NCT04389710.

Study name	Convalescent plasma for the treatment of patients with COVID‐19
Methods	Trial design: single‐arm intervention  Sample size: 100 Setting: inpatient Country: USA Language: English Number of centres: 1
Participants	Inclusion criteria Age ≥ 18 years Laboratory‐confirmed diagnosis of SARS‐CoV‐2 Admitted to an acute care facility for the treatment of COVID‐19 complications Informed consent provided by patient or LAR Severe or life‐threatening COVID‐19, or judged by the treating provider to be at high risk of progression to severe or life‐threatening disease Severe disease defined as any of the following Dyspnoea Respiratory rate > 30/min Oxygen saturation < 94% Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 Lung infiltrates > 50% within 24‐48 h Life‐threatening disease defined as any of the following Respiratory failure Septic shock Multiple organ dysfunction or failure Informed consent provided by patient or healthcare proxy Exclusion criteria Receipt of pooled immunoglobulin in past 30 days Contraindication to transfusion or history of prior reactions to transfusion blood products
Interventions	Intervention(s): CP therapy Details of CP: Type of plasma: ABO‐compatible Volume: 200‐600 mL Number of doses: 1‐2 Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): inpatient with severe or life‐threatening disease Comparator: nil Concomitant therapy: NR Treatment cross‐overs: no
Outcomes	Primary study outcome: number of participants who receive COVID‐19 CP transfusions in acute care facilities infected with SARS‐CoV‐2 (time frame: 1 year) Primary review outcomes reported All‐cause mortality at hospital discharge: yes Time to death: yes 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: invasive mechanical ventilation during infection; ECMO duration during infection 30‐day and 90‐day mortality: yes  Admission on the ICU: yes Length of stay on the ICU: yes  Time to discharge from hospital: yes  QoL: NR Additional study outcomes Changes in complete blood count Abnormal changes in basic metabolic panel (BMP) measures Changes in CRP,  d‐dimer, fibrinogen, prothrombin time (PT), partial thromboplastin time (PTT) in participants after receiving CP (time frame: 0 and 7 days)
Starting date	15 April 2020
Contact information	Michael Baram, MD215‐955‐5161 Michael.Baram@jefferson.edu Anna Marie Chang, MD215‐605‐5897 AnnaMarie.Chang@jefferson.edu
Notes	Recruitment status: recruiting Prospective completion date: 14 April 2021 Sponsor/funding: Thomas Jefferson University