Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19

Full Title: A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19. Short Title: PROTECT-Patient study Aim: Assess the safety and efficacy of COVID-19 convalescent plasma (CCP) as a therapeutic treatment for hospitalised patients with moderate to severe COVID-19 Study Design: Randomised, double-blinded, placebo-controlled, phase III clinical trial Intervention: Randomised 1:1 to either CCP plus standard of care (SOC) or to SOC plus placebo (200 mL normal saline) Active Agent: A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines. Placebo: A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines Sample Size: 600 Study Population: Consenting adult inpatients with moderate to severe COVID-19, not requiring invasive ventilation, who are admitted to a participating public or private sector hospital and who are not enrolled in another COVID-19 treatment trial. Settings: Participating public and private sector hospitals in South Africa