ChiCTR2000030010.

Trial design: randomised, double‐blind, parallel‐controlled trial

Sample size: 50 in each arm (100)

Setting: inpatient

Country: China

Language: translated to English

Number of centres: 1

Inclusion criteria

• Aged 18‐70 years old, inpatients, male or female

• Patients with severe novel coronavirus infection: according to the "Pneumonitis Diagnosis and Treatment Guideline for the Novel Coronavirus Infection (Trial Version 5)", clinically diagnosed cases (suspected cases with pneumonia imaging features) or suspected cases. Severe patients must also meet any of the following: 1) respiratory distress, respiratory rate ≥ 30 times/min; 2) In the resting state, the oxygen saturation is ≤ 93%; 3) PaO₂/FiO₂ ≤ 300 mmHg (1 mm Hg = 0.133 kPa)

• Participants and/or legal guardians of the participants volunteered to participate in the study and voluntarily signed informed consent

Exclusion criteria

• The clinical classification of patients with severe novel coronavirus infection is to meet any of the following: 1) respiratory failure occurs and requires mechanical ventilation; 2) shock occurs; 3) 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)

• There is 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 3 months before screening

• Poor adherence or other conditions that the study author believes are not suitable for inclusion (such as poor physical condition)

CP therapy or hyperimmune immunoglobulin therapy: Anti‐SARS‐CoV‐2 virus inactivated plasma

Details of CP: 

• type of plasma: NR

• 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

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 outcomes

• All‐cause mortality at hospital discharge: 14‐ and 28‐day all‐cause mortality

• Time to death: NR

Secondary 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: 14‐ and 28‐day all‐cause mortality

• Admission on the ICU

• Length of stay on the ICU: ICU hospitalisation days

• Time to discharge from hospital

• QoL: NR

Additional study outcomes

• 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)

• Main clinical manifestations subsided or significantly improved (fever, dry cough, fatigue, etc.)

Recruitment status: not yet recruiting

Prospective completion date: 31 May 2020

Sponsor/funding: Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital), Sinopharm Wuhan Blood Products Co., Ltd., Sinopharm Wuhan Blood Products Co., Ltd