Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-02 @ 10:03 PM
Study NCT ID:
NCT04547257
Status:
UNKNOWN
Last Update Posted:
2022-01-06
First Post:
2020-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-15', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-09-11', 'lastUpdatePostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'N (%) of patients with treatment emergent adverse events', 'timeFrame': 'Occurrence within the 28 days follow-up period', 'description': 'N (%) of patients with treatment emergent adverse events'}, {'measure': 'Laboratory data', 'timeFrame': 'Daily during ICU stay (up to 28 days)', 'description': 'Laboratory data (blood test, hematology, chemistry, coagulation, and blood gases)'}, {'measure': 'Vital signs score', 'timeFrame': 'Daily during ICU stay (up to 28 days)', 'description': 'Vital signs score'}, {'measure': 'Physical examination score', 'timeFrame': 'Daily during ICU stay (up to 28 days)', 'description': 'Physical examination score'}, {'measure': 'Reduction of viral load', 'timeFrame': 'During treatment (minimum treatment duration is 5 hours, maximum treatment duration is 24 hours)', 'description': 'Reduction of viral load'}], 'primaryOutcomes': [{'measure': 'Change in Organ failure', 'timeFrame': '48 hours after initial treatment', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Change in Organ Failure', 'timeFrame': 'Daily during ICU stay from the start of the initial treatment until day 4', 'description': 'Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range 0 - 20, with higher scores indicating more dysfunction)'}, {'measure': 'All-cause mortality', 'timeFrame': '28 days', 'description': 'All-cause mortality'}, {'measure': 'Organ dysfunction-free days', 'timeFrame': 'Daily during ICU stay (up to 28 days)', 'description': 'Organ dysfunction-free days'}, {'measure': 'Intensive Care Unit (ICU) complications', 'timeFrame': 'Daily during ICU stay (up to 28 days)', 'description': 'Intensive Care Unit (ICU) complications'}, {'measure': 'Ventilator-free days (VFDs)', 'timeFrame': 'Daily during ICU stay (up to 28 days)', 'description': 'Ventilator-free days (VFDs)'}, {'measure': 'Length of stay (LOS) at ICU and hospital ward', 'timeFrame': 'During ICU and hospital ward stay (up to 28 days)', 'description': 'Length of stay (LOS) at ICU and hospital ward'}, {'measure': 'Prognosis Factors', 'timeFrame': 'From baseline up to 48 hours', 'description': 'Prognosis factors (D-Dimer, Troponin T, Ferritin, NTpro-BNP, LDH, IL6, sIL2)'}, {'measure': 'Recurrence of sepsis', 'timeFrame': '7 days', 'description': 'Recurrence of sepsis'}, {'measure': 'Persistence of sepsis', 'timeFrame': '7 days', 'description': 'Persistence of sepsis'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['COVID-19'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19', 'detailedDescription': '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.\n\nThe 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).\n\nSubjects 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects with confirmed SARS-CoV-2 infection\n2. Be ≥ 18 years old and ≤90 years old\n3. Acute respiratory distress syndrome assessed by a modified Sequential Organ Failure Assessment score of at least 2 points\n4. At least one additional organ dysfunction assessed by a modified Sequential Organ Failure Assessment score of at least 1 point\n5. Written or electronic consent of the subjects who are legally competent and have the capacity to give consent\n\nExclusion Criteria:\n\n1. Subject is currently participating in another clinical investigation\n2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period\n3. 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\n4. Have Child-Pugh Class C cirrhosis\n5. Have platelet count \\<30.000/uL\n6. Contraindications for heparin sodium for injection\n7. Subjects demonstrating any contraindication for this treatment as described in the IFU\n8. Subjects with known allergy of polyethylene and copolyester\n9. Subjects with hospital-acquired SARS-CoV-2 infections\n10. Subject is held in an institution by court or official order\n11. Subject is dependent on the sponsor or investigator so that consent can no longer be considered voluntary"}, 'identificationModule': {'nctId': 'NCT04547257', 'acronym': 'CP022', 'briefTitle': 'Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'ExThera Medical Europe BV'}, 'officialTitle': 'Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the Treatment of Patients With COVID-19', 'orgStudyIdInfo': {'id': 'CP022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Extracorporeal therapy with Seraph 100 blood filter', 'interventionNames': ['Device: Seraph 100']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'patients receive antibiotics only as standard of care'}], 'interventions': [{'name': 'Seraph 100', 'type': 'DEVICE', 'description': 'Bloodfiltration with Seraph 100', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63739', 'city': 'Aschaffenburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Büttner, Dr.', 'role': 'CONTACT', 'email': 'stefan.buettner@kgu.de', 'phone': '+49 6021 320'}, {'name': 'Stefan Büttner, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum Aschaffenburg-Alzenau', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '12351', 'city': 'Berlin', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Vivantes Klinikum Neukölln', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '45147', 'city': 'Essen', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ricard Ferrer Roca, Dr.', 'role': 'CONTACT', 'email': 'r.ferrer@vhebron.net', 'phone': '+34 93 489 44 20'}, {'name': 'Ricard Ferrer Roca, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Carla Kikken-Jussen', 'role': 'CONTACT', 'email': 'carla@extheramedical.com', 'phone': '+ 31 43 8200 399'}], 'overallOfficials': [{'name': 'Herwig Gerlach, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vivantes Neukoelln Berlin'}]}, 'ipdSharingStatementModule': {'url': 'http://extheramedical.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'in 9 months', 'ipdSharing': 'YES', 'description': 'The Sponsor will be responsible for determining whether to register the clinical investigation on www.clinicaltrials.gov or any other clinical trials, in accordance with the International Committee of Medical Journal Editors guidelines, or any other applicable guidelines.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ExThera Medical Europe BV', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ExThera Medical Corporation', 'class': 'INDUSTRY'}, {'name': 'Vivantes Clinic Neukölln', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}