ChiCTR2000030179.

Study name	Experimental study of novel coronavirus pneumonia rehabilitation plasma therapy severe novel coronavirus pneumonia (COVID‐19)
Methods	Trial design: randomised controlled trial Sample size: 50 in each arm (100) Setting: inpatient Country: China Language: translated to English Number of centres: 1
Participants	Inclusion criteria Confirmed participant (or legal guardian) agrees to participate in the study and signs the informed consent form Aged 18‐65 years Real‐time fluorescent RT‐PCR of respiratory specimens or blood specimens to detect patients positive for novel coronavirus Patients diagnosed as severe and critically ill and with rapid disease progression according to the "Diagnosis and Treatment Program for Pneumonia of New Coronavirus Infection (Trial Version 6)" Exclusion criteria  Any situation where the solution cannot be carried out safely Allergic constitution, allergic to plasma or drugs Being too old, with severe underlying diseases that affect survival, including uncontrolled clinically significant heart, lung, kidney, digestive, haematological, neuropsychiatric, immune, metabolic, or malignant tumours, severe malnutrition, etc Patients with severe respiratory failure, heart failure, and multiple organ failure Participants in other clinical trials
Interventions	CP therapy or hyperimmune immunoglobulin therapy: routine treatment + plasma treatment 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: no Treatment cross‐overs: no
Outcomes	Primary study outcomes: cure rate, mortality Primary review outcomes All‐cause mortality at hospital discharge: mortality Time to death: NR 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): 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: mortality Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: length of stay Additional study outcomes: cure rate
Starting date	24 February 2020
Contact information	Liu Wei  The First Affiliated Hospital of Nanchang University, 17 Yongwai Main Street, Nanchang, Jiangxi, China, 330006, cdyfyliuwei@163.com  Le Aiping  17 Yongwai Main Street, Nanchang, Jiangxi, China, 330006, leaiping@126.com
Notes	Recruitment status: recruiting Prospective completion date: 24 April 2020 Sponsor/funding: The First Affiliated Hospital of Nanchang University, raised independently