Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT04860518
Status:
TERMINATED
Last Update Posted:
2023-07-21
First Post:
2021-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}}}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C428112', 'term': 'peginterferon beta-1a'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'juho.jalkanen@faron.com', 'phone': '+358407071046', 'title': 'Dr Juho Jalkanen', 'organization': 'Faron'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'No formal statistical hypotheses were analysed due the early termination of the study with only 5 dosed subjects.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.', 'description': 'All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.', 'eventGroups': [{'id': 'EG000', 'title': 'IV IFN Beta-1a', 'description': 'Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.\n\nIFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'IV Dexamethasone', 'description': 'Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.\n\nDexamethasone: Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypnoatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Subdural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'seriousEvents': [{'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV IFN Beta-1a', 'description': 'Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.\n\nIFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised'}, {'id': 'OG001', 'title': 'IV Dexamethasone', 'description': 'Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.\n\nDexamethasone: Treated daily with dexamethasone as an IV bolus for 6 days while hospitalised'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '0', 'groupId': 'OG000'}, {'value': '2', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'WHO 9-point ordinal scale:\n\n0 - No detectable infection\n\n1. \\- Not hospitalized, no limitations on activities\n2. \\- Not hospitalized, limitation on activities\n3. \\- Hospitalized, not requiring supplemental oxygen\n4. \\- Hospitalized, requiring supplemental oxygen\n5. \\- Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. \\- Hospitalized, on invasive mechanical ventilation\n7. \\- Hospitalized, on mechanical ventilation plus additional organ support: renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO)\n8. \\- Death', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 4 patients had analyzable data on D14'}, {'type': 'SECONDARY', 'title': 'In-hospital Mortality at Day 28 and Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV IFN Beta-1a', 'description': 'Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.\n\nIFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised'}, {'id': 'OG001', 'title': 'IV Dexamethasone', 'description': 'Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.\n\nDexamethasone: Treated daily with dexamethasone as an IV bolus for 6 days while hospitalised'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28 and Day 90', 'description': 'Percentage of participants per study group that die when in still hospital at Day 28 or Day 90 of the trial', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall (All-cause) Mortality at Day 28 and Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV IFN Beta-1a', 'description': 'Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.\n\nIFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised'}, {'id': 'OG001', 'title': 'IV Dexamethasone', 'description': 'Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.\n\nDexamethasone: Treated daily with dexamethasone as an IV bolus for 6 days while hospitalised'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28 and Day 90', 'description': 'Percentage of participants per study group that die within 28 days or 90 days from starting the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IV IFN Beta-1a', 'description': 'Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.\n\nIFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised'}, {'id': 'FG001', 'title': 'IV Dexamethasone', 'description': 'Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.\n\nDexamethasone: Treated daily with dexamethasone as an IV bolus for 6 days while hospitalised'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Screen Failure, patient was not dosed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IV IFN Beta-1a', 'description': 'Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.\n\nIFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised'}, {'id': 'BG001', 'title': 'IV Dexamethasone', 'description': 'Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.\n\nDexamethasone: Treated daily with dexamethasone as an IV bolus for 6 days while hospitalised'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'spread': '7.00', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '15.69', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '12.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White and Other (not specified)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) status', 'classes': [{'title': '0: Able to carry out all normal activity without restriction', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': '2: Ambulatory and capable of all self-care but unable to carry out any work activities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-27', 'size': 2688905, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-25T07:57', 'hasProtocol': True}, {'date': '2022-04-21', 'size': 534627, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-25T07:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study will be performed in a double-blind and randomized manner.