AlQahtani 2020.

Study characteristics
Methods	Trial design: RCT, open‐label Type of publication: preprint publication Setting: ICU (hospitalised patients) Recruitment dates: April 2020 to June 2020 Country: Bahrain Language: English Number of centres: 2 Trial registration number: NCT04356534 Date of trial registration: April 22, 2020
Participants	Age: mean age CP arm: 52.6 and control arm: 50.7 Sex: 75% of males in the intervention group and 85% of males in the control group  Ethnicity: NR Number of participants (recruited/allocated/evaluated): 40/40/40 (20 in CP arm and 20 in control arm) Severity of condition according to study definition: severe (requiring oxygen therapy and radiological evidence of pneumonia) Severity of condition according to WHO score: according to WHO 10 point scale: level 5‐7 Comorbidities: diabetes, hypertension, cardiac disease, chronic kidney disease, chronic lung disease, chronic liver disease Inclusion criteria Signed informed consent Aged at least 21 years COVID‐19 diagnosis based on polymerase chain reaction (PCR) testing Hypoxia (oxygen saturation of less than or equal 92% on air, or PO2 < 60 mmHg in arterial blood gas, or arterial partial pressure 90 of oxygen (PaO )/fraction of inspired oxygen (FIO) of 300 or less) and patient requiring oxygen therapy Pneumonia confirmed by chest imaging Exclusion criteria Mild disease not requiring oxygen therapy Normal chest X‐ray and CT scan Requiring ventilatory support (invasive or non‐invasive) History of allergy to plasma, sodium citrate or methylene blue History of autoimmune disease or selective IGA deficiency Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): Donor eligibility criteria Ability to give informed consent Men or nulliparous women (all women had a pregnancy test except for postmenopausal women) PCR COVID‐19 negative from respiratory tract Patients were symptom free Recovered from COVID‐19 and discharged from hospital for more than 2 weeks Patients above the ages of 21 Body weight more than 50 kg Met all donor selection criteria employed for routine plasma collection and plasmapheresis procedures at the collection centre Donor exclusion criteria: NR
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP  Details of CP Type of plasma: NR Volume: 400 mL Number of doses: 200 mL x 2 (2 consecutive days) Type of antibody test and antibody‐titre: NR Pathogen inactivated or not: NR RT‐PCR tested: NR Details of donors Gender: NR HLA and HNA antibody‐negative: NR Severity of disease: NR Timing from recovery from disease: patients who had recovered from COVID‐19 and had been discharged from hospital for more than 2 weeks were approached to be volunteer donors RT‐PCR tested: yes (negative) Treatment details, including time of plasma therapy (e.g. early stage of disease): NR For studies including a control group: comparator (type): randomised to local standard of care, which include antivirals and supportive care or plasma therapy using CP with antibody against SARS‐CoV‐2 plus routine local standard of care Concomitant therapy: standard of care for COVID‐19 disease (standard supportive treatment included control of fever (paracetamol) and possible therapy including antiviral medications, Tocilizumab and antibacterial medication) Duration of follow‐up: NR Treatment cross‐overs: NR Compliance with assigned treatment: good compliance
Outcomes	Primary study outcome: requirement for ventilation (invasive or noninvasive) Primary review outcomes All‐cause mortality at hospital discharge: NR 30‐day mortality: 28‐day mortality reported 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: yes, but transfusion reactions reported Clinical status, assessed by need for respiratory support with standardised scales (e.g. WHO Clinical Progression Scale (WHO 2020e), WHO Ordinal Scale for Clinical Improvement (WHO 2020f)) at up to 7 days, 8 to 15 days, 16 to 30 days: not reported with WHO scale Mortality (time to event): NR 90‐day mortality: NR Time to discharge from hospital: NR Admission on the ICU: NR Length of stay on the ICU: NR Viral clearance, assessed with reverse transcription polymerase chain reaction (RT‐PCR) test for SARS‐CoV‐2 at baseline, up to 3, 7, and 15 days: NR QoL: NR Additional outcomes Reduction in white cell count (time frame: 10 days or until discharge) CRP measurement (time frame: 10 days or until discharge) LDH measurement (time frame: 10 days or until discharge) Procalcitonin measurement (time frame: 10 days or until discharge) D‐Dimer measurement (time frame: 10 days or until discharge) Ferritin measurement (time frame: 10 days or until discharge) Troponin T measurement (time frame: 10 days or until discharge) Brain natriuretic peptide measurement (time frame: 10 days or until discharge)
Notes	Preprint published: November 4, 2020 Sponsor/funding: Royal College of Surgeons in Ireland ‐ Medical University of Bahrain