Patients with SARS-CoV-2 infection and: 1. age = 18 years and = 75 years 2. SARS-CoV-2 infection confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap) 3. severe disease defined by at least one of the following: a. respiratory rate = 30 breaths / minute under ambient air b. requirement of any type of ventilation support c. needs ICU treatment MedDRA version: 20.1 Level: LLT Classification code 10047475 Term: Viral pneumonia, unspecified System Organ Class: 10000
Conditions
Interventions
Trade Name: Fresh frozen plasma (FFP) with marketing authorisation in Germany issued by PEI
Product Name: For example "Gefrorenes Frischplasma / Apherese DRK Blutspendedienst"
Pharmaceutical Form: So
Sponsors
DRK-Bluspendedienst Baden-Württemberg - Hessen gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with SARS-CoV-2 infection and: 1. age = 18 years and = 75 years 2. SARS-CoV-2 infection confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap) 3. severe disease defined by at least one of the following: a. respiratory rate = 30 breaths / minute under ambient air b. requirement of any type of ventilation support c. needs ICU Treatment 4. Written informed consent by patient or legally authorized representative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 88 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: 1. Accompanying diseases other than COVID-19 with an expected survival time of less than 12 months 2. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatment 3. Interval > 72 hours since start of ventilation support 4. Not considered eligible for extracorporeal oxygenation support (even in case of severe ARDS according to Berlin classification with Horovitz-Index 5 x ULN and elevation of ALT or AST (> 10 x ULN) 11. Any history of adverse reactions to plasma proteins 12. Known deficiency of immunoglobulin A 13. Pregnancy 14. Breastfeeding women 15. Volume overload until sufficiently treated 16. Pulmonary edema 17. Participation in another clinical trial for treatment of COVID-19
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To improve survival AND remove criteria of severe COVID-19 (CoV-2 infection) within 21 days after randomization;Secondary Objective: - Time to clinical improvement on WHO R&D Blueprint seven-category ordinal scale by 2 - Adverse events - Case fatality rate on days 21, 35 and 60 - Length of hospital stay - Length of ICU stay - Duration of ventilation Support / ECMO - Time until negative SARS-CoV-2 PCR - Predictive value of comorbidities and inflammation markers - Feasibility of collection of plasma units - Kinetics of anti-SARS-CoV-2 antibodies in plasma of patients = plasma donors who recovered from a SARS-CoV-2 infection - Titer of anti-SARS-CoV-2 in transfused plasma units - Impact of donor characteristics on anti-SARS-CoV-2 humoral response - Course of anti-SARS-CoV-2 titer in patients - Effect of timing of plasma transfusions on outcome Objectives relating to the extended observational phase can be found within the most current protocol version.;Primary end point(s): Composite endpoint of: - Survival AND - no longer fulfilling criteria of severe COVID-19 within 21 days after randomization All criteria must be met in order to fulfill the primary endpoint. ;Timepoint(s) of evaluation of this end point: Treatment group: Day 21 Control group: Days 14 and 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to clinical improvement on WHO R&D Blueprint seven-category ordinal scale by 2 - Adverse events - Case fatality rate on days 21, 35 and 60 - Length of hospital stay - Length of ICU stay - Duration of ventilation Support / ECMO - Time until negative SARS-CoV-2 PCR - Predictive value of comorbidities and inflammation markers - Feasibility of collection of plasma units - Kinetics of anti-SARS-CoV-2 antibodies in plasma of patients = plasma donors who recovered from a SARS-CoV-2 infection - Titer of anti-SARS-CoV-2 in transfused plasma units - Impact of donor characteristics on anti-SARS-CoV-2 humoral response - Course of anti-SARS-CoV-2 titer in patients - Effect of timing of plasma transfusions on outcome Endpoints relating to the extended observation phase: - Long term survival* up to 15 months after randomisation (patients in CCP group* compared to control group) or first plasma donation (CCP donors). - Frequency, severity and duration of long COVID-19* up to 540 days after randomisation (patients in CCP group* compared to control group) or first plasma donation (CCP donors) - Resolution of pneumonia and functional recovery* in patients (CCP group compared to control group and donors) - Fatigue* (in patients CCP group compared to control group and donors) - QoL* (in patients: CCP group compared to control group and donors) - Utilization of health care resources* (in patients: CCP group compared to control group and donors) - Anti-SARS-CoV-2 immunity and inflammation* (in patients: CCP group compared to control group and donors). - Effect of SARS-CoV-2 vaccination* in control group, CCP group and CCP donors For the endpoints mentioned above (*) also a subgroup analysis by the cumulative amount of transfused neutralizing units in the CCP is planned. ;Timepoint(s) of evaluation of this end point: Treatment group: Prior to transfusion of convalescent plasma on days 1, 3 and 5 and one day after infusion (days 2, 4 and 6) and eve | — |
Countries
Germany
Contacts
Public ContactSixten Körper
IKT Ulm
Outcome results
None listed