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

Zhang 2020a.

Study characteristics
Methods
  • Trial design: case series

  • Type of publication: novel report in Chest journal

  • Setting: hospitals in China

  • Recruitment period: 30 January‐17 March 2020

  • Country: China 

  • Language: English 

  • Number of centres: 4

  • Trial registration number: NR (case series) 

  • Date of trial registration: NR

Participants
  • Age: 31‐73 years 

    • participant 1: 69; participant 2: 55; participant 3: 73; participant 4: 31

  • Gender: 2 male, 2 female

    • participant 1: F; participant 2: M; participant 3: M; participant 4:  F

  • Ethnicity: not stated

  • Number of participants (recruited/allocated/evaluated): 4

  • Severity of disease: critical 

  • Comorbidities: hypertension (participants 1 and 3), COPD (participant 2), chronic kidney impairment (participant 3), pregnancy (participant 4)

  • Inclusion criteria: NR

  • Exclusion criteria: NR

  • Additional diagnoses:

    • participant 1: bacterial pneumonia, fungal pneumonia, pneumorrhagia, ARDS, septic shock

    • participant 2: ARDS

    • participant 3: ARDS, renal failure, fungal pneumonia, multiple organ failure, septic shock, pneumorrhagia, cystorrhagia, GI bleeding, pneumothorax

    • participant 4: ARDS, septic shock, multiple organ failure, cardiac failure, newborn death due to asphyxia, bacterial infection

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

    • participant 1: antiviral therapy (arbidol, lopinavir‐ritonavir, interferon alpha), antibacterial therapy, antifungal therapy, supportive care, IVIG, albumin, zadaxin, mechanical ventilation

    • participant 2: antiviral therapy (arbidol, lopinavir‐ritonavir, interferon alpha 2a), noninvasive mechanical ventilation/high‐flow nasal cannula, corticosteroids (methylprednisolone) 

    • participant 3: antiviral therapy (arbidol, lopinavir‐ritonavir, interferon alpha 2b, oseltamivir, ribavirin), mechanical ventilation, renal replacement therapy, antifungal therapy (caspofungin, voriconazole), venovenous ECMO

    • participant 4: antiviral therapy (lopinavir‐ritonavir, ribavirin), mechanical ventilation, renal replacement therapy, antibacterial therapy (imipenem, vancomycin), caesarean section, venovenous ECMO

Interventions
  • CP therapy or hyperimmune immunoglobulin therapy: CP 

  • Details of CP:

    • Type of plasma: prepared from recovered patients, no other information provided

    • Volume: 200‐2400 mL 

      • participant 1: 900 mL 

      • participant 2: 200 mL 

      • participant 3: 2400 mL 

      • participant 4: 300 mL 

    • Number of doses: 1‐8 doses 

      • participant 1: 3 doses (200 mL, 400 mL, 300 mL each) 

      • participant 2: 1 dose 

      • participant 3: 8 doses (each dose not stated)

      • participant 4: 1 dose 

    • 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): days 11‐41 admission

      • participant 1: days 19, 29, 30 admission 

      • participant 2: day 11 admission

      • participant 3: day 15, 23, 27, 30, 32, 34, 38, 41 admission

      • participant 4: day 19 admission

    • For studies including a control group: comparator (type): none (not applicable) 

    • Concomitant therapy: 

      • participant 1: antiviral therapy (arbidol, lopinavir‐ritonavir, interferon alpha), antibacterial therapy, antifungal therapy, supportive care, IVIG, albumin, zadaxin, mechanical ventilation

      • participant 2: antiviral therapy (arbidol, lopinavir‐ritonavir, interferon alpha 2a), noninvasive mechanical ventilation/high‐flow nasal cannula, corticosteroids (methylprednisolone) 

      • participant 3: antiviral therapy (arbidol, lopinavir‐ritonavir, interferon alpha 2b, oseltamivir, ribavirin), mechanical ventilation, renal replacement therapy, antifungal therapy (caspofungin, voriconazole), venovenous ECMO

      • participant 4: antiviral therapy (lopinavir‐ritonavir, ribavirin), mechanical ventilation, renal replacement therapy, antibacterial therapy (imipenem, vancomycin), caesarean section, venovenous ECMO

    • Duration of follow‐up: up to 51 days 

    • Treatment cross‐overs: none

    • Compliance with assigned treatment: good (all compliant)

Outcomes
  • Primary study outcome: 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): 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: yes (extubation date reported), 15 days post‐first plasma infusion (participant 1) and 22 days post‐first plasma infusion (participant 4), participant 2 already off respiratory support prior to plasma infusion, participant 3 remained in ICU up to the time of report writing

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

    • Admission on the ICU: all in ICU at baseline 

    • Length of stay on the ICU: NR 

    • Time to discharge from hospital: 3 participants, 1  remained in ICU up to the time of report writing

    • QoL‐ NR

  • Additional study outcomes: viral load, antibody (ELISA), chest imaging results

Notes
  • Sponsor/funding: NR

  • COIs: none disclosed

  • Other: NR