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'The decision is based on changes in the pandemic and further weakening of the recruitment that will not enable a completion of the study in any reasonable time', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2021-04-22', 'resultsFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-12', 'studyFirstPostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale', 'timeFrame': 'Day 14', 'description': 'WHO 9-point ordinal scale:\n\n0 - No detectable infection\n\n1. \\- Not hospitalized, no limitations on activities\n2. \\- Not hospitalized, limitation on activities\n3. \\- Hospitalized, not requiring supplemental oxygen\n4. \\- Hospitalized, requiring supplemental oxygen\n5. \\- Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. \\- Hospitalized, on invasive mechanical ventilation\n7. \\- Hospitalized, on mechanical ventilation plus additional organ support: renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO)\n8. \\- Death'}], 'secondaryOutcomes': [{'measure': 'In-hospital Mortality at Day 28 and Day 90', 'timeFrame': 'Day 28 and Day 90', 'description': 'Percentage of participants per study group that die when in still hospital at Day 28 or Day 90 of the trial'}, {'measure': 'Overall (All-cause) Mortality at Day 28 and Day 90', 'timeFrame': 'Day 28 and Day 90', 'description': 'Percentage of participants per study group that die within 28 days or 90 days from starting the study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This double-blinded, randomized study is being conducted to see if the investigational new drug called FP-1201-lyo - intravenous Interferon beta-1a, hereafter IV IFN beta-1a, can help patients recover more quickly from COVID-19 and prevent worsening of the condition. To understand if IV IFN beta-1a can help treat patients with COVID-19, this study drug will be compared to dexamethasone.\n\nStudy subjects will be treated daily with IV IFN beta-1a 10 μg or IV dexamethasone for 6 consecutive days while hospitalized and will undergo daily assessments while in hospital for a maximum of 28 days. Study specific assessments will be collected at pre-dose Day 1 through Day 28 (PD and PIM assessments), in addition, clinical routine assessments will be utilized for safety and efficacy assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years\n2. Positive SARS-CoV-2 test by PCR (polymerase chain reaction) or other diagnostic method within the past 7 days\n3. Admission to hospital with respiratory symptoms of COVID-19 requiring hospital care and oxygen supplementation (≤ 8L/min)\n4. Respiratory symptom onset no more than 7 days prior to hospital arrival\n5. Informed consent from the subject or the subject's personal legal representative or a professional legal representative must be available\n\nExclusion Criteria:\n\n1. Unable to screen, randomize and administer study drug within 48 hours from arrival to hospital\n2. Systemic corticosteroid, baricitinib or tofacitinib (or other JAK-STAT signalling pathway inhibitors) therapy within 7 days prior to arrival to hospital or planned for the next days\n3. Known hypersensitivity or contraindication to natural or recombinant IFN-beta-1a or its excipients, or to dexamethasone or its excipients\n4. Currently receiving IFN-beta-1a therapy\n5. Home assisted ventilation (via tracheotomy or non-invasive) except for Continuous Positive Airway Pressure (CPAP) / Bilevel Positive Airway Pressure (BIPAP) used only for sleep-disordered breathing\n6. Participation in another concurrent interventional pharmacotherapy trial during the study period\n7. Decision to withhold life-sustaining treatment; patient not committed to full support (except DNR after cardiac arrest only)\n8. Woman known to be pregnant, lactating or with a positive pregnancy test (urine or serum test)\n9. Subject is not expected to survive for 24 hours\n10. Subject has liver failure (Child-Pugh grade C)\n11. Any clinical condition that in the opinion of the attending clinician or Investigator would present a risk for the subject to participate in the study"}, 'identificationModule': {'nctId': 'NCT04860518', 'acronym': 'HIBISCUS', 'briefTitle': 'Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Faron Pharmaceuticals Ltd'}, 'officialTitle': 'A Phase II Multi-Center, Double-Blind, Randomized and Controlled Study of the Safety and Efficacy of Intravenous Recombinant Human Interferon Beta-1a in Comparison to Dexamethasone for the Treatment of Hospitalized Patients With COVID-19 Infection', 'orgStudyIdInfo': {'id': 'FP1CLI017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV IFN beta-1a', 'description': 'Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.', 'interventionNames': ['Drug: IFN beta-1a']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV Dexamethasone', 'description': 'Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'IFN beta-1a', 'type': 'DRUG', 'description': 'Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised', 'armGroupLabels': ['IV IFN beta-1a']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised', 'armGroupLabels': ['IV Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02462', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Newton-Wellesley Hospital', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University School of Medicine', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Daniel Talmor, MD MPH,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deaconess Medical Center, Spokane, Washington'}, {'name': 'Adit Ginde, MD MPH,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faron Pharmaceuticals Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}