Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-01 @ 7:42 PM
Study NCT ID:
NCT04674566
Status:
UNKNOWN
Last Update Posted:
2022-05-25
First Post:
2020-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2020-12-17', 'studyFirstSubmitQcDate': '2020-12-17', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'through Day 28'}, {'measure': 'Proportion of patients with Serious Adverse Events (SAEs)', 'timeFrame': 'through Day 28'}, {'measure': 'Proportion of patients with Adverse Events of Special Interest (AESI)', 'timeFrame': 'through Day 28'}], 'secondaryOutcomes': [{'measure': 'Secondary efficacy endpoint: Proportion of patients with disease progression', 'timeFrame': 'through Day 28', 'description': 'Proportion of patients who are not alive or have respiratory failure'}, {'measure': 'Secondary efficacy endpoint: Time to negative RT-PCR for SARS-CoV-2', 'timeFrame': 'through Day 28'}, {'measure': 'Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of COR-101', 'timeFrame': 'through Day 60'}, {'measure': 'Assessment of PK parameter: Time to Cmax (tmax) for COR-101', 'timeFrame': 'through Day 60'}, {'measure': 'Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for COR-101', 'timeFrame': 'through Day 60'}, {'measure': 'Assessment of PK parameter: Clearance (CL) for COR-101', 'timeFrame': 'through Day 60'}, {'measure': 'Assessment of PK parameter: Mean residence time (MRT) of COR-101', 'timeFrame': 'through Day 60'}, {'measure': 'Secondary PD endpoint: Change of the viral load of SARS-CoV-2 from baseline, as measured from nasopharyngeal swab samples by qRT-PCR', 'timeFrame': 'through Day 21'}, {'measure': 'Secondary immunogenicity endpoint: Percentage of patients with detectable neutralizing antibodies to COR-101', 'timeFrame': 'through Day 60'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, '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': 'Primary objectives Part 1:\n\n\\- To evaluate the safety and tolerability of COR-101 compared to placebo\n\nSecondary objectives Part 1:\n\n* To evaluate the preliminary efficacy of COR-101 compared to placebo in hospitalized patients with moderate to severe COVID-19\n* To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of COR-101'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Hospitalized for COVID-19 illness for ≤72 hours\n* Positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test\n* Presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID19 prior to study treatment\n\nKey Exclusion Criteria:\n\n* Diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19\n* In the opinion of the investigator, is not likely to survive for \\>48 hours beyond Day 1\n* New onset stroke or seizure disorder during hospitalization and prior to Day 1\n* History of relevant CNS pathology or current relevant CNS pathology'}, 'identificationModule': {'nctId': 'NCT04674566', 'briefTitle': 'Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corat Therapeutics Gmbh'}, 'officialTitle': 'Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, First-in-human, Phase Ib/II Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of COR-101 in Hospitalized Patients', 'orgStudyIdInfo': {'id': 'COR-101/001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'COR-101 low dose', 'interventionNames': ['Drug: COR-101', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'COR-101 mid dose 1', 'interventionNames': ['Drug: COR-101', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'COR-101 mid dose 2', 'interventionNames': ['Drug: COR-101', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'COR-101 high dose', 'interventionNames': ['Drug: COR-101', 'Drug: Placebo']}], 'interventions': [{'name': 'COR-101', 'type': 'DRUG', 'description': 'Administered intravenously (IV) single dose', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered intravenously (IV) single dose', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Helmut Salih', 'role': 'CONTACT'}], 'facility': 'University Hospital Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Marie-Ann Dhaen', 'role': 'CONTACT', 'email': 'm.dhaen@corat-therapeutics.com', 'phone': '+4981313563724'}], 'overallOfficials': [{'name': 'Helmut Salih', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tübingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corat Therapeutics Gmbh', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}