NCT04354831.

Study name	An open label, phase 2 study evaluating the efficacy and safety of high‐titre anti‐SARS‐CoV‐2 plasma in hospitalized patients with COVID‐19 infection
Methods	Trial design: non‐randomised Sample size: 106 Setting: hospital Country: USA Language: English Number of centres: NR
Participants	Inclusion criteria  Age ≥ 18 years Hospitalised as an inpatient with positive COVID‐19 test by PCR Presence of respiratory symptoms with any of severe features as below: respiratory rate ≥ 24/min oxygen support > 3 L/min by nasal cannula new onset or worsening of respiratory symptoms with radiologic confirmation of bilateral ground glass opacities that cannot be attributed to another cause Patient/HCPOA must agree to storage of blood specimens for future testing Patient/HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, HCPOA should be defined and able to consent for the patient Allowed to receive all standard of care. Co‐enrolment in other clinical trials is permitted Exclusion criteria Women of childbearing potential with positive pregnancy test (mandatory) Breastfeeding Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies Mechanical ventilation for > 14 days Days from symptom onset > 21 days Expected survival < 72 h Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI Patients who were previously admitted to ICU cannot be enrolled in the non‐ICU cohort. These patients could need ICU‐level care subsequently and at that time point could be considered for ICU cohort.
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP therapy Details of CP: type of plasma: SARS‐CoV‐2 CP volume: 1‐2 units; ~200‐400 mL maximum dose as 7 mL/kg adjusted ideal body weight  number of doses: study drug will be administered as a single IV infusion antibody‐titre: NR pathogen inactivated or not: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR For studies including a control group: comparator (type): NR Concomitant therapy: NR Treatment cross‐overs: not applicable
Outcomes	Primary study outcome: overall mortality within 60 days Primary review outcomes All‐cause mortality at hospital discharge: overall mortality within 60 days 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): 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: NR 30‐day and 90‐day mortality: NR Admission on the ICU: yes Length of stay on the ICU: yes Time to discharge from hospital: NR QoL: NR Additional outcomes: NR
Starting date	1 May 2020
Contact information	Mary Beth Graham, MD, Medical College of Wisconsin, USA mailto:mbgraham%40mcw.edu?subject=NCT04354831, PRO00037712, A Study Evaluating the Efficacy and Safety of High‐Titer Anti‐SARS‐CoV‐2 Plasma in Hospitalized Patients With COVID‐19 Infection
Notes	Recruitment status: not yet recruiting Prospective completion date: 1 May 2023 Sponsor/funding: Medical College of Wisconsin, USA