Hamdy Salman 2020.

Study characteristics
Methods	Trial design: RCT, double‐blinded Type of publication: journal publication Setting: hospital (inpatient and ICU) Recruitment dates: June 2020 to August 2020 Country: Egypt Language: English Number of centres: 1 Trial registration number: NCT04530370 Date of trial registration: August 28, 2020
Participants	Age: median (IQR): 57.0 (50.0–66.0) Sex: 70% of males in the intervention and control group together Ethnicity: NR Number of participants (recruited/allocated/evaluated): 45/30/30 Severity of condition according to study definition: patients with COVID‐19 severe conditions (no clear definition reported) Severity of condition according to WHO score: not clear Comorbidities: diabetes and respiratory disease Inclusion criteria Hospitalised patients ≥ 18 years Confirmed positive nasopharyngeal/oropharyngeal COVID‐19 swab With two or more of a four‐category illness‐severity scale: respiratory frequency ≥ 24/min blood oxygen saturation ≤ 93% on room air partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 mmHg pulmonary infiltrates occupying more than 50% of both lungs Exclusion criteria Any patient with prior allergic history to plasma or plasma products or septic shock or multiple organ failure was excluded from the study. Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): all patients received steroid and oxygen supportive therapy as required. Donor eligibility criteria A history of COVID‐19 infection confirmed by positive nasopharyngeal swab/oropharyngeal swab test Complete recovery of symptoms for at least 2 weeks prior to donation, documented with negative nasopharyngeal/oropharyngeal swab All blood products followed standard blood handling and processing procedures and regulations Donor exclusion criteria: NR
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP Details of CP Type of plasma: NR Volume: 250 mL Number of doses: 1 Type of antibody test and antibody‐titre: neutralising antibody, Cusabio, ELISA Kit Catalog Number. CSBEL23253HU for the qualitative determination of SARS‐CoV‐2 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: complete recovery of symptoms for at least 2 weeks prior to donation RT‐PCR tested: yes Treatment details, including time of plasma therapy (e.g. early stage of disease): NR For studies including a control group Comparator (type): standard care Concomitant therapy: available standard therapy, when appropriate, included: supplemental oxygen noninvasive and invasive ventilation antibiotic medication inotrope drugs renal‐replacement therapy anticoagulants glucocorticoids intravenous fluids interferon extracorporeal membrane oxygenation (ECMO) Duration of follow‐up: 5 days Treatment cross‐overs: NA Compliance with assigned treatment: yes
Outcomes	Primary study outcome 50% Improvement of severity of illness was defined as achieving a minimum of two‐point reduction on the four‐category illness severity scale: respiratory frequency ≥ 24/min blood oxygen saturation ≤ 93% on room air partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 mmHg; pulmonary infiltrates occupying more than 50% of both lungs, during 5 days study period Primary review outcomes All‐cause mortality at hospital discharge: NR 30‐day mortality: 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): transfusion‐related complications Number of participants with SAEs: NR 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: NR 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: yes at day 3 QoL: NR Additional review outcomes Laboratory biomarkers of severe COVID‐19 infections were assessed, included serum levels of: ferritin, D‐dimer, troponin, lactic dehydrogenase creatine phosphokinase, lymphocytic count, and C‐reactive protein.
Notes	Journal published: 3 November 2020 Sponsor/funding: South Valley University