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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04376788
Recruitment Status : Not yet recruiting
First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Mahmoud Moussa, 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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: exchange blood transfusion from normal donor Biological: plasma from convalescent patients with COVID-19 Drug: Methylene Blue 5 MG/ML Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19
Estimated Study Start Date : May 5, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Biological: exchange blood transfusion from normal donor
IV method

Experimental: 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.
Biological: plasma from convalescent patients with COVID-19
IV method

Drug: Methylene Blue 5 MG/ML
IV method

Experimental: 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.
Biological: exchange blood transfusion from normal donor
IV method

Biological: plasma from convalescent patients with COVID-19
IV method

Drug: Methylene Blue 5 MG/ML
IV method




Primary Outcome Measures :
  1. improvement of condition [ Time Frame: 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 :
  1. change in organs function with PFS and OS [ Time Frame: 0ne month ]
    change in the liver , kidney function and change in ferritin level with normal D Dimer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376788


Contacts
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Contact: Mohamed M Moussa +201001553744 drmohamed_metwali1@med.asu.edu.eg
Contact: Essam A Hassan, MD +201001839394 essam.abdelwahed@yahoo.com

Locations
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Egypt
Ain Shams University
Cairo, Egypt, 11556
Contact: Mohamed M Moussa, MD    +201001839394    drmohamed_metwali1@med.asu.edu.eg   
Contact: Essam A Hassan, MD    +201001939394    essam.abdelwahed@yahoo.com   
Principal Investigator: Mohamed M Moussa, MD         
Principal Investigator: Essam A Hassan, MD         
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Mohamed M Moussa Ain Shams University
Publications:
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Responsible Party: Mohamed Mahmoud Moussa, Professor Of Internal Medicine and Hematology -BMT, Ain Shams University
ClinicalTrials.gov Identifier: NCT04376788    
Other Study ID Numbers: FMASU P22/2020
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Mahmoud Moussa, Ain Shams University:
COVID-19
Exchange transfusion
Methylene blue
Additional relevant MeSH terms:
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Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action