Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-28 @ 8:03 PM
Study NCT ID:
NCT04389450
Status:
TERMINATED
Last Update Posted:
2024-08-30
First Post:
2020-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel']}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'whyStopped': "The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2020-05-14', 'studyFirstSubmitQcDate': '2020-05-14', 'lastUpdatePostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of ventilator free days', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '28 days'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID', 'ARDS']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.pluristem.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.\n* Male or non-pregnant female adult 40-80 years of age at time of enrollment.\n* Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization.\n* Meets definition of ARDS according to Berlin criteria.\n\nKey Exclusion Criteria:\n\n* Body weight under 55 kg (121 lbs)\n* Serum creatinine level of over 1.5 mg/dL at time of randomization.\n* Total Bilirubin ≥2 mg/dL at time of randomization.\n* Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.\n* Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization.\n* Chronic Obstructive Pulmonary disease GOLD stage above II.'}, 'identificationModule': {'nctId': 'NCT04389450', 'briefTitle': 'Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pluristem Ltd.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of Severe COVID-19', 'orgStudyIdInfo': {'id': 'PLX-COV-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PLX-PAD interval high dose', 'description': 'PLX-PAD will be administered via 15 IM injections (1 mL each). Each subject will be treated twice, with an interval of 1 week between treatments.', 'interventionNames': ['Biological: PLX-PAD']}, {'type': 'EXPERIMENTAL', 'label': 'PLX-PAD low dose', 'description': 'PLX-PAD 300, single administration, second administration of placebo after 1 week.', 'interventionNames': ['Biological: PLX-PAD']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group A', 'description': 'Placebo, two administrations, 1 week apart', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PLX-PAD high dose', 'description': 'PLX-PAD, single administration', 'interventionNames': ['Biological: PLX-PAD']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group B', 'description': 'Placebo, single administration', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'PLX-PAD', 'type': 'BIOLOGICAL', 'description': 'PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells', 'armGroupLabels': ['PLX-PAD high dose', 'PLX-PAD interval high dose', 'PLX-PAD low dose']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo solution for injection', 'armGroupLabels': ['Control Group A', 'Control Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California (USC) - Keck School of Medicine (KSOM)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University Of California Davis,4860 Y Street', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Health Medical Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30907', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College of Georgia at Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '31217', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute, LLC (Mercer University School of Medicine)', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper Research Institute', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Holy Medical Center', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '10467', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11219', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Maimonides Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11570', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pluristem Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}