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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date April 2021
Source ExThera Medical Europe BV
Contact Carla Kikken-Jussen
Phone + 31 43 8200 399
Email carla@extheramedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Seraph 100
Bloodfiltration with Seraph 100

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
ExThera Medical Europe BV ExThera Medical Corporation, Vivantes Klinikum Neukölln

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

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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