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

Phase 2

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

• Registration Number: NCT04376788
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study First Submitted: 2020-05-01
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-06
• Study Start: 2020-05-20
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

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Exclusion Criteria

1. Patients with pregnancy and lactation.
2. Renal failure and heart failure.
3. Contraindication for plasma or blood transfusion.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exchange transfusion and methylene blue with plasma	Methylene Blue 5 MG/ML	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.
Methylene blue with plasma	plasma from convalescent patients with COVID-19	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.
Exchange transfusion and methylene blue with plasma	exchange blood transfusion from normal donor	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.
Exchange transfusion	exchange blood transfusion from normal donor	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
Methylene blue with plasma	Methylene Blue 5 MG/ML	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.
Exchange transfusion and methylene blue with plasma	plasma from convalescent patients with COVID-19	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.

Primary Outcome Measures

Name	Time	Method
improvement of condition	three to five days days	improvement of general condition of the patients as the ventilator parameters and serum level of ferritin , D dimer, CBC, oxygen level in blood and patient o2 saturation

Secondary Outcome Measures

Name	Time	Method
change in organs function with PFS and OS	0ne month	change in the liver , kidney function and change in ferritin level with normal D Dimer

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt