COVID-19
Conditions
Keywords
COVID-19
Brief summary
Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19
Detailed description
This is a prospective, open-label, randomized, controlled clinical investigation designed to evaluate the safety and effectiveness of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the treatment of patients with confirmed SARS-CoV-2 infection. The clinical investigation will be conducted at 3 centers in Germany and at 2 centers in Spain. Subjects will be randomized to the treatment group (Seraph 100 + standard of care) versus control group (standard of care only). Subjects will be followed for 28 days. For viral quantification, study-related serum samples are done immediately before the initial treatment with Seraph 100 starts in the treatment group or immediately after randomization into the control group. Additionally, serum sampling at timepoint 12 hours is applicable for both treatment and control group.
Interventions
DEVICESeraph 100
Bloodfiltration with Seraph 100
Sponsors
ExThera Medical Corporation
Vivantes Clinic Neukölln
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The primary objective is to demonstrate the safety and effectiveness of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the clinical improvement of SARS-CoV-2 infected patients, measured by the reduction of established and suspected prognostic parameters.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects with confirmed SARS-CoV-2 infection 2. Be ≥ 18 years old and ≤90 years old 3. Acute respiratory distress syndrome assessed by a modified Sequential Organ Failure Assessment score of at least 2 points 4. At least one additional organ dysfunction assessed by a modified Sequential Organ Failure Assessment score of at least 1 point 5. Written or electronic consent of the subjects who are legally competent and have the capacity to give consent
Exclusion criteria
1. Subject is currently participating in another clinical investigation 2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period 3. Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results 4. Have Child-Pugh Class C cirrhosis 5. Have platelet count \<30.000/uL 6. Contraindications for heparin sodium for injection 7. Subjects demonstrating any contraindication for this treatment as described in the IFU 8. Subjects with known allergy of polyethylene and copolyester 9. Subjects with hospital-acquired SARS-CoV-2 infections 10. Subject is held in an institution by court or official order 11. Subject is dependent on the sponsor or investigator so that consent can no longer be considered voluntary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Organ failure | 48 hours after initial treatment | Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Organ Failure | Daily during ICU stay from the start of the initial treatment until day 4 | Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range 0 - 20, with higher scores indicating more dysfunction) |
| All-cause mortality | 28 days | All-cause mortality |
| Organ dysfunction-free days | Daily during ICU stay (up to 28 days) | Organ dysfunction-free days |
| Intensive Care Unit (ICU) complications | Daily during ICU stay (up to 28 days) | Intensive Care Unit (ICU) complications |
| Ventilator-free days (VFDs) | Daily during ICU stay (up to 28 days) | Ventilator-free days (VFDs) |
| Length of stay (LOS) at ICU and hospital ward | During ICU and hospital ward stay (up to 28 days) | Length of stay (LOS) at ICU and hospital ward |
| Prognosis Factors | From baseline up to 48 hours | Prognosis factors (D-Dimer, Troponin T, Ferritin, NTpro-BNP, LDH, IL6, sIL2) |
| Recurrence of sepsis | 7 days | Recurrence of sepsis |
| Persistence of sepsis | 7 days | Persistence of sepsis |
Countries
Germany, Spain
Contacts
PRINCIPAL_INVESTIGATORHerwig Gerlach, Prof.
Vivantes Neukoelln Berlin
Outcome results
None listed