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

Yang 2020.

Study characteristics
Methods
  • Trial design: case report

  • Type of publication: preprint

  • Setting: hospitalised patient 

  • Recruitment dates: 9 February‐17 March 2020

  • Country: China

  • Language: English

  • Number of centres: 1

  • Trial registration number: NR

  • Date of trial registration: NR

Participants
  • Age: 62 years

  • Gender: female

  • Ethnicity: NR

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

  • Severity of disease: critical

  • Co‐morbidities: NR

  • Inclusion criteria: NR

  • Exclusion criteria: NR

  • Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): non‐invasive positive pressure ventilation, high‐flow oxygen therapy, Solu Medrol, Voriconazole, Sulfamethoxazole, Magnesium Isoglycyrrhizinate (MgIG), and Enoxaparin

Interventions
  • Intervention(s): CP therapy

  • Details of CP:

    • Type of plasma: NR

    • Volume: 400 mL x 2, 200m L x 5 

    • Number of doses: 5

    • Type of antibody test(s) and antibody‐titre(s): NR

    • Pathogen inactivated: 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 in a critically ill patient (on 14, 16, 24, 27 February, 2 March) 2020

  • Comparator: not applicable

  • Concomitant therapy: non‐invasive positive pressure ventilation, high‐flow oxygen therapy, Solu Medrol, Voriconazole, Sulfamethoxazole, Magnesium Isoglycyrrhizinate (MgIG), and Enoxaparin. Unclear whether these treatments were stopped before plasma transfusion or continuously given

  • Duration of follow‐up: up to 37 days (admitted 9 February‐17 March)

  • Treatment cross‐overs: not applicable

  • Compliance with assigned treatment: good 

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 (off high flow on March 5)

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

    • Admission on the ICU: reported

    • Length of stay on the ICU: NR

    • Time to discharge from hospital: reported

    • QoL: NR

  • Additional study outcomes: full blood examination, CT chest findings, inflammatory markers (IL1, IL2R, IL6, TNFalpha, IL8, IL10) 

Notes
  • Sponsor/funding: COVID‐19 Rapid Response Call from Huazhong University of Science and Technology; National Natural Science Foundation of China

  • COIs: the study authors have no potential conflicts of interest to disclose

  • Other: nil