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. 2020 Jul 10;2020(7):CD013600. doi: 10.1002/14651858.CD013600.pub2

Bao 2020b.

Study characteristics
Methods
  • Trial design: case report 

  • Type of publication: epub, ahead of print 

  • Setting: hospital

  • Recruitment dates: 16 February‐19 March 2020

  • Country: China

  • Language: English

  • Number of centres: 1

  • Trial registration number: NR

  • Date of registration: NR

Participants
  • Age: 38

  • Gender: male

  • Ethnicity: NR

  • Number of participants (recruited/allocated/evaluated): 1

  • Severity of disease: severe

  • Co‐morbidities: nil 

  • Inclusion criteria: NR

  • Exclusion criteria: NR

  • Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): NR

Interventions
  • CP therapy or hyperimmune immunoglobulin therapy: CP therapy

  • Details of CP:

    • Type of plasma: ABO‐compatible 

    • Volume: 150ml to 200 mL each dose

    • Number of doses: 2

    • Antibody test and antibody‐titre: NR

    • Pathogen inactivated or not: NR

    • RT‐PCR tested: NR

  • Details of donors:

    • Gender: NR

    • HLA and HNA antibody‐negative: NR

    • Severity of disease: NR

    • Timing from recovery from disease: NR

    • RT‐PCR tested: NR

  • Treatment details, including time of plasma therapy (e.g. early stage of disease): administered between 9 and 24 days after admission

  • For studies including a control group: comparator (type): not applicable

  • Concomitant therapy: antibiotics, haemostatic drugs were administered, low‐temperature noradrenaline dilution solution and low‐temperature thrombin solution, antifungals, antivirals, tracheostomy, ventilation, craniotomy, mannitol

  • Duration of follow‐up: up to 32 days

  • Treatment cross‐overs: not applicable

  • Compliance with assigned treatment: not applicable 

Outcomes
  • Primary study outcome(s): NR

  • Primary review outcomes

    • All‐cause mortality at hospital discharge: reported

    • Time to death: not applicable

  • 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: reported

    • 30‐day and 90‐day mortality: not applicable

    • Admission to the ICU: reported

    • Length of stay on the ICU: NR

    • Time to discharge from hospital: NR 

    • QoL: NR

  • Additional study outcomes: NR

Notes
  • Sponsor/funding: no funding received

  • COIs: all study authors declare no competing interests

  • Other: nil