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

Zhang 2020b.

Study characteristics
Methods
  • Trial design: case report

  • Type of publication: open‐access article

  • Setting: inpatient/ICU

  • Recruitment period: NR

  • Country: China

  • Language: English 

  • Number of centres: 1

  • Trial registration number: NR (case report) 

  • Date of trial registration: NR

Participants
  • Age: 64 years

  • Gender: female

  • Ethnicity: NR

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

  • Severity of disease: severe

  • Comorbidities: hypertension, diabetes

  • Inclusion criteria: NR

  • Exclusion criteria: NR

  • Additional diagnoses: NR

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

Interventions
  • CP therapy or hyperimmune immunoglobulin therapy: CP 

  • Details of CP:

    • Type of plasma: IgM reactive plasma; free of hepatitis B and C virus, HIV, syphilis, and residual SARS‐CoV‐2

    • Volume: 200 mL

    • Number of doses: unclear

    • Type of antibody test and antibody‐titre: IgG titrated by semiquantitative ELISA: 1:1: 6.59; 1:10: 5.33; 1:20: 4.87; 1:40: 3.87; 1:80: 3.24; 1:160: 2.20; 1:320: 2.17/> 1:160

    • Pathogen inactivated or not: NR

    • RT‐PCR tested: NR

  • Details of donors: 

    • Gender: 4 male, 2 female,

    • HLA and HNA antibody‐negative: NR

    • Severity of disease: laboratory‐confirmed SARS‐CoV‐2 infection

    • Timing from recovery from disease: NR

    • RT‐PCR tested: recovery certificated by 2 consecutively negative SARS‐CoV‐2 PCR assay

  • Treatment details, including time of plasma therapy (e.g. early stage of disease): 1 week after admission to ICU

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

  • Concomitant therapy: NR

  • Duration of follow‐up:  11 days after transfusion; then transferred to general ward

  • Treatment cross‐overs: none

  • Compliance with assigned treatment: good (compliant), transferred to general ward

Outcomes
  • Primary study outcome: antibody levels in CP

  • 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): none

    • Number of participants with SAEs: none

    • Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: reported for day 11

    • 30‐day and 90‐day mortality: NR (all alive)

    • Admission on the ICU: reported 

    • Length of stay on the ICU: reported 

    • Time to discharge from hospital: remains on general ward

  • Additional study outcomes: lymphocyte count, renal and liver function, prothrombin time, CPK, LDH and myocardial enzymes

Notes
  • Sponsor/funding: "this study was supported by Medical Science and Technology Development Foundation, Nanjing Department of Health (ZKX18050). Dr. Xiang Xue is supported by the National Institutes of Health (K01DK114390) and a Research Scholar Grant from the American Cancer Society (RSG‐18‐050‐01‐NEC)."

  • COIs: declared to have no conflicts of interest

  • Other: case series focusing on CP donors