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

Ye 2020.

Study characteristics
Methods
  • Trial design: case series

  • Type of publication: preprint

  • Setting and dates: inpatient

  • Recruitment period: 31 January 2020‐22 March 2020

  • Country: China 

  • Language: English 

  • Number of centres: 1

  • Trial registration number: NR

  • Date of trial registration: NR

Participants
  • Age: 28‐75 years (participants 1‐6: 69, 75, 56, 63, 28, 57)

  • Gender: 3 male, 3 female (participants 1‐6: M, F, M, F, F, M)

  • Ethnicity: NR 

  • Number of participants (recruited/allocated/evaluated): 6

  • Severity of disease: critical (note: participant 5 was not critically ill), late course of disease, laboratory values mostly normal

  • Comorbidities: bronchitis and Sjogren's in participants 3 and 4, none in other participants

  • Inclusion criteria: (1) laboratory‐confirmed cases; (2) patients with abnormalities in chest CT (participant 5 was an exception); (3) patients with deteriorated symptoms after standard treatment; (4) patients with persistent positive result of throat swab; (5) critically ill patients

  • Exclusion criteria: (1) patients allergic to plasma contents; (2) patients positive for HBV, HCV and HIV; (3) patients with uncontrolled bacterial mixed infection; (4) patients with malignant tumours; (5) patients who developed MODS

  • Additional diagnoses: none 

  • Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): oxygen therapy (nasal) in 4 participants, antiviral therapy (arbidol in all participants), antibiotics (levofloxacin in 1 participant)

Interventions
  • CP therapy or hyperimmune immunoglobulin therapy: CP

  • Details of CP:

    • Type of plasma: ABO‐compatible CP

    • Volume: 200 mL 

    • Number of doses: ≥ 1 (ranges 1‐3; participants 1‐6: 3, 2, 3, 1, 1, 1) 

    • Antibody‐test and antibody‐titre: anti‐SARS‐CoV‐2 IgM and IgG

    • Pathogen inactivated or not: NR 

    • RT‐PCR tested: free of residual SARS‐CoV‐2 by real time PCR

  • Details of donors: 

    • Gender: NR

    • HLA and HNA antibody‐negative: NR

    • Severity of disease: NR

    • Timing from recovery from disease: an afebrile status for at least 3 days; at least 3 weeks following disease onset

    • RT‐PCR tested: negative for SARS‐CoV‐2 nucleic acid for consecutive two RT‐PCR tests

  • Treatment details, including time of plasma therapy (e.g. early stage of disease): critically ill participants in later stages of infection 

    1. admission to study centre on 7 February, first transfusion on 10 March, repeated transfusions on 13 and 16 March

    2. admission to study centre on 12 February, first transfusion on 5 March, repeated transfusion on 9 March

    3. admission to study centre on 12 February, first transfusion on 5 March, repeated transfusion on 6 and 9 March

    4. admission to study centre on 11 February, first transfusion on 10 March

    5. admission to study centre on 5 March, first transfusion on 13 March

    6. admission to study centre on 12 March, first transfusion on 18 March

  • For studies including a control group: comparator (type): none

  • Concomitant therapy: oxygen therapy, antiviral therapy (arbidol in all participants), antibiotics (levofloxacin in 1 participant)

  • Duration of follow‐up: up to discharge (5 participants; 1 further monitored after negative swab tests (follow‐up unclear))

  • Treatment cross‐overs: none

  • Compliance with assigned treatment: good (all compliant)

Outcomes
  • Primary study outcome:

    • Improvement in symptoms and chest CT in the following days after indicated intervention

  • 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: reported, none occurred (3‐day follow‐up)

    • Number of participants with SAEs: reported, none occurred (3‐day follow‐up)

    • Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: specific time of recovery NR

    • 30‐day and 90‐day mortality: reported (all alive and time point not reached) 

    • Admission on the ICU: none admitted to ICU

    • Length of stay on the ICU: reported, none admitted to ICU

    • Time to discharge from hospital: reported in 5 participants, range 10‐34 days, 1 further monitored after negative swab tests (follow‐up unclear)

    • QoL: NR

  • Additional study outcomes:  Blood and swab samples were obtained to measure serum anti‐SARS‐CoV‐2 IgM and IgG titres and throat SARS‐CoV‐2 nucleic acid, respectively

Notes
  • Sponsor/funding: "this study was partially sponsored by grants National Natural Science Foundation of China (#81802301 to Mingxiang Ye, #81772500 to Tangfeng Lv), and Jiangsu Provincial Key Research and Development Program (BE2018713 to Xinyi Xia)."

  • COIs: study authors declare no competing interests

  • Other: "this study was reviewed and approved by the Medical Ethical Committee of Wuhan Huoshenshan Hospital. Written informed consent was obtained from each participant. The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding authors had full access to all the data in the study and had final responsibility for the decision to submit for publication."