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

Ahn 2020.

Study characteristics
Methods
  • Trial design: case series

  • Type of publication: journal publication

  • Setting: ICU

  • Recruitment dates: 22 February 2020‐29 March 2020

  • Country: South Korea

  • Language: English

  • Number of centres: 1

  • Trial registration number: NR

  • Date of trial registration: NR

Participants
  • Age: 67 and 71

  • Gender: 1 male, 1 female

  • Ethnicity: NR

  • Number of participants (recruited/allocated/evaluated): 2

  • Severity of disease: critical

  • Co‐morbidities: case 2 ‐ medical history of hypertension

  • Inclusion criteria: NR

  • Exclusion criteria: NR

  • Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): 400 mg of hydroxychloroquine once daily and lopinavir/ritonavir 400 mg/100 mg twice daily, empirical antibiotics, 4 L/min oxygen flow via nasal cannula, high‐flow oxygen therapy

Interventions
  • Intervention(s): CP therapy

  • Details of CP:

    • Type of plasma: apheresis plasma, collected with Spectra Optia apheresis system (CMNC software; Spectra Optia IDL Tubing set; Terumo BCT, Lakewood, CO, USA)

    • Volume: 500 mL total

    • Number of doses: 2

    • Type of antibody test(s) and antibody‐titre(s): anti‐SARS‐CoV‐2 IgG antibody in plasma was measured by ELISA (Novel Coronavirus COVID‐19 IgG ELISA kit; Epitope Diagnostics, San Diego, CA, USA) and OD ratio for IgG

    • Pathogen inactivated: NR

    • RT‐PCR tested: NR

  • Details of donors: 

    • Gender: male

    • HLA and HNA antibody‐negative: NR

    • Severity of disease: pneumonia

    • Timing from recovery from disease: 18‐21 days

    • RT‐PCR tested: yes in 1 participant 

  • Treatment details, including time of plasma therapy (e.g. early stage of disease): administered 7 (case 2) and 22 (case 1) days after admission

  • Comparator: not applicable

  • Concomitant therapy: 400 mg of hydroxychloroquine once daily and lopinavir/ritonavir 400 mg/100 mg twice daily, empirical antibiotics, intubation and mechanical ventilator care, IV methylprednisolone (0.5/1 mg/kg/day daily). Unclear whether these treatments were stopped before plasma transfusion or continuously given

  • Duration of follow‐up: up to 26 days

  • Treatment cross‐overs: not applicable

  • Compliance with assigned treatment: good (all compliant)

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): reported

    • Number of participants with SAEs: reported

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

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

    • Admission to the ICU: reported

    • Length of stay on the ICU: reported

    • Time to discharge from hospital: reported

    • QoL: NR

  • Additional study outcomes: SARS‐CoV‐2 RNA by rRT‐PCR, IL‐6 and CRP, white blood cell count, lymphocyte count, arterial blood gas analysis (PaO2/FiO2), chest X‐ray, overall improvement of clinical symptoms

Notes
  • Sponsor/funding: funding was provided by: Ministry of Health and Welfare (HI14C1324), Korea HIV/AIDS Cohort Study (2019‐ER5101‐00)

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

  • Other: "this study was approved by the IRB of Severance Hospital (IRB No. 4‐2020‐0076) and with participants' written informed consent. The images are published under agreement of the patients."