Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT04528667
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
2020-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C000630672', 'term': 'abivertinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 396}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-01', 'studyFirstSubmitDate': '2020-08-20', 'studyFirstSubmitQcDate': '2020-08-25', 'lastUpdatePostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects discharged from hospital', 'timeFrame': 'Randomization through Day 29', 'description': 'Proportion of subjects whoa re alive and discharged from the hospital by Day 29'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events (safety)', 'timeFrame': 'Randomization through study completion through Day 36', 'description': 'Types, frequencies, and severities of adverse events and their relationships to STI-5656, including serious adverse events'}, {'measure': 'Time to hospital admission, treatment, and discharge', 'timeFrame': 'Randomization through study completion through Day 36', 'description': 'Time from onset of COVID-19 symptoms to hospital admission, time from hospitalization to start of treatment (D1), and time from D1 to hospital discharge'}, {'measure': 'Number of days hospitalized', 'timeFrame': 'Randomization to Day 36', 'description': 'Number of days hospitalized from randomization through Day 36'}, {'measure': 'Change in clinical status as assessed using a 0-8 ordinal scale', 'timeFrame': 'Randomization to Day 3, Day 10, and Day 36', 'description': 'Change in clinical status as assessed using a 0-8 ordinal scale, where a lower score equals better outcome, at Days 3, 10, and 36'}, {'measure': 'Change in RT-PCR test results', 'timeFrame': 'Randomization to Day 3, Day 10, and Day 36', 'description': 'Change in RT-PCR test results (or equivalent) at Days 3, 10, and 36'}, {'measure': 'Change in C-reactive protein levels', 'timeFrame': 'Randomization to Day 3 and Day 10', 'description': 'Change in C-reactive protein (CRP) levels at Day 3 and Day 10'}, {'measure': 'AUC of STI-5656 (PK)', 'timeFrame': 'Randomization through Day 8', 'description': 'Area under the serum concentration-time curve (AUC) of STI-5656'}, {'measure': 'Cmax of STI-5656 (PK)', 'timeFrame': 'Randomization through Day 8', 'description': 'Maximum observed serum concentration (Cmax) of STI-5656'}, {'measure': 't½ of STI-5656 (PK)', 'timeFrame': 'Randomization through Day 8', 'description': 'Apparent serum terminal elimination half life (t½) of STI-5656'}, {'measure': 'Change in cytokine levels', 'timeFrame': 'Randomization to Day 3 and Day 10', 'description': 'Change in cytokine levels (including IL-6, TNF-a, IFNγ, IL1β) at Day 3 and Day 10'}, {'measure': 'Tmax of STI-5656 (PK)', 'timeFrame': 'Randomization through Day 8', 'description': 'Time to Cmax (Tmax) of STI-5656'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid-19'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19', 'detailedDescription': 'This is a phase 2, randomized, double-blind, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19 in Brazil. Subjects are randomized 3:1 STI-5656 to placebo. Subjects receive either 100 mg of STI-5656 or placebo daily for 7 days. Standard of care will be maintained for all subjects throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed positive for COVID-19 by RT-PCR assay or equivalent\n* Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board (IRB) or independent ethics committee (IEC) approved consent form prior to participating in any study related activity. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27, 2020 (Updated on July 2, 2020) FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used\n* Able to swallow capsules\n* Willing to follow contraception guidelines\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Suspected uncontrolled active bacterial, fungal, viral, or other infection other than COVID-19\n* Treatment with a strong cytochrome p450 3A4 inhibitor or inducer within 7 days prior to Day 1\n* Received anti-rejection or immunomodulatory drugs within 14 days prior to Day 1\n* Concurrent participation in another clinical trial involving therapeutic interventions (observation studies are acceptable)\n* Any condition that confounds the ability to interpret data from the study\n* Any significant medical condition, laboratory abnormality, or psychiatric illness that would interfere with or prevent the subject from participating in the study'}, 'identificationModule': {'nctId': 'NCT04528667', 'briefTitle': 'Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sorrento Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19', 'orgStudyIdInfo': {'id': 'BTK-COV-202BR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STI-5656', 'description': 'STI-5656 (abivertinib maleate) capsules administered orally 100 mg QD for 7 days, in addition to standard of care', 'interventionNames': ['Drug: STI-5656']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsules administered orally daily for 7 days, in addition to standard of care', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'STI-5656', 'type': 'DRUG', 'otherNames': ['abivertinib maleate', 'avitinib', 'AC0010', 'abivertinib'], 'description': 'STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor.', 'armGroupLabels': ['STI-5656']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital e Maternidade Christovão da Gama', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}], 'overallOfficials': [{'name': 'Mike Royal, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sorrento Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorrento Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}