MAZUMS.REC.1399.7330; IRCT20181104041551N1 (Registry Identifier: Iranian Registry of Clinical Trials (IRCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No