NCT04374370.

Study name	Severe acute respiratory syndrome coronavirus 2 of the genus betacoronavirus (SARSCoV2) convalescent plasma (CP) expanded access protocol (EAP)
Methods	Trial design: intermediate‐size population, expanded access  Sample size: NR Setting: inpatient Country: USA Language: English Number of centres: NR
Participants	Inclusion criteria: Ages ≥ 6 years Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 18 years of age); or willing and able to provide assent as required per Institutional Review Board (IRB) prior to performing study procedures Must have laboratory‐confirmed COVID‐19‐positive test Must have severe or immediately life‐threatening COVID‐19 Severe disease is defined as: 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 is defined as: respiratory failure septic shock, and/or multiple organ dysfunction or failure Exclusion criteria: Known contraindication to transfusion or history of prior reactions to transfusion of blood products
Interventions	Intervention(s): SARS‐CoV2 CP Details of CP: Type of plasma: SARS‐CoV2 CP Volume: NR Number of doses: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR Comparator: NR Concomitant therapy: NR Treatment cross‐overs: no
Outcomes	Primary study outcome: NR Primary review outcomes reported All‐cause mortality at hospital discharge: NR 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: invasive mechanical ventilation during infection;  ECMO duration during infection 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 study outcomes NR
Starting date	NR
Contact information	Contact: Chris Ensor, Pharm D 413.519.7056 Chris.Ensor@AdventHealth.com
Notes	Recruitment status: available Prospective completion date: NR  Sponsor/funding: AdventHealth Orlando, Available: Orlando, Florida, United States, 32803, Principal Investigator: Eduardo Oliveira, MD AdventHealth