NCT04347681.

Study name	A national collaborative multicenter phase II study for potential efficacy of convalescent plasma to treat severe COVID‐19 and patients at high risk of developing severe COVID‐19
Methods	Trial design: non‐randomised, parallel assignment Sample size: 40 (all receiving intervention)  Setting: hospital Country: Saudi Arabia Language: English  Number of centres: 10
Participants	Inclusion criteria  ≥ 18 years COVID 19 confirmed as per case definition of CDC or Ministry of Health/Waqayah Must have been requiring ICU care or severe or immediately life‐threatening care: 1. patient requiring ICU admission; 2. severe disease, defined as: dyspnoea respiratory frequency ≥ 30/min blood oxygen saturation ≤ 93% PaO2/FiO2 < 300, and/or lung infiltrates > 50% within 24‐48 h 3. Life‐threatening disease is defined as: respiratory failure septic shock, and/or multiple organ dysfunction or failure Exclusion criteria Negative or non‐conclusive test COVID‐19 rRT‐PCR test for SARS‐CoV‐2 Mild symptoms Hospitalisation not requiring ICU admission
Interventions	CP therapy or hyperimmune globulin therapy: CP therapy Details of CP: type of plasma: NR volume: 10‐15 mL/kg body weight of recipient number of doses: 1‐5 (up to 5 times daily) 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: NR Treatment cross‐overs: none (single‐arm)
Outcomes	Primary study outcome: ICU length of stay, safety and serious adverse reactions Primary review outcomes All‐cause mortality at hospital discharge: yes (up to 12 weeks) Time to death: yes (up to 12 weeks)  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): yes Number of participants with SAEs: yes 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 Days to clinical recovery, defined as number of days to symptoms resolution and COVID 19 negative PCR (by nasopharyngeal swab) (time frame: time from signing consent to recovery, up to 12 weeks)
Starting date	12 April 2020
Contact information	Hani AL‐Hashmi, MD; 00966564773377; hanih.hashmi@kfsh.med.sa Mahammad Awadallah, MSc; 00966545032312; mahammad.awadalla@kfsh.med.sa
Notes	Recruitment status: recruiting in 1 site  Prospective completion date: 11 April 2021 Sponsor/funding: King Fahad Specialist Hospital Dammam