ChiCTR2000030627.

Study name	Study for using the healed novel coronavirus pneumonia (COVID‐19) patients plasma in the treatment of severe critical cases
Methods	Trial design: RCT Sample size: 15 in each arm (30) Setting: inpatient Country: China Language: translated to English Number of centres: 1
Participants	Inclusion criteria  Patients who were diagnosed as COVID‐19 by nucleic acid test and were in accordance with the clinical classification of severe or critically illness. (Refer to the clinical classification criteria in the pneumonia diagnosis and treatment program of novel coronavirus infection, General Office of the National Health Commission (trial version 4)) Exclusion criteria Patients with hypersensitivity to plasma products; patients with severe transfusion reactions in the past; patients with acute pulmonary oedema, congestive heart failure, PE, malignant hypertension, polycythaemia vera, extreme renal failure and other diseases
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP  Details of CP: NR 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: no Treatment cross‐overs: no
Outcomes	Primary study outcomes: temperature, virus nucleic acid detection Primary review outcomes All‐cause mortality at hospital discharge: mortality rate Time to death Secondary review outcomes 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): incidence of AEs in blood transfusion Number of participants with SAEs 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: yes Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: length of admission QoL: NR Additional study outcomes Laboratory examination
Starting date	1 February 2020
Contact information	Guojun Zhang  The First Affiliated Hospital of Zhengzhou University, 1 Jianshe Road East, Zhengzhou, He'nan, China, zlgj‐001@126.com  Guojun Zhang  1 Jianshe Road East, Zhengzhou, He'nan, China, zlgj‐001@126.com
Notes	Recruitment status: recruiting Prospective completion date: 30 May 2020 Sponsor/funding: The First Affiliated Hospital of Zhengzhou University, Science and Technology Department of He'nan Province