Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-30 @ 1:57 AM
Study NCT ID:
NCT04358003
Status:
COMPLETED
Last Update Posted:
2022-04-11
First Post:
2020-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Adsorption in Patients With Confirmed COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-07', 'studyFirstSubmitDate': '2020-04-20', 'studyFirstSubmitQcDate': '2020-04-20', 'lastUpdatePostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'Day 28'}], 'secondaryOutcomes': [{'measure': 'Change in Sequential Organ Failure Assessment [SOFA] scores', 'timeFrame': 'Day 28', 'description': 'Scale of 0-24 with a higher number indicating a worse outcome'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'COVID-19', 'Spectra Optia Apheresis System', 'D2000 Cartridge', 'Terumo BCT', 'Marker Therapeutics'], 'conditions': ['Respiratory Failure', 'ARDS']}, 'referencesModule': {'references': [{'pmid': '39267408', 'type': 'DERIVED', 'citation': 'Choi C, De Simone N, Webb CB, Lahsaei P, Yates SG, Raval JS, Harkins MS, Hillebrand DJ, Belli A, Schlapobersky NA, Ipe TS, Banez-Sese GC, Khangoora VS, Nathan SD, Demko TM, Young DC, Caron S, Sarode R. Plasma Adsorption with the MTx.100 Column in Critically Ill COVID-19 Patients: A Prospective Study and Propensity Score Analysis. J Intensive Care Med. 2025 Mar;40(3):314-319. doi: 10.1177/08850666241280031. Epub 2024 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'To characterize the ability of the D2000 Cartridge in combination with the Optia SPD Protocol to reduce the morbidity and mortality associated with SARS-CoV-2 infection in patients admitted to the ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Admitted to ICU\n* Diagnosis of SARS-CoV-2 with any one of the following conditions:\n\n 1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or\n 2. Severe disease, defined as:\n\n 1. dyspnea,\n 2. respiratory frequency ≥ 30/min\n 3. blood oxygen saturation ≤ 93%\n 4. partial pressure of arterial oxygen to fraction of inspired oxygen ratio \\< 300, and/or\n 5. lung infiltrates \\> 50% within 24 to 48 hours; or\n 3. Life-threatening disease, defined as:\n\n 1. respiratory failure,\n 2. septic shock, and/or\n 3. multiple organ dysfunction or failure.\n* Patient fact sheet is provided to the subject.\n* Subject or legal representative is able and willing to give informed consent. If authorized by the IRB, emergent plasma adsorption with the D2000 cartridge may be initiated prior to consent.\n\nExclusion Criteria:\n\n* Treatment limitation or a do not attempt to resuscitate in place\n* Pregnancy\n* Significant or uncontrolled bleeding\n* In the opinion of the investigator, any other condition that precludes plasma adsorption with the D2000'}, 'identificationModule': {'nctId': 'NCT04358003', 'briefTitle': 'Plasma Adsorption in Patients With Confirmed COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Marker Therapeutics AG'}, 'officialTitle': 'Plasma Adsorption in Patients With Confirmed COVID-19 Infection', 'orgStudyIdInfo': {'id': 'MH-007/B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plasma Adsorption Cartridge', 'description': 'Subjects will receive one treatment per day with the D2000 Cartridge for use with the Spectra Optia® Apheresis System (Optia SPD Protocol) for up to 4 hours (treatment cycle) for up to seven (7) days.', 'interventionNames': ['Device: Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)']}], 'interventions': [{'name': 'Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)', 'type': 'DEVICE', 'description': "Subjects will receive one treatment per day with the D2000 Cartridge for up to 4 hours (treatment cycle) for up to seven (7) days. Treatment may extend beyond 7 days, up to 14 days total, if deemed necessary and useful by the principal investigator (PI). Additional cartridges may be used, if needed, to achieve the maximum daily treatment duration of 4 hours. Each day, before initiating the treatment cycle, pre-treatment chemistry and hematology, coagulation status, and disease severity scores (SOFA, APACHE II) will be collected. Then, immediately following the therapy on each treatment day, post-therapy measurements will also be collected.\n\nStudy Exit. Subjects will be exited from the study after the Day 28 follow-up visit which will occur 28 days after Study Day 1. Subjects will be included in the study for a total of 28 days. Subjects may also choose to discontinue at any time or conclude participation at the discretion of the PI or the subject's treating physician.", 'armGroupLabels': ['Plasma Adsorption Cartridge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences (UAMS)', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'UNM Health Science Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Portland Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19611', 'city': 'West Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Reading Hospital', 'geoPoint': {'lat': 40.3337, 'lon': -75.94743}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern/Clements Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77550', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'UTMB', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Medical Campus', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marker Therapeutics AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Terumo BCT', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}