Skip to main content
. 2020 Jul 10;2020(7):CD013600. doi: 10.1002/14651858.CD013600.pub2

Zeng 2020.

Study characteristics
Methods
  • Trial design: retrospective matched controlled study

  • Type of publication: journal online, ahead of print

  • Setting: ICU

  • Recruitment dates: NR

  • Country: China

  • Language: English

  • Number of centres: 2

  • Trial registration number: NR

  • Date of trial registration: NR

Participants
  • Age: median 61.5 years in CP group, median 73 years in control group

  • Gender: 5 male, 1 female in CP group; 11 males, 4 females in control group

  • Ethnicity: NR

  • Number of participants (recruited/allocated/evaluated): 21 (6 received CP, 15 in control group)

  • Severity of disease: critical (admitted to ICU)

  • Co‐morbidities: pregnancy, diabetes, hypertension, cardiovascular disease (CP group)

  • Inclusion criteria: critically ill patients 

  • Exclusion criteria: NR

  • Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): antibiotics (100%), antiviral therapy (67%), traditional Chinese medicine (50%),  IVIG (83%), steroid therapy (67%), high‐flow oxygen therapy (100%), mechanical ventilation (83%), renal replacement therapy (33%), ECMO (67%) in the CP group

Interventions
  • Intervention(s): CP therapy

  • Details of CP:

    • Type of plasma: NR

    • Volume: median 300 mL (range 200‐600mL) 

    • Number of doses: 1‐2

    • Type of antibody test(s) and antibody‐titre(s): Gold immunochromatography for SARS‐CoV‐2 IgM and IgG tests were performed using blood sample (New Coronavirus [2019‐nCoV] Antibody Detection Kit, Shanghai Outdo Biotech and Tangshan Innovita Biotech).

    • 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): critically ill patients 

  • Comparator: Not applicable

  • Concomitant therapy: antibiotics (100%), antiviral therapy (67%), traditional Chinese medicine (50%),  IVIG (83%), steroid therapy (67%), high‐flow oxygen therapy (100%), mechanical ventilation (83%), renal replacement therapy (33%), ECMO (67%) in the CP group. Unclear whether these treatments were stopped before plasma transfusion or continuously given

  • Duration of follow‐up: NR

  • Treatment cross‐overs: Not applicable

  • Compliance with assigned treatment: good (all compliant)

Outcomes
  • Primary study outcome(s):  survival 

  • Primary review outcomes

    • All‐cause mortality at hospital discharge: reported (5 of 6 patients died)

    • Time to death: reported 

  • 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: NR

    • 30‐day and 90‐day mortality: reported

    • Admission on the ICU: reported (all admitted)

    • Length of stay on the ICU: NR

    • Time to discharge from hospital: reported (1 discharged)

    • QoL: NR

  • Additional study outcomes: duration of viral shedding  

Notes
  • Sponsor/funding: supported by The National Natural Science Foundation of China (No. 81970517), Zhongyuan (Henan) Thousands Outstanding Talents Plan (No. ZYQR201912179), Foundation for Distinguished Young Talents of Zhengzhou University Medical School (No.2020ZQLMS), and The Key Scientific Research Project of Henan Higher Education Institutions of China (No. 20B320028).

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

  • Other: written informed consents were obtained from all the family members of patients who received plasma.