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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
exchange blood transfusion from normal donor
plasma from convalescent patients with COVID-19
Methylene Blue 5 MG/ML
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Exchange transfusion, Methylene blue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Exchange transfusion

Methylene blue with plasma

Exchange transfusion and methylene blue with plasma

Arm 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

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

change in organs function with PFS and OS
change in the liver , kidney function and change in ferritin level with normal D Dimer

Full Information

First Posted
May 1, 2020
Last Updated
July 7, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04376788
Brief Title
Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19
Acronym
COVID-19
Official Title
Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 Laboratory parameters: CBC with differential counts. Reticulocytic count. Blood film for shistocytes. Serum ferritin and transferrin saturation. D dimer. Liver function tests, kidney function tests, electrolytes. ESR. CRP. LDH. Viral markers (HCV Ab, HBsV AG, HIV Ab). ADAM'S 13 assays. Serum soluble CD 25. Other investigations: Chest X ray. Pelviabdominal US. CT chest. ECG. 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 Low dose anticoagulant (LMWH 1 mg/kg/day). Steroid (methyl prednisone 1 mg/ kg IV daily and according to patients' condition and presence of complications like hemophagocytosis). All allergic precautions if needed like antihistaminics , epinephrine and steroid. Close monitoring for: Allergic reactions. ECG changes daily. Volume overload. Complications of other comorbidities like DM or HTN. Liver function and kidney function and organ dysfunction daily. Terms of discontinuation: Deterioration of clinical condition or organ functions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Exchange transfusion, Methylene blue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exchange transfusion
Arm Type
Experimental
Arm 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
Arm Title
Methylene blue with plasma
Arm Type
Experimental
Arm 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.
Arm Title
Exchange transfusion and methylene blue with plasma
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
exchange blood transfusion from normal donor
Intervention Description
IV method
Intervention Type
Biological
Intervention Name(s)
plasma from convalescent patients with COVID-19
Intervention Description
IV method
Intervention Type
Drug
Intervention Name(s)
Methylene Blue 5 MG/ML
Intervention Description
IV method
Primary Outcome Measure Information:
Title
improvement of condition
Description
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
Time Frame
three to five days days
Secondary Outcome Measure Information:
Title
change in organs function with PFS and OS
Description
change in the liver , kidney function and change in ferritin level with normal D Dimer
Time Frame
0ne month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients are 18 years old or above. Inpatients diagnosed as severe COVID - 19 disease according to WHO criteria. CT chest with extensive lung disease (ground-glass and consolidative pulmonary opacities). O2 saturation less than 93% resting. Respiratory rate equal or more than 30 per minute. Exclusion Criteria: Patients with pregnancy and lactation. Renal failure and heart failure. Contraindication for plasma or blood transfusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M Moussa, MD
Phone
+201001553744
Email
drmohamed_metwali1@med.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Essam A Hassan, MD
Phone
+201001839394
Email
essam.abdelwahed@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M Moussa, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayman I Tharwat, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11556
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M Moussa, MD
Phone
+201001839394
Email
drmohamed_metwali1@med.asu.edu.eg
First Name & Middle Initial & Last Name & Degree
Essam A Hassan, MD
Phone
+201001939394
Email
essam.abdelwahed@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohamed M Moussa, MD
First Name & Middle Initial & Last Name & Degree
Essam A Hassan, MD
First Name & Middle Initial & Last Name & Degree
Ayman I Tharwat, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32031568
Citation
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.
Results Reference
background
PubMed Identifier
32003551
Citation
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.
Results Reference
background

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

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