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

NCT04374526.

Study name Early transfusIon of COVID‐19 convalescent plasma in elderly COVID‐19 patients to prevent disease progression
Methods

  • Trial design: randomised phase 2/3

  • Sample size: 182

  • Setting: inpatient

  • Country: Italy

  • Language: translated to English

  • Number of centres: 3
Participants Inclusion criteria:

  • Age ≥ 65

  • pneumonia at CT scan

  • PaO2/FiO2 ≥ 300 mmHg

  • Presence of ≥ 1 comorbidities (consider the list provided in Appendix A)

  • Signed informed consent


Exclusion criteria:

  • Age < 65

  • PaO2/FiO2 < 300 mmHg

  • pending cardiopulmonary arrest

  • refusal to blood product transfusions

  • Severe IgA deficiency

  • any life‐threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Interventions

  • Intervention(s): COVID‐19 CP

  • Details of CP:

    • Type of plasma: ABO‐matched pathogen‐inactivated CCP

    • Volume: 200 mL/day

    • Number of doses: 3 (days 1, 2, and 3)

    • Antibody‐titre: NR

    • Pathogen inactivated: NR

  • Treatment details, including time of plasma therapy (e.g. early stage of disease): NR

  • Comparator: standard therapy

  • Concomitant therapy: NR

  • Treatment cross‐overs: no
Outcomes

  • Primary study outcome: 

    • Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO by day 14

  • Primary review outcomes reported

    • All‐cause mortality: yes (day 28)

    • Admission to hospital: NR

  • Secondary review outcomes reported

    • Development of severe clinical COVID‐19 symptoms, defined as WHO Clinical Progression Scale ≥ 6 (WHO 2020e): NR

    • Time to symptom onset: NR

    • Clinical status, assessed by need for respiratory support with standardised scales (e.g. WHO Clinical Progression Scale, WHO Ordinal Scale for Clinical Improvement) at up to 7 days, 8 to 15 days, 16 to 30 days: yes (until day 14)

    • Mortality (time to event): NR

    • 90‐day mortality: NR

    • Length of hospital stay, for hospitalised patients: yes

    • Admission to the intensive care unit (ICU): NR

    • Viral clearance, assessed with RT‐PCR test: NR

    • QoL: NR

    • Number of participants with grade 3 and grade 4 adverse events, including potential relationship between intervention and adverse reaction (e.g. TRALI, TACO, TAD, acute transfusion reactions): NR

    • Number of participants with serious adverse events: yes

  • Additional study outcomes:

    • Decreased viral load on nasopharyngeal swab at days 6, 9 and 14

    • Decreased viraemia at days 6 and 9

    • Increased antibody titre against SARS‐CoV‐2 at days 30 and 60

    • Proportion of patients with negative of SARS‐CoV‐2 nasopharyngeal swab at day 30

    • Total plasma related adverse event (day 60)

    • Total non‐plasma related adverse events (day 60)
Starting date 27 May 2020
Contact information Raffaele Landolfi, Prof: 06 30154435 ext +39; raffaele.landolfi@unicatt.it
Luciana Teofili, Prof: 06 30154180 ext +39; luciana.teofili@unicatt.it
Notes

  • (19 January 2021) Register entry is not up to date, latest information extracted from published protocol

  • Recruitment status: recruiting

  • Prospective completion date: 30 June 2021

  •  Sponsor/funding: Fondazione Policlinico Universitario Agostino Gemelli IRCCS