NCT04346589.

Study name	A pilot study to explore the efficacy and safety of rescue therapy with antibodies from convalescent patients obtained with double ‐filtration plasmapheresis (DFPP) and infused in critically ill ventilated patients with coronavirus disease 2019 (COVID‐19)
Methods	Trial design: interventional (single‐arm)   Sample size: 10 Setting: critically ill patients  Country: Italy Language: English Number of centres: 5
Participants	Inclusion criteria  > 18‐years, men and women COVID‐19 pneumonia diagnosed by standard criteria Need of ventilator support Informed consent for participation in the study (critically ill patients will be unable to provide consent. Consent will be oral if a written consent will be impossible. If the patient is incapable of giving an informed consent and an authorised representative is not available without a delay that would, in the opinion of the Investigator, compromise the potential life‐saving effect of the treatment this can be administered without consent. Consent to remain in the research should be sought as soon as the conditions of the patient will allow it). < 48 h of mechanical ventilation Exclusion criteria  Patient being treated with other anti‐COVID‐19 experimental treatments
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP  Details of CP: type of plasma: anti‐coronavirus antibodies obtained with double‐filtration plasmapheresis (DFPP) from convalescent patients volume: convalescent antibodies will be obtained with one DFPP procedure from consenting donors  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): critically ill mechanically ventilated patients (< 48 h mechanical ventilation) For studies including a control group: comparator (type): none (single‐arm) Concomitant therapy: NR Treatment cross‐overs: none (single‐arm)
Outcomes	Primary study outcome: number of mechanical ventilation days Primary review outcomes All‐cause mortality at hospital discharge: yes (up to 6 months)  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 Admission on the ICU: yes Length of stay on the ICU: yes Time to discharge from hospital: NR QoL: NR Additional outcomes Number of mechanical ventilation days Shift to CPAP ventilation
Starting date	April 2020
Contact information	Piero Luigi Ruggenenti, MD; 0039 035 267 ext 3814; pruggenenti@asst-pg23.it
Notes	Recruitment status: not yet recruiting Prospective completion date: July 2020 Sponsor/funding: A.O. Ospedale Papa Giovanni XXIII, Aferetica ‐ Italy (BO)