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

Coronavirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04327349
• Other study ID #: IR.MAZUMS.REC.1399.7330
• Secondary ID: IRCT201811040415
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 28, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: March 2020
• Source: Mazandaran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: September 30, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Intervention

Biological:
• Convalescent Plasma
Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Khomeini Hospital, Mazandaran University of Medical Sciences	Sari	Mazandaran

Sponsors (1)

Lead Sponsor	Collaborator
Mazandaran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Changes of C-reactive protein	Measurement of CRP	Day 1
Primary	Changes of C-reactive protein	Measurement of CRP	Day 3
Primary	Changes of C-reactive protein	Measurement of CRP	Day 7
Primary	Changes of Interleukin 6	Measurement of IL-6	Day 1
Primary	Changes of Interleukin 6	Measurement of IL-6	Day 3
Primary	Changes of Interleukin 6	Measurement of IL-6	Day 7
Primary	Changes of tumor necrosis factor-a	Measurement of TNF-a	Day 1
Primary	Changes of tumor necrosis factor-a	Measurement of TNF-a	Day 3
Primary	Changes of tumor necrosis factor-a	Measurement of TNF-a	Day 7
Primary	Changes of PaO2/FiO2 Ratio	Partial pressure of arterial oxygen/Percentage of inspired oxygen	Day 1
Primary	Changes of PaO2/FiO2 Ratio	Partial pressure of arterial oxygen/Percentage of inspired oxygen	Day 3
Primary	Changes of PaO2/FiO2 Ratio	Partial pressure of arterial oxygen/Percentage of inspired oxygen	Day 7
Secondary	Changes of CD3		Day 1
Secondary	Changes of CD3		Day 3
Secondary	Changes of CD3		Day 7
Secondary	Changes of CD4		Day 1
Secondary	Changes of CD4		Day 3
Secondary	Changes of CD4		Day 7
Secondary	Changes of CD8		Day 1
Secondary	Changes of CD8		Day 3
Secondary	Changes of CD8		Day 7
Secondary	Changes of CD4/CD8 ratio		Day 1
Secondary	Changes of CD4/CD8 ratio		Day 3
Secondary	Changes of CD4/CD8 ratio		Day 7
Secondary	Changes of lymphocyte count		Day 1
Secondary	Changes of lymphocyte count		Day 3
Secondary	Changes of lymphocyte count		Day 7
Secondary	Changes of leukocyte count		Day 1
Secondary	Changes of leukocyte count		Day 3
Secondary	Changes of leukocyte count		Day 7
Secondary	Changes of alanine transaminase (ALT)		Day 1
Secondary	Changes of alanine transaminase (ALT)		Day 3
Secondary	Changes of alanine transaminase (ALT)		Day 7
Secondary	Changes of aspartate transaminase (AST)		Day 1
Secondary	Changes of aspartate transaminase (AST)		Day 3
Secondary	Changes of aspartate transaminase (AST)		Day 7
Secondary	Changes of alkaline phosphatase (ALP)		Day 1
Secondary	Changes of alkaline phosphatase (ALP)		Day 3
Secondary	Changes of alkaline phosphatase (ALP)		Day 7
Secondary	Changes of lactate dehydrogenase (LDH)		Day 1
Secondary	Changes of lactate dehydrogenase (LDH)		Day 3
Secondary	Changes of lactate dehydrogenase (LDH)		Day 7
Secondary	Changes of creatine phosphokinase (CPK)		Day 1
Secondary	Changes of creatine phosphokinase (CPK)		Day 3
Secondary	Changes of creatine phosphokinase (CPK)		Day 7
Secondary	Changes of Creatine kinase-MB (CK-MB)		Day 1
Secondary	Changes of Creatine kinase-MB (CK-MB)		Day 3
Secondary	Changes of Creatine kinase-MB (CK-MB)		Day 7
Secondary	Changes of Specific IgG		Day 1
Secondary	Changes of Specific IgG		Day 3
Secondary	Changes of Specific IgG		Day 7
Secondary	Radiological findings	Computed tomography Scan and Chest X-Ray	Within 2 hours after admission
Secondary	Radiological findings	Computed tomography Scan and Chest X-Ray	Day 14
Secondary	Number of days ventilated		Through study completion, an average of 2 weeks
Secondary	Length of hospitalization		Through study completion, an average of 2 weeks