Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT04617535
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2023-10-03
First Post:
2020-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compassionate Use of REGN-COV2 for the Treatment of 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': 'C000711751', 'term': 'casirivimab and imdevimab drug combination'}, {'id': 'C000711487', 'term': 'casirivimab'}, {'id': 'C000711488', 'term': 'imdevimab'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 1}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'lastUpdateSubmitDate': '2023-09-29', 'studyFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2020-11-02', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Post-exposure'], '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': 'Compassionate Use requests will be considered for individuals who test positive for SARS-CoV-2 and where there is reasonable basis to believe that the patient is infected with a susceptible variant.', 'detailedDescription': 'Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT']}, 'identificationModule': {'nctId': 'NCT04617535', 'briefTitle': 'Compassionate Use of REGN-COV2 for the Treatment of COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'orgStudyIdInfo': {'id': 'R10933-10987-COV'}}, 'armsInterventionsModule': {'interventions': [{'name': 'REGN10933+REGN10987 combination therapy', 'type': 'DRUG', 'otherNames': ['REGN-COV2', 'Casirivimab', 'Imdevimab', 'REGEN-COV™', 'Ronapreve™'], 'description': 'Administered intravenously (IV) single dose'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}