NCT04292340.

Study name	The efficacy and safety of anti‐SARS‐CoV‐2 inactivated convalescent plasma in the treatment of novel coronavirus pneumonia patient (COVID‐19): an observational study
Methods	Trial design: prospective single‐arm intervention study Sample size: 15 Setting: inpatient Country: China Language: English Number of centres: 1
Participants	Inclusion criteria Participants were diagnosed as COVID‐19 Participants received anti‐SARS‐CoV‐2 inactivated CP Written informed consent Exclusion criteria Participants lacked detailed medical history
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): not applicable Concomitant therapy: NR Treatment cross‐overs: NR
Outcomes	Primary study outcome: Virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1, day 3 and day 7, numbers of participants with different clinical outcomes Primary review outcomes All‐cause mortality at hospital discharge: yes 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: yes 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: NR Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Additional outcomes Virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1, day 3 and day 7 (time frame: 1 day/3 days/7 days after receiving plasma transmission) Numbers of participants with different clinical outcomes (time frame: from receiving plasma transmission to 4 weeks) clinical outcomes include death, critical illness, recovery
Starting date	1 February 2020
Contact information	Hongzhou Lu, Ph.D+86‐021‐37990333 ext 3222 luhongzhou@fudan.edu.cn Shanghai Public Health Clinical Center Shanghai, Shanghai, China, 201508
Notes	Recruitment status: recruiting Prospective completion date: 31 July 2020 Sponsor/funding: Shanghai Public Health Clinical Center