Coronavirus Infections
Conditions
Keywords
Coronavirus, COVID-19, SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2
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
Interventions
BIOLOGICALConvalescent Plasma
Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU
Sponsors
Mazandaran University of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 C-reactive protein | Day 1 | Measurement of CRP |
| Changes of Interleukin 6 | Day 1 | Measurement of IL-6 |
| Changes of tumor necrosis factor-α | Day 1 | Measurement of TNF-α |
| Changes of PaO2/FiO2 Ratio | Day 1 | Partial pressure of arterial oxygen/Percentage of inspired oxygen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of CD3 | Day 1 | — |
| Changes of CD4 | Day 1 | — |
| Changes of CD8 | Day 1 | — |
| Changes of CD4/CD8 ratio | Day 1 | — |
| Changes of lymphocyte count | Day 1 | — |
| Changes of creatine phosphokinase (CPK) | Day 1 | — |
| Changes of alanine transaminase (ALT) | Day 1 | — |
| Changes of aspartate transaminase (AST) | Day 1 | — |
| Changes of alkaline phosphatase (ALP) | Day 1 | — |
| Changes of lactate dehydrogenase (LDH) | Day 1 | — |
| Changes of leukocyte count | Day 1 | — |
| Changes of Creatine kinase-MB (CK-MB) | Day 1 | — |
| Changes of Specific IgG | Day 1 | — |
| Radiological findings | Within 2 hours after admission | Computed tomography Scan and Chest X-Ray |
| Number of days ventilated | Through study completion, an average of 2 weeks | — |
| Length of hospitalization | Through study completion, an average of 2 weeks | — |
Countries
Iran
Outcome results
None listed