NCT04344535.

Study name	Convalescent plasma to reduce complications associated with COVID‐19 infection: a randomized trial comparing the efficacy and safety of high‐titre anti‐SARS‐CoV‐2 plasma vs. standard plasma in hospitalized patients with COVID‐19 infection
Methods	Trial design: randomised phase 1/2 Sample size: 500 Setting: hospital Country: USA Language: English Number of centres: 1
Participants	Inclusion criteria Adults ≥ 18 years Hospitalised with PCR+ COVID‐19 infection If female must not be pregnant and/or breastfeeding Exclusion criteria Unable to randomise patient within 14 days of admission to Stony Brook Hospital (or any other hospital if a transfer to Stony Brook Hospital) In the treating physician's opinion, the patient cannot tolerate a 450‐550 mL infusion of plasma over up to 8 h (4 h max per unit), even if prophylaxed with IV diuretic Contraindication to transfusion or history of prior reactions to blood transfusions Inclusion criteria for plasma recipients Adults ≥ 18 years Hospitalised with PCR‐positive COVID‐19 infection If female must not be pregnant and/or breastfeeding
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP  Details of CP: type of plasma: CP, specific preparation NR volume: 450‐550 mL number of doses: 2 antibody‐titre: ideally > 1:320, but meeting minimum titre per FDA Guidelines for CP pathogen inactivated or not: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): within 14 days of hospitalisation  For studies including a control group: comparator (type): 450‐550 mL of plasma with low titre to anti‐SARS‐CoV‐2 antibodies (standard plasma) Concomitant therapy: NR Treatment cross‐overs: none
Outcomes	Primary study outcome: number of days patient remains ventilator‐free (up to 28 days) Primary review outcomes All‐cause mortality at hospital discharge: yes (90‐day all‐cause mortality) Time to death: yes 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 30‐day and 90‐day mortality: yes Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Additional outcomes: number of days patient remains ventilator‐free (up to 28 days)
Starting date	8 April 2020
Contact information	Contact information not shared Responsible party: Elliott Bennett‐Guerrero, Professor of Anesthesiology, Stony Brook University
Notes	Recruitment status: enrolling by invitation Prospective completion date: 31 August 2021 Sponsor/funding: Stony Brook University