NCT04392232.

Study name	A phase 2 study of COVID 19 convalescent plasma in high risk patients with COVID 19 infection
Methods	Trial design: single‐arm intervention Sample size: 100 Setting: inpatient Country: USA Language: English Number of centres: 2
Participants	Inclusion criteria Participants will be ≥ 16 years COVID‐19 infection demonstrated via SARS‐CoV‐2 PCR testing Admitted to the hospital for treatment of COVID‐19. Patients must have severe/high risk disease as defined by the presence of any one of the following: Respiratory frequency ≥ 25/min Oxygen saturation ≤ 93% on room air Partial pressure of arterial oxygen to fraction of inspired oxygen ration < 300, or pulse oximetric saturation to fraction of inspired oxygen ratio < 315 Lung infiltrates > 50% within 24‐48 h of admission on Chest X‐Ray or, Ferritin > 1000 or absolute lymphocyte count < 600 or D‐Dimer > 1.00 ABO blood type available Pregnant women will be permitted to participate in this study. Exclusion criteria Previous history of life‐threatening or severe adverse reactions to transfusion blood products
Interventions	Intervention(s): CP therapy Details of CP: Type of plasma: FDA‐registered blood establishment (Hoxworth) that follows donor eligibility criteria and donor qualifications as outlined in section III.C.I of the Investigational COVID‐19 CP Guidance for Industry Volume: NR Number of doses: NR Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR Comparator: not applicable Concomitant therapy: NR Treatment cross‐overs: not applicable
Outcomes	Primary study outcome: Survival rate (at 28 days) Primary review outcomes reported All‐cause mortality at hospital discharge: 28‐day mortality Time to death: NR 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): 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: yes (28‐day mortality) Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Additional study outcomes: none
Starting date	5 May 2020
Contact information	William Judd, MBA, MHA (C.)  513 865 5020 William_Judd@TriHealth.com
Notes	Recruitment status: recruiting Prospective completion date: 31 December 2020 Sponsor/funding: TriHealth Inc