NCT04374526.

Study name	Early transfusIon of COVID‐19 convalescent plasma in elderly COVID‐19 patients to prevent disease progression
Methods	Trial design: randomized 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: rate of COVID‐19 progression (time frame: days 1‐14) Primary review outcomes reported All‐cause mortality at hospital discharge: NR Time to death: NR Secondary review outcomes reported 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: invasive mechanical ventilation during infection;  ECMO duration during infection: 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 Additional study outcomes: N NR
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	Recruitment status: recruiting Prospective completion date: 30 June 2021  Sponsor/funding: Fondazione Policlinico Universitario Agostino Gemelli IRCCS