ChiCTR2000030929.

Study name	A randomized, double‐blind, parallel‐controlled trial to evaluate the efficacy and safety of anti‐SARS‐CoV‐2 virus inactivated plasma in the treatment of severe novel coronavirus pneumonia (COVID‐19)
Methods	Trial design: randomised, double‐blind, parallel‐controlled trial Sample size: 30 in each arm (60) Setting: inpatient Country: China Language: translated to English Number of centres: 1
Participants	Inclusion criteria Aged 18‐70 years old, inpatients, male or female Patients with severe COVID‐19: confirmed cases shall be in compliance with guideline of "Diagnosis and Treatment Plan for COVID‐19 (Version 7)" or updated versions. Confirmed cases can be defined if suspected cases have characteristic of following pathogeny or serology detect nucleic acid of novel coronavirus positive by real‐time fluorescent RT‐PCR have highly homologous to known novel coronavirus by sequencing detect sero‐specific lgM‐ and lgG‐positive; IgG‐specific against new coronavirus positive conversion or the titre of IgG is 4 times higher in convalescent period than in acute period Adult patients with severe COVID‐19 shall meet any of the following: respiratory distress, respiratory rate ≥ 30 times/minute in the resting state, oxygen saturation is ≤ 93% for lung radiology, the lesion has obtained > 50% obvious improvement within 24‐48 h PaO2)/FiO2 ≤ 300 mmHg (1 mmHg = 0.133 kPa) Patients and/or their legal guardians volunteered to participate in the study and voluntarily signed informed consent. Exclusion criteria Clinical classification of patients with severe novel coronavirus infection is to meet any of the following: respiratory failure occurs and requires mechanical ventilation; shock occurs; combined failure of other organs requires ICU monitoring and treatment Those who are allergic to blood products or plasma components and auxiliary materials (sodium citrate) Multiple organ failure, and the estimated survival time is < 3 days Those who tested positive for HIV antibodies before enrolment Women who are pregnant or breastfeeding or have a birth plan within the past year Participants in other clinical trials within 1 month before screening Poor adherence or other conditions that the study author believes are not suitable for inclusion (such as poor physical condition)
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP Details of CP: type of plasma: anti‐SARS CoV virus inactivated plasma volume: NR number of doses: NR antibody‐titre: NR pathogen inactivated or not: yes Treatment details, including time of plasma therapy (e.g. early stage of disease): NR For studies including a control group: comparator (type) ‐ ordinary plasma Concomitant therapy: NR Treatment cross‐overs: NR
Outcomes	Primary study outcome: improvement of clinical symptoms (clinical improvement is defined as a reduction of 2 points on the 6‐point scale of the patient's admission status or discharge from the hospital) Primary review outcomes reported: All‐cause mortality at hospital discharge: yes (at 14‐ and 28‐day) 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: Invasive mechanical ventilation during infection;  ECMO duration during infection: NR 30‐day and 90‐day mortality: 28‐day 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 Improving time of main clinical symptoms (wheezing, cough, sputum, etc)
Starting date	17 March 2020
Contact information	Lianghao Zhang  11443556@qq.com  Sinopharm Wuhan Blood Products Co., Ltd.  1 Golden Industrial Park Road, Zhengdian, Jiangxia District, Wuhan, Hubei, China
Notes	Recruitment status: not yet recruiting Prospective completion date: 16 June 2020 Sponsor/funding: Renmin Hospital of Wuhan University,  99 Zhang‐Zhi‐Dong Road, Wuchang District, Wuhan, Hubei, China