NCT04397757.

Study name	An an open‐label, controlled, phase 1, safety and exploratory efficacy study of convalescent plasma for severely ill, hospitalized participants with COVID‐19 pneumonia caused by SARS‐CoV‐2
Methods	Trial design: open‐label RCT Sample size: 80 Setting: inpatient Country: USA Language: English Number of centres: 1
Participants	Inclusion criteria Adult ≥ 18 years of age Laboratory‐confirmed SARS‐CoV‐2 infection as determined by PCR or other authorised or approved assay in any specimen collected within 72 h prior to enrolment Note ‐ An exception must be requested to the Sponsor if ≥ 72 h since positive test Hospitalised in participating facility Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest X‐ray or CT scan) Abnormal respiratory status that is judged worse than baseline by the investigator and as documented at any point within 24 h prior to randomisation, consistent with ordinal scale levels 5, 6 or 7, specifically defined as: Room air saturation of oxygen (SaO2) < 93%, OR Requiring supplemental oxygen, OR Tachypnea with respiratory rate ≥ 30 Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements Exclusion criteria Contraindication to transfusion (e.g. severe volume overload, history of severe allergic reaction to blood products), as judged by the investigator Clinical suspicion that the aetiology of acute illness (acute decompensation) is primarily due to a condition other than COVID‐19 Receipt of other investigational therapy as a part of another clinical trial. Note: investigational therapies used as part of clinical care, (e.g., remdesivir, hydroxychloroquine) are permissible.
Interventions	Intervention(s): CP therapy Details of CP: Type of plasma: NR Volume: NR Number of doses: 2 Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): hospitalised patients (severe) Comparator: standard care Concomitant therapy: NR Treatment cross‐overs: not applicable
Outcomes	Primary study outcome: Participants with SAEs (at day 29) Comparison of clinical severity score between patients on the experimental versus control arms (at day 29) Primary review outcomes reported All‐cause mortality at hospital discharge: 29‐day mortality 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: yes (28‐day mortality) Admission on the ICU: yes Length of stay on the ICU: NR Time to discharge from hospital: yes (up to 29 days) QoL: NR Additional study outcomes: time to recovery (defined as clinical severity score 1‐3), clinical status assessment using the National Early Warning Score (NEWS) of CP administration, WBC, hemoglobin, platelet counts, creatinine, glucose, bilirubin, ALT, AST, PT
Starting date	13 March 2020
Contact information	Katharine J. Bar, MD       (215) 349‐8092  BarK@pennmedicine.upenn.edu Julie Starr            215‐349‐8527    jstarr@pennmedicine.upenn.edu
Notes	Recruitment status: recruiting Prospective completion date: 13 November 2020 Sponsor/funding: University of Pennsylvania