Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-29 @ 2:31 AM
Study NCT ID:
NCT04770467
Status:
WITHDRAWN
Last Update Posted:
2023-03-03
First Post:
2021-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With 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': 'C000721042', 'term': 'amubarvimab'}, {'id': 'C000721043', 'term': 'romlusevimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study will no longer move forward due to recent changes in COVID-19 cases in Hong Kong.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2021-02-22', 'studyFirstSubmitQcDate': '2021-02-24', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events (AEs)', 'timeFrame': 'Day 29'}, {'measure': 'Incidence of serious adverse events (SAEs)', 'timeFrame': 'up to Day 29'}, {'measure': 'Change from pre-dose baseline in RBC count', 'timeFrame': 'Day 29'}, {'measure': 'Change from pre-dose baseline in WBC count', 'timeFrame': 'Day 29'}, {'measure': 'Change from pre-dose baseline in Platelets count', 'timeFrame': 'Day 29'}, {'measure': 'Change from pre-dose baseline in Hemoglobin result', 'timeFrame': 'Day 29'}, {'measure': 'Change from pre-dose baseline in Creatine kinase result', 'timeFrame': 'Day 29'}, {'measure': 'Change from pre-dose baseline in Alanine aminotransferase (ALT) result', 'timeFrame': 'Day 29'}, {'measure': 'Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8', 'timeFrame': 'Day 8'}], 'secondaryOutcomes': [{'measure': 'Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19', 'timeFrame': 'up to Day 29'}, {'measure': 'Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization', 'timeFrame': 'up to 72 weeks'}, {'measure': 'Assessment of PK parameters: maximum serum concentration observed (Cmax)', 'timeFrame': 'up to Day 85'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 phase 2', 'monoclonal antibody'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety, efficacy and pharmacokinetics profile of human monoclonal antibodies, BRII-196 and BRII-198 compared with placebo in patients with COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject ≥ 18 years, signing the informed consent.\n* SARS-CoV-2 infection by PCR ≤ 7 days\n* One or more of COVID-19 related symptoms or measured fever present within 48 hours prior to study entry (subjects with mild-moderate COVID-19)\n\nExclusion Criteria:\n\n* Recurring COVID-19 patients.\n* Subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent\n* Receipt of convalescent COVID-19 plasma, SARS-CoV-2 mAb treatment, SARS-CoV-2 vaccine, or other investigational treatments prior to study entry.'}, 'identificationModule': {'nctId': 'NCT04770467', 'briefTitle': 'A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Brii Biosciences Limited'}, 'officialTitle': 'A Phase 2, Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients', 'orgStudyIdInfo': {'id': 'BRII-196-198-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BRII-196 and BRII-198 in adult subjects with severe COVID-19', 'interventionNames': ['Drug: BRII-196 and BRII-198']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo in adult subjects with severe COVID-19', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19', 'interventionNames': ['Drug: BRII-196 and BRII-198']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo in adult subjects with mild-moderate COVID-19', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BRII-196 and BRII-198', 'type': 'DRUG', 'description': 'BRII-196 and BRII-198 given by intravenous administration', 'armGroupLabels': ['BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19', 'BRII-196 and BRII-198 in adult subjects with severe COVID-19']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo given by intravenous administration', 'armGroupLabels': ['Placebo in adult subjects with mild-moderate COVID-19', 'Placebo in adult subjects with severe COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Investigative Site 1', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Yao Zhang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Brii Biosciences, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brii Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}