ChiCTR2000031501.

Study name	The efficacy of convalescent plasma in patients with critical novel coronavirus pneumonia (COVID‐19): a pragmatic, prospective cohort study
Methods	Trial design: prospective cohort study, controlled Sample size: 10 in each arm (20) Setting: inpatient Country: China Language: translated to English Number of centres: 1
Participants	Inclusion criteria Severe or critical patients with COVID‐19 pneumonia confirmed by novel coronavirus diagnosis and treatment plan (7th Edition) 18‐85 years old Obtaining informed consent Exclusion criteria Participating in clinical trials of other drugs Pregnant or lactating women ALT/AST > 5‐fold ULN, neutrophil < 0.5 x 10^9/L, platelet < 50 x 10^9/L Diagnosis of rheumatic immune‐related diseases was clear Long‐term oral anti‐rejection drugs or immunomodulatory drugs Hypersensitive reaction to mAb or any adjuvant Active TB patients with definite bacterial and fungal infection Patients with organ transplantation history within 3 months History of percutaneous coronary intervention in the past 60 days; COPD with end‐stage chronic diseases, including heart failure above NYHA grade III, chronic kidney disease with creatinine clearance < 40 mL/min or requiring family oxygen therapy
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP Details of CP: type of plasma: NR volume: NR number of doses: NR antibody‐titre: NR pathogen inactivated or not: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR For studies including a control group: comparator (type): routine treatment Concomitant therapy: NR Treatment cross‐overs: NR
Outcomes	Primary study outcome: hospital mortality 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): 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: invasive mechanical ventilation during infection; ECMO duration during infection: new receipt of high‐flow oxygen absorption, new receipt of non‐invasive mechanical ventilation, new receipt of continuous renal replacement therapy, new receipt of ECMO 30‐day and 90‐day mortality: hospital mortality, day 90 mortality Admission on the ICU: yes Length of stay on the ICU: ICU hospitalisation days Time to discharge from hospital: NR QoL: NR Additional study outcomes Time to COVID‐19 RT‐PCR‐negative in surviving patients Time of medical imaging improvement Lymphocyte count CRP IL‐6 New onset organ failure Incidence of secondary bacterial infection Incidence of secondary fungal infection Incidence of critical illness in severe patients Day 90 readmission for COVID‐19 pneumonia
Starting date	17 March 2020
Contact information	Weiqin LI liweiqindr@vip.163.com  Eastern Theater General Hospital   305 Zhongshandong road, Xuanwu district, Nanjing, Jiangsu, China
Notes	Recruitment status: recruiting Prospective completion date: 17 July 2020 Sponsor/funding: Eastern Theater General Hospital, 305 Zhongshan Road East, Xuanwu District, Nanjing, Jiangsu, China