NCT04375098.

Study name	Efficacy and safety of early anti‐SARS‐COV‐2 convalescent plasma in patients admitted for COVID‐19 infection: a randomized phase II trial
Methods	Trial design: randomized, open‐label, phase II trial Sample size: 30 Setting: inpatient Country: Chile Language: translated to English Number of centres: 1
Participants	Inclusion criteria: Patient > 18 years CALL score ≥ 9 (progression risk score) PCR‐confirmed COVID‐19 infection with ≤ 7 days of symptoms Any symptoms of COVID‐19 infection Admission due to COVID‐19 infection Signed informed consent ECOG before COVID‐19 infection 0‐2 Exclusion criteria: PaFi < 200 or mechanical ventilation indication Clinically relevant co‐infection at admission Pregnancy or lactation IgA deficiency or IgA nephropathy Immunoglobulin or plasma administration in the last 60 days Contraindication to transfusion or previous allergy to blood‐derived products Do‐not‐resuscitate status Patients receiving other investigational drug for COVID‐19 in a clinical trial Any condition, that in opinion of the investigator may increase the risk associated with study participation or interfere with the interpretation of study results
Interventions	Intervention(s): CP Details of CP: Type of plasma: early COVID‐19 CP Volume: 200 mL  Number of doses: 2, day 1 and 2 at admission after confirmation of eligibility Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR Comparator: COVID‐19 CP 200 mL day 1 and 2 only if worsening of respiratory function or persistence of COVID symptoms for > 7 days after enrolment Concomitant therapy: NR Treatment cross‐overs: no
Outcomes	Primary study outcome: Percentage mechanical ventilation, hospitalisation > 14 days or death during hospitalisation (time frame: 1‐year follow‐up) Primary review outcomes reported All‐cause mortality at hospital discharge: 30‐day mortality (percentage) 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): 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: invasive mechanical ventilation during infection;  ECMO duration during infection: yes (median duration of mechanical ventilation (time frame: 1‐year follow‐up) 30‐day and 90‐day mortality: yes (30‐day mortality, (time frame: 1‐year follow‐up), hospital mortality rate (percentage) (time frame: 1‐year follow‐up) Admission on the ICU: NR   Length of stay on the ICU: yes (percentage mechanical ventilation, hospitalisation > 14 days or death during hospitalisation (time frame: 1‐year follow‐up), median length of ICU stay (time frame: 1‐year follow‐up) Time to discharge from hospital: yes (median length of admission (time frame: 1‐year follow‐up) Additional study outcomes Median duration of fever (time frame: 1 year) Readmission rate (percentage) (time frame: 1‐year follow‐up) Median length of viral clearance (time frame: 1‐year follow‐up)
Starting date	4 May 2020
Contact information	Contact: Maria Elvira Balcells, MD +562 23543508 ebalcells@uc.cl
Notes	Recruitment status: recruiting Prospective completion date: December 2020  Sponsor/funding: Pontificia Universidad Catolica de Chile, Fundacion Arturo Lopez Perez,  Principal Investigator: Maria Elvira Balcells, MD ebalcells@uc.cl