. 2021 May 20;2021(5):CD013600. doi: 10.1002/14651858.CD013600.pub4

NCT04376788.

Study name	Exchange transfusion versus plasma from convalescent patients with methylene blue in patients with COVID‐19
Methods	Trial design: randomised, parallel‐assigned, open‐label, phase 2 Sample size: 15 (5 each group) Setting: inpatient Country: Egypt Language: translated to English Number of centres: 1
Participants	Inclusion criteria Adult patients are ≥ 18 years 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 < 93% resting Respiratory rate ≥ 30/min Exclusion criteria Patients with pregnancy and lactation Renal failure and heart failure Contraindication for plasma or blood transfusion
Interventions	Intervention(s): CP Details of CP (group I) Type of plasma: will receive exchange transfusion by venesection of 500 cc blood with good replacement of one unit packed washed red blood cells daily for 3 days according to daily clinical and investigational follow‐up Volume: 500 cc blood Number of doses: Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR Details of CP (group II) Type of plasma: will receive IV methylene blue 1 mg/kg IV over 30 min with 200 cc plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow‐up. Volume: IV methylene blue 1 mg/kg IV over 30 min with 200 cc plasma Number of doses: Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR Details of CP (group III) Type of plasma: will receive exchange transfusion by venesection of 500 cc blood with good replacement of 1 unit packed washed red blood cells and IV methylene blue 1 mg/kg IV over 30 min with 200 cc plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow‐up Volume: venesection of 500 cc blood Number of doses: 1 Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR Concomitant therapy: NR Treatment cross‐overs: no
Outcomes	Primary study outcome Improvement of condition (time frame: 3‐5 days) (improvement of general condition of the participants as the ventilator parameters and serum level of ferritin, D dimer, complete blood count, oxygen level in blood and patient O₂ saturation) Primary review outcomes reported All‐cause mortality at hospital discharge: NR Time to death: NR Secondary review outcomes reported Number of participants with grade 3 and grade 4 AEs, including potential relationship between intervention and adverse reaction (e.g. TRALI, transfusion‐transmitted infection, TACO, TAD, acute transfusion reactions): NR Number of participants with SAEs: NR Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: NR 30‐day and 90‐day mortality: NR Admission to the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Additional study outcomes improvement of condition (time frame: 3‐5 days) (improvement of general condition of the participants as the ventilator parameters and serum level of ferritin, D‐dimer, complete blood count, oxygen level in blood and patient O₂ saturation) change in organs function with progression‐free survival and overall survival (time frame: 1 month) change in the liver, kidney function and change in ferritin level with normal D Dimer
Starting date	6 May 2020
Contact information	Contact: Mohamed M Moussa, MD: +201001553744; drmohamed_metwali1@med.asu.edu.eg Contact: Essam A Hassan, MD: +201001839394; essam.abdelwahed@yahoo.com
Notes	Recruitment status: recruiting Prospective completion date: 1 July 2020 Sponsor/funding: Ain Shams University Principal Investigator: Mohamed M Moussa, Ain Shams University