Clinical trial NCT04327349: Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
Official title: Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronavirus Infections
Keywords: Coronavirus
COVID-19
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Mortality changes in day 10
timeFrame: 10 days after plasma transmission
measure: Mortality changes in day 30
timeFrame: 30 days after plasma transmission
measure: Changes of C-reactive protein
timeFrame: Day 1
measure: Changes of C-reactive protein
timeFrame: Day 3
measure: Changes of C-reactive protein
timeFrame: Day 7
measure: Changes of Interleukin 6
timeFrame: Day 1
measure: Changes of Interleukin 6
timeFrame: Day 3
measure: Changes of Interleukin 6
timeFrame: Day 7
measure: Changes of tumor necrosis factor-α
timeFrame: Day 1
measure: Changes of tumor necrosis factor-α
timeFrame: Day 3
measure: Changes of tumor necrosis factor-α
timeFrame: Day 7
measure: Changes of PaO2/FiO2 Ratio
timeFrame: Day 1
measure: Changes of PaO2/FiO2 Ratio
timeFrame: Day 3
measure: Changes of PaO2/FiO2 Ratio
timeFrame: Day 7
Secondary outcomes:
measure: Changes of CD3
timeFrame: Day 1
measure: Changes of CD3
timeFrame: Day 3
measure: Changes of CD3
timeFrame: Day 7
measure: Changes of CD4
timeFrame: Day 1
measure: Changes of CD4
timeFrame: Day 3
measure: Changes of CD4
timeFrame: Day 7
measure: Changes of CD8
timeFrame: Day 1
measure: Changes of CD8
timeFrame: Day 3
measure: Changes of CD8
timeFrame: Day 7
measure: Changes of CD4/CD8 ratio
timeFrame: Day 1
measure: Changes of CD4/CD8 ratio
timeFrame: Day 3
measure: Changes of CD4/CD8 ratio
timeFrame: Day 7
measure: Changes of lymphocyte count
timeFrame: Day 1
measure: Changes of lymphocyte count
timeFrame: Day 3
measure: Changes of lymphocyte count
timeFrame: Day 7
measure: Changes of leukocyte count
timeFrame: Day 1
measure: Changes of leukocyte count
timeFrame: Day 3
measure: Changes of leukocyte count
timeFrame: Day 7
measure: Changes of alanine transaminase (ALT)
timeFrame: Day 1
measure: Changes of alanine transaminase (ALT)
timeFrame: Day 3
measure: Changes of alanine transaminase (ALT)
timeFrame: Day 7
measure: Changes of aspartate transaminase (AST)
timeFrame: Day 1
measure: Changes of aspartate transaminase (AST)
timeFrame: Day 3
measure: Changes of aspartate transaminase (AST)
timeFrame: Day 7
measure: Changes of alkaline phosphatase (ALP)
timeFrame: Day 1
measure: Changes of alkaline phosphatase (ALP)
timeFrame: Day 3
measure: Changes of alkaline phosphatase (ALP)
timeFrame: Day 7
measure: Changes of lactate dehydrogenase (LDH)
timeFrame: Day 1
measure: Changes of lactate dehydrogenase (LDH)
timeFrame: Day 3
measure: Changes of lactate dehydrogenase (LDH)
timeFrame: Day 7
measure: Changes of creatine phosphokinase (CPK)
timeFrame: Day 1
measure: Changes of creatine phosphokinase (CPK)
timeFrame: Day 3
measure: Changes of creatine phosphokinase (CPK)
timeFrame: Day 7
measure: Changes of Creatine kinase-MB (CK-MB)
timeFrame: Day 1
measure: Changes of Creatine kinase-MB (CK-MB)
timeFrame: Day 3
measure: Changes of Creatine kinase-MB (CK-MB)
timeFrame: Day 7
measure: Changes of Specific IgG
timeFrame: Day 1
measure: Changes of Specific IgG
timeFrame: Day 3
measure: Changes of Specific IgG
timeFrame: Day 7
measure: Radiological findings
timeFrame: Within 2 hours after admission
measure: Radiological findings
timeFrame: Day 14
measure: Number of days ventilated
timeFrame: Through study completion, an average of 2 weeks
measure: Length of hospitalization
timeFrame: Through study completion, an average of 2 weeks
Other outcomes:
Locations:
city: Sari
country: Iran, Islamic Republic of
facility: Imam Khomeini Hospital, Mazandaran University of Medical Sciences
state: Mazandaran
Study officials:
affiliation: Vice-Chancellor for Research, Mazandaran University of Medical Sciences
name: Majid Saeedi, Ph.D.
role: STUDY_CHAIR
References: