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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
Other investigations:
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
Close monitoring for:
Terms of discontinuation:
Deterioration of clinical condition or organ functions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exchange transfusion | Experimental | 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 | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exchange blood transfusion from normal donor | Biological | IV method |
|
| Measure | Description | Time Frame |
|---|---|---|
| improvement of condition | 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 | three to five days days |
| Measure | Description | Time Frame |
|---|---|---|
| change in organs function with PFS and OS | change in the liver , kidney function and change in ferritin level with normal D Dimer | 0ne month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed M Moussa, MD | Contact | +201001553744 | drmohamed_metwali1@med.asu.edu.eg | |
| Essam A Hassan, MD | Contact | +201001839394 | essam.abdelwahed@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed M Moussa, MD | Ain Shams University | Principal Investigator |
| Ayman I Tharwat, MD | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | 11556 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32031568 | Background | Chang D, Lin M, Wei L, Xie L, Zhu G, Dela Cruz CS, Sharma L. Epidemiologic and Clinical Characteristics of Novel Coronavirus Infections Involving 13 Patients Outside Wuhan, China. JAMA. 2020 Mar 17;323(11):1092-1093. doi: 10.1001/jama.2020.1623. | |
| 32003551 | Background | Rothe C, Schunk M, Sothmann P, Bretzel G, Froeschl G, Wallrauch C, Zimmer T, Thiel V, Janke C, Guggemos W, Seilmaier M, Drosten C, Vollmar P, Zwirglmaier K, Zange S, Wolfel R, Hoelscher M. Transmission of 2019-nCoV Infection from an Asymptomatic Contact in Germany. N Engl J Med. 2020 Mar 5;382(10):970-971. doi: 10.1056/NEJMc2001468. Epub 2020 Jan 30. No abstract available. |
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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.
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| plasma from convalescent patients with COVID-19 | Biological | IV method |
|
| Methylene Blue 5 MG/ML | Drug | IV method |
|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008751 | Methylene Blue |
| ID | Term |
|---|---|
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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