COVID-19 Clinical Trial
— CP022Official title:
Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the Treatment of Patients With COVID-19
NCT number | NCT04547257 |
Other study ID # | CP022 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 4, 2021 |
Est. completion date | December 31, 2022 |
Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19
Status | Recruiting |
Enrollment | 42 |
Est. completion date | December 31, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Aschaffenburg-Alzenau | Aschaffenburg | |
Germany | Vivantes Klinikum Neukölln | Berlin | |
Germany | Universitätsklinikum Essen | Essen | |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
Spain | Hospital Clinico San Carlos | Madrid |
Lead Sponsor | Collaborator |
---|---|
ExThera Medical Europe BV | ExThera Medical Corporation, Vivantes Klinikum Neukölln |
Germany, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | N (%) of patients with treatment emergent adverse events | N (%) of patients with treatment emergent adverse events | Occurrence within the 28 days follow-up period | |
Other | Laboratory data | Laboratory data (blood test, hematology, chemistry, coagulation, and blood gases) | Daily during ICU stay (up to 28 days) | |
Other | Vital signs score | Vital signs score | Daily during ICU stay (up to 28 days) | |
Other | Physical examination score | Physical examination score | Daily during ICU stay (up to 28 days) | |
Other | Reduction of viral load | Reduction of viral load | During treatment (minimum treatment duration is 5 hours, maximum treatment duration is 24 hours) | |
Primary | Change in Organ failure | 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 | 48 hours after initial treatment | |
Secondary | Change in Organ Failure | Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range 0 - 20, with higher scores indicating more dysfunction) | Daily during ICU stay from the start of the initial treatment until day 4 | |
Secondary | All-cause mortality | All-cause mortality | 28 days | |
Secondary | Organ dysfunction-free days | Organ dysfunction-free days | Daily during ICU stay (up to 28 days) | |
Secondary | Intensive Care Unit (ICU) complications | Intensive Care Unit (ICU) complications | Daily during ICU stay (up to 28 days) | |
Secondary | Ventilator-free days (VFDs) | Ventilator-free days (VFDs) | Daily during ICU stay (up to 28 days) | |
Secondary | Length of stay (LOS) at ICU and hospital ward | Length of stay (LOS) at ICU and hospital ward | During ICU and hospital ward stay (up to 28 days) | |
Secondary | Prognosis Factors | Prognosis factors (D-Dimer, Troponin T, Ferritin, NTpro-BNP, LDH, IL6, sIL2) | From baseline up to 48 hours | |
Secondary | Recurrence of sepsis | Recurrence of sepsis | 7 days | |
Secondary | Persistence of sepsis | Persistence of sepsis | 7 days |
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