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

NCT04376788 | Unknown Phase 2

• 1 other identifier: FMASU P22/2020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to introduce way for treatment of patients with severe COVID-19 disease with respiratory complications.

Conditions

COVID-19

Keywords

COVID-19; Exchange transfusion; Methylene blue

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• change in organs function with PFS and OS

  0ne month

Study Arms (3)

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

Biological: exchange blood transfusion from normal donor

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.

Biological: plasma from convalescent patients with COVID-19; Drug: Methylene Blue 5 MG/ML

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.

Biological: exchange blood transfusion from normal donor; Biological: plasma from convalescent patients with COVID-19; Drug: Methylene Blue 5 MG/ML

Interventions

exchange blood transfusion from normal donor BIOLOGICAL

IV method

Exchange transfusion; Exchange transfusion and methylene blue with plasma

plasma from convalescent patients with COVID-19 BIOLOGICAL

IV method

Exchange transfusion and methylene blue with plasma; Methylene blue with plasma

Methylene Blue 5 MG/ML DRUG

IV method

Exchange transfusion and methylene blue with plasma; Methylene blue with plasma

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with pregnancy and lactation.
• Renal failure and heart failure.
• Contraindication for plasma or blood transfusion.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11556, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 32031568 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.

  PMID: 32003551 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mohamed M Moussa, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Ayman I Tharwat, MD

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Mohamed M Moussa, MD

CONTACT

+201001553744; drmohamed_metwali1@med.asu.edu.eg

Essam A Hassan, MD

CONTACT

+201001839394; essam.abdelwahed@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Of Internal Medicine and Hematology -BMT

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 6, 2020
• Study Start: May 20, 2020
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)