NCT04385199.

Study name	The use of convalescent plasma for patients hospitalized with COVID‐19 disease
Methods	Trial design: open, parallel, RCT Sample size: 30 Setting: inpatient Country: USA Language: English Number of centres: 1
Participants	Inclusion criteria age > 18 with ≥ 1 of the following: dyspnoea respiratory rate ≥ 30 breaths/min Oxygen saturation ≤ 93% PaO2/FiO2 < 300 bilateral airspace opacities on chest radiograph at 24‐48 h Exclusion criteria Acute myocardial infarction in past 30 days Acute stroke in past 30 days VV ECMO VA ECMO
Interventions	Intervention(s): conventional treatment and CP therapy Details of CP: Type of plasma: ABO‐compatible CP Volume: 200 mL Number of doses: 1 Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): hospitalised patients  Comparator: conventional treatment Concomitant therapy: NR Treatment cross‐overs: no
Outcomes	Primary study outcome: improvement in respiratory disease (time frame: days 1, 3, 5, 7, 14, 28 post‐transfusion)  For intubated participants improvement in PaO2/FiO2  For non‐intubated participants time to intubation post‐transfusion 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): yes  Number of participants with SAEs: yes 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 study outcomes: radiographic improvement (Time frame: 3, 28 days post transfusion)
Starting date	4 May 2020
Contact information	Geneva Tatem, MD313‐587‐6775, gtatem1@hfhs.org
Notes	Recruitment status: recruiting Prospective completion date: 1 August 2020 Sponsor/funding: Henry Ford Health System