Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19

Ain Shams University

Status and phase: Unknown; Phase 2

Conditions: COVID-19

Treatments: Biological: exchange blood transfusion from normal donor; Biological: plasma from convalescent patients with COVID-19; Drug: Methylene Blue 5 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT04376788

FMASU P22/2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Exchange transfusion

Experimental group

Description:

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

Treatment:

Biological: exchange blood transfusion from normal donor

Methylene blue with plasma

Experimental group

Description:

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.

Treatment:

Biological: plasma from convalescent patients with COVID-19

Drug: Methylene Blue 5 MG/ML

Exchange transfusion and methylene blue with plasma

Experimental group

Description:

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.

Treatment:

Biological: plasma from convalescent patients with COVID-19

Drug: Methylene Blue 5 MG/ML

Biological: exchange blood transfusion from normal donor