COVID-19
Conditions
Keywords
COVID-19, Exchange transfusion, Methylene blue
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.
Interventions
BIOLOGICALexchange blood transfusion from normal donor
IV method
BIOLOGICALplasma from convalescent patients with COVID-19
IV method
DRUGMethylene Blue 5 MG/ML
IV method
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactMohamed M Moussa, MD
Backup ContactEssam A Hassan, MD
Outcome results
None listed