NCT04355897.

Study name	CoVID‐19 plasma in treatment of COVID‐19 patients
Methods	Trial design: single‐arm intervention study Sample size: 100 Setting: hospital Country: USA Language: English Number of centres: 1
Participants	Inclusion criteria Age 18‐80 years Symptomatic CoVID‐19 disease requiring hospitalisation SARS‐CoV‐19 PCR positive Elevated high‐sensitivity troponin Exclusion criteria Multi‐organ/system failure Renal insufficiency (estimated GFR < 30 or renal replacement therapy) Liver dysfunction (> 3 x ULN serum glutamic oxaloacetic transaminase/serum glutamate pyruvate transaminase) Chronic immunosuppression therapy Prior organ transplant Prior multiple transfusions for myelodysplastic syndrome Prior treatment with plasma, immunoglobulin transfusion within 30 days Allergic reaction to blood/ plasma products Pregnant or breast feeding at the time of study Inability to provide informed consent
Interventions	CP therapy or hyperimmune globulin therapy: CP Details of CP: type of plasma: CP, details of preparation not specified volume: 500 mL number of doses: 1 antibody‐titre: NR pathogen inactivated or not: NR  Treatment details, including time of plasma therapy (e.g. early stage of disease): hospitalised patients with elevated high‐sensitivity troponin or requiring mechanical ventilation For studies including a control group: comparator (type): none Concomitant therapy: NR Treatment cross‐overs: none
Outcomes	Primary study outcome: mortality at day 28 Primary review outcomes All‐cause mortality at hospital discharge: yes (at day 28) Time to death: yes  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): 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 (at day 28) 30‐day and 90‐day mortality: NR (until day 28) Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Additional outcomes Requirement and duration for mechanical ventilation (at day 28)
Starting date	NR
Contact information	Dean J Kereiakes, MD; 513‐585‐1777; lindnermd@thechristhospital.com
Notes	Recruitment status: not yet recruiting  Prospective completion date: August 2020 Sponsor/funding: The Christ Hospital