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. 2021 May 20;2021(5):CD013600. doi: 10.1002/14651858.CD013600.pub4

NCT04442958.

Methods

  • Trial design: randomised cross‐over

  • Sample size: 60

  • Setting: severe with ARDS

  • Country: Turkey

  • Language: English

  • Number of centres: 1

  • Trial registration number: NCT04442958

  • Date of registration:  23 June 2020
Participants

  • Inclusion criteria

    • Clinical diagnosis of COVID‐19

  • Exclusion criteria

    • < 18

    • Lower plasma IgA levels

    • PaO2/FiO2 > 300 mmHg

    • SpO2 > 90

  • Donor eligibility criteria: NR

  • Donor exclusion criteria: NR
Interventions

  • Intervention(s): CP therapy

  • Details of CP

    • Type of plasma: CP

    • Volume: 200 mL

    • Number of doses: 1

    • Antibody test and antibody‐titre: neutralising antibody titres above 1:640

    • Pathogen inactivated or not: NR

    • RT‐PCR tested: NR

  • Details of donors:

    • Gender: NR

    • HLA and HNA antibody: NR

    • Severity of disease: NR

    • Timing from recovery from disease: NR

  • Treatment details, including time of plasma therapy (e.g. early stage of disease): severe patients with ARDS

  • Comparator: standard care

  • Concomitant therapy: NR

  • Duration of follow‐up: NR

  • Treatment cross‐overs: NR
Outcomes

  • Primary study outcomes (time frame: 7 days)

    • Plasma ferritin level

    • Lymphocyte count 

    • D‐dimer level 

    • CRP level 

    • Plasma procalcitonin level 

    • Plasma fibrinogen level 

  • Primary review outcomes 

    • All‐cause mortality at hospital discharge: NR

    • Time to death: NR

  • 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: NR

    • WHO ordinal scale: NR

    • 30‐day and 90‐day mortality: NR

    • Admission on the ICU: NR

    • Length of stay on the ICU: NR

    • Time to discharge from hospital: NR

    • QoL: NR

    • Virological response: NR

  • Additional outcomes (time frame: 7 days)

    • FiO2 level 

    • PaO2 level 

    • Arterial oxygen level 
Notes

  • Recruitment status: completed

  • Prospective completion date: 17 June 2020

  • Sponsor/funding: Bagcilar Training and Research Hospital