The primary objective of the study is the assessment of impact of immune therapy with COVID-19 convalescent plasma on severity of COVID-19.~The secondary objectives is the Impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection; short-term all-cause mortality; time course of ARDS due to severe COVID-19 and assessment of safety and tolerability of immune therapy with COVID-19 convalescent plasma.~As a primary endpoint/variable we will assess change in SOFA score from Baseline Visit to Day 8.~The study design will be prospective, open-label, randomized, controlled and parallel-grouped.
This phase 2b clinical study will enroll adult subjects of both sexes with ARDS due to COVID-19 necessitating invasive mechanical ventilation.