Official Title
Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19
Brief Summary

The aim of this project is to introduce way for treatment of patients with severe COVID-19 disease with respiratory complications.

Detailed Description

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.

Unknown status
COVID-19

Biological: exchange blood transfusion from normal donor

IV method

Biological: plasma from convalescent patients with COVID-19

IV method

Drug: Methylene Blue 5 MG/ML

IV method

Eligibility Criteria

Inclusion Criteria:

1. Adult patients are 18 years old or above.

2. Inpatients diagnosed as severe COVID - 19 disease according to WHO criteria.

3. CT chest with extensive lung disease (ground-glass and consolidative pulmonary
opacities).

4. O2 saturation less than 93% resting.

5. Respiratory rate equal or more than 30 per minute.

Exclusion Criteria:

1. Patients with pregnancy and lactation.

2. Renal failure and heart failure.

3. Contraindication for plasma or blood transfusion.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
Egypt
Locations

Ain Shams University
Cairo, Egypt

Investigator: Mohamed M Moussa, MD
Contact: +201001839394
drmohamed_metwali1@med.asu.edu.eg

Investigator:

Contacts

Mohamed M Moussa, MD
+201001553744
drmohamed_metwali1@med.asu.edu.eg

Essam A Hassan, MD
+201001839394
essam.abdelwahed@yahoo.com

Ain Shams University
NCT Number
Keywords
Covid-19
Exchange transfusion
Methylene blue
MeSH Terms
COVID-19
Methylene Blue