NCT04358211.

Study name	Expanded access to convalescent plasma to treat and prevent pulmonary complications associated with COVID‐19
Methods	Trial design: single‐arm feasibility study, expanded access‐ compassionate use Sample size: NR‐ intermediate‐size population Setting: inpatient Country: USA Language: English Number of centres: NR
Participants	Inclusion criteria All sexes ≥ 18 years COVID‐19 confirmed via SARS‐CoV‐2 RT‐PCR testing Population1 Associated severe pulmonary complications‐hospitalised and intubated in the ICU with COVID‐19 respiratory symptoms Written informed consent and comply with all protocol requirements, or requirement for informed consent is waived due to the inability to communicate with the patient and unable to identify LAR Consents to storage of specimens for future testing, or consent waived The requirements to waive a consent are delineated in 21 CFR 50.23 and will be followed Pregnant and breastfeeding women will not be excluded from the study Population 2 Coronavirus‐associated complications in hospitalised patient with COVID‐19 respiratory symptoms Hospitalised within 3‐7 days from the beginning of illness Patient is willing and able to provide written informed consent and comply with all protocol requirements Patient agrees to storage of specimens for future testing Exclusion criteria Population 1: Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products). Severe multi‐organ failure with expected life expectancy < 24 h as determined by the treating physician Population 2: Female participants with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period Receipt of pooled immunoglobulin in past 30 days Contraindication to transfusion or history of prior reactions to transfusion blood products
Interventions	Intervention(s): CP Details of CP: Type of plasma: ABO‐compatible SARS‐CoV‐2 CP Volume: 200‐400 mL Number of doses: 1‐2 units Antibody‐titre: >1:160 (a moving target as assays develop) Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease) Population 1: intubated, mechanically ventilated patients with confirmed COVID‐19 pneumonia by chest X‐ray or chest CT Population 2: hospitalised patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms, with COVID‐19 Comparator: N/A Concomitant therapy: NR Treatment cross‐overs: yes/ no
Outcomes	Primary study outcome(s): 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 adverse events, including potential relationship between intervention and adverse reaction (e.g. TRALI, transfusion‐transmitted infection, TACO, TAD, acute transfusion reactions): 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 to 30 days: NR 30‐day and 90‐day mortality: NR Admission on ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Additional outcomes: NR
Starting date	April 3 2020
Contact information	Nakhle Saba, MD nsaba@tulane.edu Tulane Medical CenterAvailable New Orleans, Louisiana, USA, 70112
Notes	Recruitment status: expanded access, available. Prospective completion date: NR Sponsor/funding: Nakhle Saba, MD. Tulane