NCT04342182.

Study name	Convalescent plasma therapy from recovered COVID‐19 patients as therapy for hospitalized patients with COVID‐19 (CONCOVID Study) (ConCoVid‐19)
Methods	Trial design: open‐label, RCT Sample size: 426 Setting: hospitalised patients  Country: Netherlands  Language: English Number of centres: 2
Participants	Inclusion criteria  Patients with PCR‐confirmed COVID disease Written informed consent by patient or legal patient representative Age > 18 Exclusion criteria  Patient in which a 'no ICU admission' or 'no invasive ventilation' restriction was implemented at the time of screening for the study Donor eligibility criteria Donors with a history of COVID infection that was documented by PCR Known ABO‐Resus(D) blood group Negative screening for irregular antibodies Asymptomatic for at least 24 h Written informed consent regarding the plasmapheresis procedure Donor exclusion criteria Donors excluded if age < 18 years and > 66 years Weight < 45 kg Medical history of heart failure History of transfusion with red blood cells, platelets or plasma
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP  Details of CP: type of plasma: Infusion of plasma retrieved from donors with a history of PCR‐proven symptomatic COVID volume: 300 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): NR For studies including a control group: comparator (type): standard of care (supportive care, oxygen, antibiotics) Concomitant therapy: standard of care Treatment cross‐overs: none
Outcomes	Primary study outcome: overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever comes first Primary review outcomes All‐cause mortality at hospital discharge: yes (overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever comes first) 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: yes 30‐day and 90‐day mortality: yes (up to 30 days post‐discharge) Admission on the ICU: yes Length of stay on the ICU: yes Time to discharge from hospital: yes QoL: NR Additional outcomes Impact of plasma therapy on the decrease in SARS‐CoV‐2 shedding from airways (time frame: until hospital discharge, estimated average 2 weeks)
Starting date	8 April 2020
Contact information	Bart Rijnders, MD, PhD+31107033510; b.rijnders@erasmusmc.nl
Notes	Recruitment status: recruiting (1 site only, 2nd site not yet recruiting) Prospective completion date: 1 July 2020 Sponsor/funding: Erasmus Medical Center