NCT04340050.

Study name	Pilot study for use of convalescent plasma collected from patients recovered from COVID‐19 disease for transfusion as an empiric treatment during the 2020 pandemic at the University of Chicago Medical Center
Methods	Trial design: single‐arm, phase I, intervention study Sample size: 10 Setting: hospital Country: USA Language: English Number of centres: 1
Participants	Inclusion criteria ≥ 18 years Laboratory‐confirmed COVID‐19 Severe or immediately life‐threatening COVID‐19. (Severe defined as dyspnoea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, PaO2/FiO2 < 300, and/or lung infiltrates > 50% within 24‐ 48 h. Life‐threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from CP therapy) Must be < 21 days from the start of illness Written informed consent, willingness to comply with all protocol requirements, agreement to storage of specimens for future testing from patient or power of attorney or a healthcare proxy Exclusion criteria 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 Patients currently enrolled in other drug trials that preclude investigational treatment with anti‐SARS‐CoV‐2 CP
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP therapy Details of CP: type of plasma volume: 300 mL number of doses: 1 antibody‐titre pathogen inactivated or not: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): must be < 21 days from the start of illness For studies including a control group: comparator (type): not applicable Concomitant therapy: NR Treatment cross‐overs: not applicable
Outcomes	Primary study outcome: feasibility of performing study pathway, type of respiratory support Primary review outcomes All‐cause mortality at hospital discharge: yes 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: NR Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: yes 30‐day and 90‐day mortality: NR Admission on the ICU: yes Length of stay on the ICU: yes Time to discharge from hospital: yes QoL: NR Additional outcomes Feasibility of performing study pathway consisting of consenting convalescent donors, harvesting CP, application for FDA emergency investigational new drug use for administering CP to the patients Type of respiratory support defined as room air, high‐flow oxygen, intubation Cardiac arrest Time to transfer to ICU ICU mortality
Starting date	10 April 2020
Contact information	Maria Lucia Madariaga, MD; 773‐270‐2004; mlmadariaga@bsd.uchicago.edu
Notes	Recruitment status: active, not recruiting Prospective completion date: 31 December 2021 Sponsor/funding: NR