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

NCT04418518.

Study name	CONCOR‐1: a randomized open‐label trial of convalescent plasma for hospitalized adults with acute COVID‐19 respiratory illness
Methods	Trial design: randomised Sample size: 1200 Setting: hospitalised patients Country: USA Language: English Number of centres: 3 Trial registration number: NCT04418518 Date of registration: 5 June 2020
Participants	Inclusion criteria: ≥ 18 years old Admitted to hospital with confirmed COVID‐19 respiratory illness Receiving supplemental oxygen 500 mL of ABO compatible convalescent plasma is available Exclusion criteria: Onset of symptoms > 12 days prior to randomisation Intubated or plan for intubation in place Plasma is contraindicated (e.g. history of anaphylaxis from transfusion) Decision in place for no active treatment Donor eligibility criteria: NR Donor exclusion criteria: NR
Interventions	Intervention(s): CP therapy Details of CP: Type of plasma: CP Volume: 500 mL Number of doses: 1 (or 2 x 250 ml) Antibody test and antibody‐titre: NR Pathogen inactivated or not: NR RT‐PCR tested: NR Details of donors: Gender: NR HLA and HNA antibody: NR Severity of disease: NR Timing from recovery from disease: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): hospitalised patients Comparator: nil Concomitant therapy: standard of care Duration of follow‐up: 90 days Treatment cross‐overs: nil
Outcomes	Primary study outcome: Intubation or death in hospital Primary review outcomes reported All‐cause mortality at hospital discharge: reported Time to death: reported 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: reported Number of participants with SAEs: reported Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: reported WHO ordinal scale: NR 30‐day and 90‐day mortality: reported Admission on the ICU: reported Length of stay on the ICU: reported Time to discharge from hospital: reported QoL: NR Virological response: NR Additional outcomes: need for intubation, time of intubation, need for renal replacement therapy, development of myocarditis
Starting date	24 June 2020
Contact information	Celine Arar: 212‐746‐4177; cea4002@med.cornell.edu
Notes	Recruitment status: recruiting Prospective completion date: December 2021 Sponsor/funding: Weill Medical College of Cornell University