NCT04343261.

Study name	Convalescent plasma in the treatment of COVID 19
Methods	Trial design: single‐arm intervention study  Sample size: 15 Setting: hospital  Country: USA Language: English Number of centres: 1
Participants	Inclusion criteria All genders Age > 18 years and < 90 years Must have laboratory‐confirmed COVID‐19 Must provide informed consent Must have severe or immediately life‐threatening COVID‐19 Exclusion criteria No gender exclusion Age < 18 years and > 90 years COVID‐19‐negative
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP  Details of CP: type of plasma: NR volume: 2 units (mL NR) number of doses: NR antibody‐titre: NR pathogen inactivated or not: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): severe or life‐threatening  For studies including a control group: comparator (type): none (single‐arm) Concomitant therapy: NR Treatment cross‐overs: not applicable
Outcomes	Primary study outcome: mortality within 28 days, viral load, serum antibody titers  Primary review outcomes All‐cause mortality at hospital discharge: yes (within 28 days) Time to death: yes (within 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: NR 30‐day and 90‐day mortality: NR (within 28 days only) Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Additional outcomes:  Reduction of viral load Change in serum antibody titres
Starting date	10 April 2020
Contact information	Contact: Latha Dulipsingh, MD860‐714‐4402; Latha.Dulipsingh@trinityhealthofne.org
Notes	Recruitment status: not yet recruiting  Prospective completion date: 1 April 2021 Sponsor/funding: Saint Francis Care