COVID-19 Clinical Trial
Official title:
Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19
The aim of this project is to introduce way for treatment of patients with severe COVID-19 disease with respiratory complications.
Study Tools AND/ OR procedure
The patients were subjected to the following:
Clinical parameters:
Complete history taking and thorough clinical examination
1. Laboratory parameters:
2. CBC with differential counts.
3. Reticulocytic count.
4. Blood film for shistocytes.
5. Serum ferritin and transferrin saturation.
6. D dimer.
7. Liver function tests, kidney function tests, electrolytes.
8. ESR.
9. CRP.
10. LDH.
11. Viral markers (HCV Ab, HBsV AG, HIV Ab).
12. ADAM'S 13 assays.
13. Serum soluble CD 25.
Other investigations:
1. Chest X ray.
2. Pelviabdominal US.
3. CT chest.
4. ECG.
5. Echocardiography
The patients will be divided into three groups, each group formed of 5 patients with severe
COVID-19 or on mechanical ventilator receiving standard of care All the groups matched
regarding age, sex and the severity of the disease.
Group I:
Will receive exchange transfusion by venesection of 500cc blood with good replacement of one
unit packed washed RBCs daily for 3 days according to daily clinical and investigational
follow up
Group II Will receive IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from
convalescent matching single patient by plasma extractor machine for 3 days according to
daily clinical and investigational follow up.
Group III Will receive exchange transfusion by venesection of 500cc blood with good
replacement of one unit packed washed RBCs and IV methylene blue 1 mg/kg IV over 30 minutes
with 200 CC plasma from convalescent matching single patient by plasma extractor machine for
3 days according to daily clinical and investigational follow up.
N.B.: Convalescent plasma and regular blood will be taken from ministry of health after
administrative approval All groups will receive
1. Low dose anticoagulant (LMWH 1 mg/kg/day).
2. Steroid (methyl prednisone 1 mg/ kg IV daily and according to patients' condition and
presence of complications like hemophagocytosis).
3. All allergic precautions if needed like antihistaminics , epinephrine and steroid.
Close monitoring for:
1. Allergic reactions.
2. ECG changes daily.
3. Volume overload.
4. Complications of other comorbidities like DM or HTN.
5. Liver function and kidney function and organ dysfunction daily.
Terms of discontinuation:
Deterioration of clinical condition or organ functions.
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