This phase 2b clinical study will enroll adult subjects of both sexes with ARDS due to COVID-19 necessitating invasive mechanical ventilation.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Infusion of a total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 in Addition to standard treatment.
University Hospital Erlangen
Erlangen, Germany
RECRUITINGChange in SOFA score from Baseline Visit
Change in Sequential organ failure assessment (SOFA) score predicts Predicts ICU mortality based on lab results and clinical data. SOFA includes PaO2, the Glasgow Coma Scale, Mean arterial pressure OR Administration of sedatives, Bilirubin(mg/dl), Creatinine (mg/dl) and platelets. All values are rated with a value of 1 to 4 (worst condition) and are added up gradually to a final score. The lower the SOFA score, the better is the prognosis (Maximum value 24)
Time frame: [Day 1, Visit 2] to Day 8 [Visit 9]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection
Mean number of days without invasive mechanical ventilation during the period from Baseline Visit \[Day 1, Visit 2\] until and including Day 8 \[Visit 9\], Day 15 \[Visit 13\], and Day 29 \[Visit 15\], per treatment group and per subject. Time from Baseline Visit \[Day 1, Visit 2\] to extubation.
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on short-term all-cause mortality
Assessment of mortality during defined time-frame
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen supply in patients with ARDS due to severe COVID-19
Number of subjects without supplemental oxygen on Day 8 \[Visit 9\], on Day 15 \[Visit 13\], and on Day 29 \[Visit 15\].
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on oxygen demand in patients with ARDS due to severe COVID-19
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Proportion of subjects without supplemental oxygen on Day 8 \[Visit 9\], on Day 15 \[Visit 13\], and on Day 29 \[Visit 15\].
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of Oxygen supply in patients with ARDS due to severe COVID-19
Mean number of days without supplemental oxygen during the period from Baseline Visit \[Day 1, Visit 2\] until and including Day 8 \[Visit 9\], Day 15 \[Visit 13\], and Day 29 \[Visit 15\], per treatment group and per subject.
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on PEEP in patients with ARDS due to severe COVID-19
Mean relative change of PEEP from Baseline Visit \[Day 1, Visit 2\] to all subsequent visits until and including Day 29 \[Visit 15\] or until stop of invasive mechanical ventilation, whichever comes first.
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on FiO2 in patients with ARDS due to severe COVID-19
Mean relative change of FiO2 from Baseline Visit \[Day 1, Visit 2\] to all subsequent visits until and including Day 29 \[Visit 15\] or until stop of invasive mechanical ventilation, whichever comes first.
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on driving pressure in patients with ARDS due to severe COVID-19
Mean relative change of driving pressure from Baseline Visit \[Day 1, Visit 2\] to all subsequent visits until and including Day 29 \[Visit 15\] or until stop of invasive mechanical ventilation, whichever comes first.
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]
Assessment of impact of immune therapy with COVID-19 convalescent plasma on Duration of invasive mechanical Ventilation in patients with ARDS due to severe COVID-19
Time from Baseline Visit \[Day 1, Visit 2\] to stop of invasive mechanical ventilation.
Time frame: Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15]