Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-07 @ 7:00 AM
Study NCT ID:
NCT04884295
Status:
TERMINATED
Last Update Posted:
2022-04-15
First Post:
2021-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for 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': 'C000715115', 'term': 'XVR011'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase 1 is open-label, single ascending dose (completed per protocol); Phase 2 is double-blind, randomised, placebo-controlled (cancelled due to due to change in company strategy for phase II design)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'The sponsor does not intend to start Part 2 (Phase 2) due to change in company strategy for phase 2 design. This early end of trial is not due to reasons of safety or lack of efficacy. Part 1 (Phase 1) is completed as per protocol.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-08', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-05-07', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maximum serum concentration (Cmax)', 'timeFrame': 'Through Day 29', 'description': 'Phase 1'}, {'measure': 'Area under the serum concentration-time curve (AUC)', 'timeFrame': 'Through Day 29', 'description': 'Phase 1'}, {'measure': 'Serum terminal elimination half-life (t1/2)', 'timeFrame': 'Through Day 29', 'description': 'Phase 1'}, {'measure': 'Incidence of anti-drug antibody (ADA) to XVR011', 'timeFrame': 'Through Day 29', 'description': 'Phase 1'}], 'primaryOutcomes': [{'measure': 'Proportion of subjects with Adverse Events (all and serious)', 'timeFrame': 'Through Day 29', 'description': 'Phase 1'}], 'secondaryOutcomes': [{'measure': 'Total duration of oxygen supplementation', 'timeFrame': 'Through Day 29', 'description': 'Phase 1'}, {'measure': 'Proportion of subjects requiring mechanical ventilation and/or ICU transfer', 'timeFrame': 'Through Day 29', 'description': 'Phase 1'}, {'measure': 'Proportion of subjects with COVID-19 related symptoms', 'timeFrame': 'Through Day 29', 'description': 'Phase 1'}, {'measure': 'All-cause mortality rate', 'timeFrame': 'Through Day 29', 'description': 'Phase 1'}, {'measure': 'Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples', 'timeFrame': 'Up to Day 8/ Day of Discharge', 'description': 'Phase 1'}, {'measure': 'Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale)', 'timeFrame': 'Through Day 29', 'description': 'Phase 1'}, {'measure': 'Time to hospital discharge', 'timeFrame': 'Through Day 29', 'description': 'Phase 1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This is a 2 part study where the first part (Phase 1) evaluates the safety of XVR011 and aims to identify the recommended Phase 2 dose. The second part (Phase 2) follows after the part 1 and evaluates whether XVR011 added to standard of care in patients hospitalised for mild to moderate COVID-19 is a safe, well tolerated, and effective treatment.\n\nPart 1 (Phase 1) is completed as per protocol. The sponsor does not intend to start Part 2 (Phase 2) due to change in company strategy for phase 2 design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is ≥ 18 years of age.\n* Tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by RT-PCR and/or antigen test.\n* Had an onset of COVID-19 symptom(s) within 8 days prior to screening; except for dyspnoea and/or tachypnoea for which an onset within 2 days prior to screening is applicable.\n* Requires hospitalisation for medical care.\n* Has oxygen saturation \\>= 91%.\n\nExclusion Criteria:\n\n* Requires non-invasive or invasive mechanical ventilation and/or intensive care.\n* Symptoms consistent with severe COVID-19.\n* Has received a monoclonal antibody, plasma from a person who recovered from COVID-19 or any investigational treatment for COVID-19 within 30 days prior to study treatment.\n* Has received an investigational or approved vaccination against SARS-CoV-2 within 14 days prior to study treatment.\n\nNOTE: Other protocol defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04884295', 'briefTitle': 'Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'ExeVir Bio BV'}, 'officialTitle': 'A 2-part Clinical Study Including a First in Human, Open Label, Single Ascending Dose Part (Phase 1) Followed by a Randomised, Double Blind, Placebo-controlled Part (Phase 2) to Evaluate the Efficacy and Safety of XVR011 in Patients Hospitalised for Mild to Moderate Coronavirus Disease 2019 (COVID-19)', 'orgStudyIdInfo': {'id': 'EXEVIR0101'}, 'secondaryIdInfos': [{'id': '2020-005299-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XVR011', 'description': 'Single Ascending Dose with 3 dose cohorts: low dose - medium dose - high dose (Phase 1)', 'interventionNames': ['Drug: XVR011']}], 'interventions': [{'name': 'XVR011', 'type': 'DRUG', 'description': 'Single dose of XVR011 via intravenous (IV) infusion', 'armGroupLabels': ['XVR011']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'Investigative Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Investigative Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Mechelen', 'country': 'Belgium', 'facility': 'Investigative site', 'geoPoint': {'lat': 51.02574, 'lon': 4.47762}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Investigative site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Investigative Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Investigative site', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ExeVir Bio BV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}