NCT04403477.

Study name	Convalescent plasma transfusion therapy in severe COVID‐19 patients‐ a tolerability, efficacy and dose‐response phase II RCT
Methods	Trial design: RCT Sample size: 60 in 3 arms of 20 each Setting: inpatient Country: Bangladesh Language: English Number of centres: 3
Participants	Inclusion criteria Respiratory rate > 30 breaths/min; PLUS Severe respiratory distress; or SpO2 ≤ 88% on room air or PaO2/FiO2≤ 300 mm of Hg, PLUS Radiological evidence of bilateral lung infiltrate, AND OR Systolic BP < 90 mm of Hg or diastolic BP <60 mm of Hg. AND OR Criteria 1 to 4 AND or patient in ventilator support Exclusion criteria Patients < 18 years Pregnant women and breast‐feeding mothers Previous history of allergic reaction to plasma Those who will not give consent Donor eligibility criteria  Between day 22 and day 35 of recovery 2 consecutive negative RT‐PCR samples Antibody titre > 1:320 Donor exclusion criteria NR
Interventions	Intervention(s): CP therapy Details of CP: Type of plasma: NR Volume: 200 mL (Arm‐B); 400 mL (Arm‐C) Number of doses: 1 Antibody‐titre: determined by endpoint dilution Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): hospitalised patients with RT‐PCR‐confirmed diagnosis Comparator: standard care (Arm‐A) Concomitant therapy: enoxaparin, antibiotic, fluid, immune modulator (steroid) and or antiviral (favipiravir or ramdesivir or lopinavir + ritonavir) Treatment cross‐overs: no
Outcomes	Primary study outcome:  Proportion of in‐hospital mortality Time to death Primary review outcomes reported All‐cause mortality at hospital discharge: yes Time to death: yes 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: yes 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: yes, to 14 days 30‐day and 90‐day mortality: yes to 7 days Admission on the ICU: yes to 14 days Length of stay on the ICU: yes to 14 days Time to discharge from hospital: yes to 14 days QoL: NR Additional outcomes Fever (time frame: 7 days); temperature in degree Fahrenheit at Day 0, 1, 3, 7 Respiratory distress (time frame: 7 days); respiratory rate per minute at Day 0, 1, 3, 7 Saturation of oxygen (time frame: 7 days); saturation of oxygen in % at Day 0, 1, 3, 7 Blood pressure (time frame: 7 days); blood pressure in mm of Hg at Day 0, 1, 3, 7 CRP (time frame: Day 0, 3 and 7); CRP level in mg/L Ferritin (time frame: Day 0, 3 and 7); serum ferritin level in ng/mL Serum glutamic‐pyruvic transaminase (SGPT) (time frame: Day 0, 3 and 7); serum SGPT level in I/U Serum glutamic‐oxaloacetic transaminase (SGOT) (time frame: Day 0, 3 and 7); serum SGOT level in I/U
Starting date	20 May 2020
Contact information	Mohammad S Rahman, M Phil, FCPS +88 01971840757 srkhasru@gmail.com Fazle R Chowdhury, FCPS; PhD +88 01916578699 mastershakil@hotmail.com
Notes	Recruitment status: recruiting Prospective completion date: 20 July 2020 Sponsor/funding: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh; Dhaka Medical College