Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19
NCT ID: NCT04376788
Last Updated: 2020-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
15 participants
INTERVENTIONAL
2020-05-20
2020-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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Exchange transfusion
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
exchange blood transfusion from normal donor
IV method
Methylene blue with plasma
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.
plasma from convalescent patients with COVID-19
IV method
Methylene Blue 5 MG/ML
IV method
Exchange transfusion and methylene blue with plasma
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 blood transfusion from normal donor
IV method
plasma from convalescent patients with COVID-19
IV method
Methylene Blue 5 MG/ML
IV method
Interventions
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exchange blood transfusion from normal donor
IV method
plasma from convalescent patients with COVID-19
IV method
Methylene Blue 5 MG/ML
IV method
Eligibility Criteria
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Inclusion Criteria
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
2. Renal failure and heart failure.
3. Contraindication for plasma or blood transfusion.
18 Years
65 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Mohamed Mahmoud Moussa
Professor Of Internal Medicine and Hematology -BMT
Principal Investigators
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Mohamed M Moussa, MD
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University
Ayman I Tharwat, MD
Role: STUDY_DIRECTOR
Ain Shams University
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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FMASU P22/2020
Identifier Type: -
Identifier Source: org_study_id
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