NCT04345679.

Study name	Anti COVID‐19 convalescent plasma therapy
Methods	Trial design: phase 1, single‐arm study Sample size: 20 Setting: hospital Country: Hungary  Language: English  Number of centres
Participants	Inclusion criteria Age: > 18 years Admitted to hospital due to SARS CoV‐2 infection Written informed consent Exclusion criteria Age: < 18 years Female patients who are pregnant or breastfeeding Patients with prior allergic reaction to transfusion Patients who received in the past 30 days immunoglobulin therapy Inclusion criteria for blood donors Age: > 18 and < 60 years Body weight: > 50 kg Confirmed previous SARS CoV‐2 infection 2 negative SARS CoV‐2 test results Written informed consent Neutralising antibody titre min 1:120 Exclusion criteria for blood donors Age: < 18 or > 60 years Female patients who are pregnant HIV1/2 hepatitis B/C or syphilis infection
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP  Details of CP: type of plasma: plasmapheresis donation of 400 mL will be performed in participants who recovered from COVID‐19 and who are otherwise eligible for plasma donation, blood‐type matched volume: 200 mL number of doses: 1 antibody‐titre: NR pathogen inactivated or not: > level of 1:320 Treatment details, including time of plasma therapy (e.g. early stage of disease): NR For studies including a control group: comparator (type): none (single‐arm) Concomitant therapy: NR Treatment cross‐overs: none (single‐arm)
Outcomes	Primary study outcome: changing of viral load of SARS‐CoV2 Primary review outcomes All‐cause mortality at hospital discharge: yes  mortality (time frame: day 7, 12, 28) Time to death: yes (up to 28 days) 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: yes (duration of mechanical ventilation up to 28 days) 30‐day and 90‐day mortality: NR (up to 28 days) Admission on the ICU: yes Length of stay on the ICU: NR Time to discharge from hospital: yes QoL: NR Additional outcomes Changing of viral load of SARS‐CoV2 (time frame: day 1,3, 7, 12) Clinical status (time frame: day 7, 12, 28) clinical status assessed according to the WHO guideline Changes in immunoglobulin G COVID‐19 antibody titre (time frame: 12 days) Changes at the cytokine pattern (time frame: 12 days)
Starting date	14 April 2020
Contact information	Eszter Fodor, medical doctor; +36306640494; eszter.fodor@orthosera.com Zsombor Lacza, MD, PhD; +36305249554; zsombor.lacza@orthosera.com
Notes	Recruitment status: not yet recruiting Prospective completion date: 1 April 2021 Sponsor/funding: Orthosera Kft