ARDS due to COVID-19 necessitating invasive mechanical ventilation MedDRA version: 23.0 Level: LLT Classification code 10084270 Term: SARS-CoV-2 acute respiratory disease System Organ Class: 100000004862 MedDRA version: 21.1 Level: LLT Classification code 10003083 Term: ARDS System Organ Class: 100000004855
Conditions
Interventions
Product Name: COVID-19 Immunplasma FAU
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: COVID-19 convalescent plasma
Other descriptive name: SARS-CoV-2 convalescent plasma
Concentration
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subject aged =18 years. 2. Estimated BMI =19kg/m² to =40kg/m². 3. Florid SARS-CoV-2 infection confirmed by RT-PCR in tracheo-bronchial secretion sample or pharyngeal swab sample. 4. ARDS with Horovitz index =65 years) yes F.1.3.1 Number of subjects for this age range 29
Exclusion criteria
Exclusion criteria: 1. Adverse reaction to plasma proteins in medical history. 2. Interval >72h since endotracheal intubation. 3. Current or imminent necessity of ECMO treatment. 4. Pre-existing COPD GOLD stage 4. 5. Chronic congestive heart failure NYHA =3. 6. Pre-existing left ventricular ejection fraction 5x ULN and either ALT or AST >10x ULN. 9. Known congenital, selective severe deficiency of immunoglobulin A (IgA not detectable or close to detection Limit in contrast to other Ig). 10. Cardiovascular resuscitation in the 14 days prior to Screening Visit [V1]. 11. Organ or bone marrow transplant in the three months prior to Screening Visit [V1]. 12. Pregnancy. 13. Breastfeeding woman. 14. ? Previous exposure to COVID-19 convalescent plasma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of impact of immune therapy with COVID-19 convalescent plasma on severity of COVID-19;Secondary Objective: Assessment of 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. Assessment of safety and tolerability of immune therapy with COVID-19 convalescent plasma. ;Primary end point(s): Change in SOFA score from Baseline Visit [Day 1, Visit 2] to Day 8 [Visit 9];Timepoint(s) of evaluation of this end point: Day 8 (Visit 9) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Baseline until EOS (day 61 -3/+21 days);Secondary end point(s): - SOFA score: Mean change from Baseline Visit [Day 1, Visit 2] to all subsequent visits until and including Day 29 [Visit 15] or until extubation, whichever comes first - Rescue therapy: Number and proportion of subjects without rescue therapy until and including Day 8 [Visit 9] - ECMO: Mean number of days without ECMO 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 - Invasive mechanical ventilation parameters and endotracheal Intubation: 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 - Survival: Number and proportion of subjects having died until and including Day 29 [Visit 15] and End of Study Visit [Day 61±3 days, Visit 16] - Safety: ? Cumulated number and proportion of subjects with AE, AR, SAE, SAR, and SUSAR from Baseline Visit [Day 1, Visit 2] until and including Day 11 [Visit 12] | — |
Countries
Germany
Contacts
Public ContactTransfusionsmedizinische Abteilung
Universitätsklinikum Erlangen
Outcome results
None listed