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

Not Applicable

• Conditions: Coronavirus Infections
• Interventions: Biological: Convalescent Plasma

• Registration Number: NCT04327349
• Lead Sponsor: Mazandaran University of Medical Sciences

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-24
• Study Start: 2020-03-28
• Study First Submitted QC: 2020-03-30
• Last Update Submitted: 2020-03-30
• Study First Posted: 2020-03-31
• Last Update Posted: 2020-03-31
• Primary Completion: 2020-05-20
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COVID-19 Patients	Convalescent Plasma	-

Primary Outcome Measures

Name	Time	Method
Changes of C-reactive protein	Day 7	Measurement of CRP
Mortality changes in day 10	10 days after plasma transmission	Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
Changes of tumor necrosis factor-α	Day 7	Measurement of TNF-α
Changes of Interleukin 6	Day 7	Measurement of IL-6
Mortality changes in day 30	30 days after plasma transmission	Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
Changes of PaO2/FiO2 Ratio	Day 7	Partial pressure of arterial oxygen/Percentage of inspired oxygen

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Imam Khomeini Hospital, Mazandaran University of Medical Sciences; 🇮🇷 Sari, Mazandaran, Iran, Islamic Republic of