NCT04363034.

Study name	Arkansas expanded access COVID‐19 convalescent plasma treatment program
Methods	Trial design: expanded access treatment protocol following standard institutional procedures Sample size: up to 100 (intermediate‐size population) Setting: inpatient Country: USA Language: English Number of centres: NR
Participants	Inclusion criteria All sexes ≥ 18 years Laboratory‐confirmed COVID‐19 via SARS‐CoV‐2 RT‐PCR testing Patients currently hospitalised with severe or life‐threatening COVID‐19 or patients the treating physician deems to be at high‐risk for progressing to severe or life‐threatening COVID‐19 Severe disease, defined as ≥ 1 of the following: dyspnoea respiratory frequency ≥ 30/min blood oxygen saturation ≤ 93% partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24‐48 h Life‐threatening disease, defined as ≥ 1 of the following: respiratory failure septic shock, and/or multiple organ dysfunction or failure Informed consent from patients/LAR Exclusion criteria Female patients with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period Patients who have received pooled immunoglobulin in past 30 days Contraindication to transfusions or history of prior reactions to transfusion blood products
Interventions	Intervention(s): COVID‐19 CP Details of CP: Type of plasma: ABO‐compatible, low isohemagglutinin titre Volume: 200‐400 mL per unit, not to exceed 550 mL total Number of doses: 1‐2 units (rate of 100 to 250 mL/h) within 4 h Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): participants with severe or life‐threatening, laboratory‐confirmed COVID‐19 Comparator: N/A Concomitant therapy: premedications (e.g. acetaminophen, diphenhydramine, etc.) as necessary Treatment cross‐overs: N/A
Outcomes	Primary study outcome(s): NR Primary review outcomes reported All‐cause mortality at hospital discharge: (give details e.g. 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): Number of participants with SAEs: no Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8 ‐15 days; 16 to 30 days: no 30‐day and 90‐day mortality: Admission on ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR Additional outcomes: NR
Starting date	27 April 2020
Contact information	Danielle Evans (501) 526‐7906 DEvans@uams.edu David Avery (501) 214‐2101 daavery@uams.edu University of Arkansas
Notes	Recruitment status: expanded access ‐ available Prospective completion date: NR Sponsor/Funding: University of Arkansas