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

Çınar 2020.

Study characteristics
Methods
  • Trial design: case report

  • Type of publication: journal publication

  • Setting: hospital

  • Recruitment dates: NR

  • Country: Turkey

  • Language: English

  • Number of centres: 1

  • Trial registration number: NR

  • Date of registration: NR

Participants
  • Age: 55

  • Gender: male

  • Ethnicity: NR

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

  • Severity of disease: moderate to critical

  • Co‐morbidities: myelodysplasia, disseminated systemic tuberculosis infection and kidney disease

  • Inclusion criteria: NR

  • Exclusion criteria: NR

  • Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): an antiviral drug (favipiravir), meropenem, tocilizumab, 4‐drug regimen for tuberculosis, low‐flow oxygen

Interventions
  • CP therapy or hyperimmune immunoglobulin therapy: CP therapy

  • Details of CP:

    • Type of plasma: collected using Trima Accel®Automated Blood Collection Systemfrom a donor who had previously recovered from COVID‐19 disease and met universal donation criteria.

    • Volume: 200 mL each dose

    • Number of doses: 2

    • Antibody test and antibody‐titre: anti‐SARS‐CoV‐2 IgG semi‐quantitative titre of the donor’s plasma studied by the EUROIMMUN ELISAkit (order no EI 2606‐9601 G. Produced by EUROIMMUN AG, Seekamp31, 23560 Lübeck, Germany) was positive (Titer 6.6; < 0.8 negative, ≥ 0.8 to < 1.1 borderline, ≥ 1.1 positive) 

    • 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): administered between 1 and 3 days after admission

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

  • Concomitant therapy: an antiviral drug (favipiravir), meropenem, tocilizumab, 4‐drug regimen for tuberculosis, low‐flow oxygen

  • Duration of follow‐up: up to 11 days

  • Treatment cross‐overs: not applicable

  • Compliance with assigned treatment: not applicable 

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): NR

    • Number of participants with SAEs: NR

    • 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 on the ICU: reported

    • Length of stay on the ICU: reported

    • Time to discharge from hospital: reported

    • QoL: NR

  • Additional study outcomes: NR

Notes
  • Sponsor/funding: no funding received

  • COIs: all study authors declare no competing interests

  • Other: nil

AE: adverse event; ALT: alanine aminotransferase; ARDS: acute respiratory distress syndrome; AST: aspartate transaminase; COI: conflict of interest; COPD: chronic obstructive pulmonary disease; CP: convalescent plasma; CPAP: continuous positive airway pressure; CPK: creatine phosphokinase; CRP: C‐reactive protein; CT: computed tomography; ECMO: extracorporeal membrane oxygenation; ELISA: enzyme‐linked immunosorbent assay; FiO2: fractional inspired oxygen; GI: gastrointestinal; HBV/HCV: hepatitis B/C; HLA: human leukocyte antigen; HNA: human neutrophil antigen; ICU: intensive care unit; IgA (B/G/M): immunoglobulin A (B/G/M); IL‐6: interleukin‐6; IQR: interquartile range; IRB: Institutional Review Board; IV: intravenous; IVIG: intravenous immunoglobulin; LDH: lactate dehydrogenase; MODS: multiple organ dysfunction syndrome; NR: not reported; OD: optical density; OSA: obstructive sleep apnoea; PaO2: arterial blood oxygen partial pressure; PCR: polymerase chain reaction; QoL: quality of life; RBD: receptor binding domain; RCT: randomised controlled trial; RNA: ribonucleic acid; RT‐PCR: reverse transcription polymerase chain reaction; SAE: serious adverse event; SARS: severe acute respiratory syndrome; SARS‐CoV‐2: severe acute respiratory syndrome coronavirus 2; TACO: transfusion‐associated circulatory overload; TAD: transfusion‐associated dyspnoea; TRALI: transfusion‐related acute lung injury