NCT04365439.

Study name	Convalescent plasma for the treatment of moderate‐severe COVID‐19: a proof‐of‐principle study
Methods	Trial design: proof of concept study, single‐group assignment, open‐label Sample size: 10 Setting: e.g. inpatient Country: Italy Language: Engllish Number of centres: NR
Participants	Inclusion criteria All sexes Hospitalised adult patients 18‐75 years Confirmed COVID‐19 infection by nasopharyngeal swab Radiologically confirmed pneumonia SpO2 > 92% and < 96% (room air) ongoing thromboembolic prophylaxis Exclusion criteria Participation to another COVID‐19 trial severe COVID‐19 disease (SpO2 < 93% in room air) severe allergic transfusion reactions or anaphylaxis in the patient history documented lgA deficiency unstable heart disease with signs of circulatory overload malignancies or other concomitant diseases with poor short‐term prognosis pregnancy
Interventions	Intervention(s): CP from patients after COVID‐19 Details of CP: Type of plasma: NR Volume: NR Number of doses: NR Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): patients with moderate to severe COVID‐19 Comparator: N/A Concomitant therapy: thromboembolic prophylaxis Treatment cross‐overs: N/A
Outcomes	Primary study outcome(s): Titres of anti‐SARS‐CoV‐2 antibodies in the plasma derived from CP donors (time frame: at plasma donation) Change in titres of anti‐SARS‐CoV‐2 antibodies in patients' plasma (time frame: change from baseline at day 21) Change in inflammatory cytokines concentration (e.g. IL‐6, HMGB1) (time frame: change from baseline at day 7) Viral load decay in the recipient after plasma transfusion with semiquantitative assessment of nasopharyngeal swabs (time frame: change from day of diagnosis at day 1) Primary review outcomes reported All‐cause mortality at hospital discharge: Time to death: yes within the 7‐point ordinal scale (time frame: at day 7). 7‐point ordinal scale measure on day 0 (baseline), day 1, 3 and 7 after plasma transfusion 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): yes Proportion of participants with AEs, severity of AEs (time frame: at day 21) AE will be assessed by the DAIDS scale on day 1, 3, 7 and 21. Relatedness with plasma transfusion will also be reported. Number of participants with SAEs: yes Proportion of participants with AEs, severity of AEs (time frame: at day 21) AE will be assessed by the DAIDS scale on day 1, 3, 7 and 21.  Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: yes within the 7‐point ordinal scale (time frame: at day 7). 7‐point ordinal scale measure on day 0 (baseline), day 1, 3 and 7 after plasma transfusion 30‐day and 90‐day mortality: no Admission on ICU: yes  within 7‐point ordinal scale Length of stay on the ICU: yes within 7‐point ordinal scale up to day 7 Time to discharge from hospital: yes within 7 point ordinal scale QoL: NR Additional outcomes: NR
Starting date	27 April 2020
Contact information	Contact: Enos Bernasconi, M.D. +41 91 811 60 22  enos.bernasconi@eoc.ch Contact: Beatrice Bernasconi +41 91 811 60 21 beatrice.bernasconi@eoc.ch Ente Ospedaliero Cantonale, Bellinzona Principal Investigator: Stefano Fontana, M.D. Servizio Trasfusionale, Lugano
Notes	Recruitment status: not yet recruiting Prospective completion date:  23 June 2020 Sponsor/Funding: Enos Bernasconi, Ente Ospedaliero Cantonale, Bellinzona