NCT04348877.

Study name	Plasma rich antibodies from recovered patients from COVID19 (PRA‐001)
Methods	Trial design: single‐arm, interventional Sample size: 20 Setting: critically ill patients Country: Egypt Language: English  Number of centres: 1
Participants	Inclusion criteria 18‐80 years old Laboratory‐confirmed COVID‐19 Severe or immediately life‐threatening COVID‐19 (severe disease is defined as: dyspnoea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, PaO2/FiO2 < 300, and/or lung infiltrates > 50% within 24‐48 h. Life‐threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure) Must provide informed consent by patient or his/her legal guardian or professional legal representative Exclusion criteria Mild or moderate COVID‐19 Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrolment until 30 days post‐treatment in the current study
Interventions	CP therapy or hyperimmune globulin therapy: CP therapy Details of CP: type of plasma: other details not specified volume: 400 mL number of doses: NR 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): none Concomitant therapy: standard of care (antiviral, hydroxychloroquine and antibiotics) (oseltamivir (75 mg/12 h for 5‐10 days) and hydroxychloroquine (400 mg twice in first day, 200 twice for 4‐9 days) ± azithromycin 500 mg daily for 5 days Treatment cross‐overs: none
Outcomes	Primary study outcome: viral COVID‐19 clearance  Primary review outcomes All‐cause mortality at hospital discharge: NR Time to death: NR 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: NR 30‐day and 90‐day mortality: NR Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Additional outcomes Viral COVID‐19 clearance (time frame: 14 days) Radiological improvement (time frame: 14 days) Clinical improvement in form of normal body temperature for 48 h (time frame: 14 days)
Starting date	20 April 2020
Contact information	Hossam Fahmy, Professor of Faculty of Medicine, Ain Shams University
Notes	Recruitment status: not yet recruiting  Prospective completion date: December 2020 Sponsor/funding: Ain Shams University