NCT04355767.

Study name	Convalescent plasma to limit coronavirus associated complications: a randomized double‐blind, phase 2 study comparing the efficacy and safety of high‐titer anti‐SARS‐CoV‐2 plasma vs. placebo in emergency room patients
Methods	Trial design: RCT Sample size: 206 Setting: patients presenting to ED Country: USA Language: English Number of centres: 1
Participants	Inclusion criteria Age ≥ 18 years old Patients requiring clinical evaluation in the ED but who do not require hospital admission Patients who are within 14 days since the onset of COVID‐19 symptoms and are confirmed to have the disease via COVID‐19 SARS‐CoV‐2 RT‐PCR testing or rapid RNA assay Patient agrees to storage of specimens for future testing Exclusion criteria Women who are pregnant or breastfeeding Received pooled immunoglobulin in the past 30 days Contraindication to transfusion or history of prior reactions to transfusion blood products
Interventions	CP therapy or hyperimmune globulin therapy: CP Details of CP: type of plasma: CP, other details not provided volume: 200‐600 mL number of doses:1‐2 antibody‐titre: > 1:80 pathogen inactivated or not: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): within 14 days' onset of disease For studies including a control group: comparator (type): normal plasma  Concomitant therapy: NR Treatment cross‐overs: none
Outcomes	Primary study outcome: time to disease progression Primary review outcomes All‐cause mortality at hospital discharge: NR Time to death: NR 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 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 Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Additional outcomes Time to disease progression (time frame: 15 days) Change in symptom severity over time (time frame: 15 days)
Starting date	May 2020
Contact information	Study team; 650‐724‐7186; jcunning@stanford.edu
Notes	Recruitment status: not yet recruiting  Prospective completion date: December 2022 Sponsor/funding: Stanford University