Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT04526912
Status:
TERMINATED
Last Update Posted:
2021-12-17
First Post:
2020-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Study met predefined futility criteria for efficacy endpoints.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-16', 'studyFirstSubmitDate': '2020-08-21', 'studyFirstSubmitQcDate': '2020-08-21', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness', 'timeFrame': 'Day 1 (Baseline) through Day 28', 'description': 'Critical illness is defined by respiratory failure (requiring any of the following: endotracheal intubation, oxygen delivered by high flow nasal cannula, non-invasive positive pressure ventilation, extracorporeal membrane oxygenation or clinical diagnosis of respiratory failure) or shock (systolic blood pressure \\< 90 mm Hg, or diastolic blood pressure \\< 60 mm Hg, or requiring vasopressors)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent fatal and life-threatening SAEs, Treatment-emergent Serious Adverse Events', 'timeFrame': 'Day 1 (Baseline) through Day 70', 'description': 'Defined as measure of safety'}, {'measure': 'Change in safety laboratory parameters', 'timeFrame': 'Day 1 (Baseline) through Day 70', 'description': 'Safety evaluation via review of labs (white blood cell (WBC) with differential counts, hemoglobin, platelet count, liver function tests (aspartate aminotransferase \\[AST\\], alanine aminotransferase \\[ALT\\], and total bilirubin levels), serum chemistry, cardiac troponin coagulation markers (prothrombin time \\[PT\\], partial thromboplastin time \\[PTT\\], D dimer, fibrinogen), and urinalysis)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pneumonia', 'COVID-19', 'SARS-Cov-2', 'acute respiratory disease'], 'conditions': ['Acute Lung Injury']}, 'descriptionModule': {'briefSummary': 'The study aims to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Subjects will be administered a single dose of VIB7734 injected under the skin, assessed for efficacy for 28 days and followed for an additional 42 days.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled study intended to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Efficacy will be assessed during the 28 days following a single administration of VIB7734. Safety will be assessed for 10 weeks following dosing. The pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of VIB7734 in patients with confirmed SARS-CoV-2 infections will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Hospitalized with coronavirus disease 2019 (COVID-19) pneumonia confirmed by World Health Organization criteria.\n* Oxygen saturation ≤ 94% at room air or arterial partial pressure of oxygen/fraction of inspired oxygen \\< 300 mm Hg and \\> 200 mm Hg.\n* Negative influenza test.\n* Lymphocyte counts \\< 10\\^3/μL and the presence of at least one of the following markers of hyperinflammation within 1 day prior to VIB7734 administration:\n\n * Elevated high sensitivity C-reactive protein (hsCRP) \\> 50 mg/L\n * Ferritin \\> 500 ng/mL\n * Lactate dehydrogenase (LDH) \\> 300 U/L\n * D-dimers \\> 500 ng/mL\n\nNOTE: Other protocol defined inclusion criteria apply\n\nKey Exclusion Criteria:\n\n* Respiratory failure requiring mechanical ventilation.\n* In the opinion of the Investigator, progression to mechanical ventilation or death is imminent and inevitable within the next 24 hours.\n* Valid Do Not Intubate (DNI) or Do Not Resuscitate (DNR) order.\n* Anticipated duration of hospital stay \\< 72 hours.\n* History of allergy or hypersensitivity reaction to any component of the IP.\n* Participation in another clinical study with an IP within 4 weeks prior to Day 1 or within 5 half-lives of the IP, whichever is longer. (Participation in COVID-19 antiviral or antimalarial trials may be permitted after discussion with the Medical Monitor).\n* Liver cirrhosis or liver failure.\n* Known human immunodeficiency virus infection.\n* Known hepatitis B or known hepatitis C infection in the absence of a history of curative therapy.\n* Known or suspect active or latent tuberculosis infection.\n* Active bacterial, fungal, viral, or other infection (besides COVID-19).\n* Clinically significant cardiac disease within 6 months.\n* History of severely impaired respiratory function at baseline (not related to COVID-19) based on requirement for home oxygen of \\> 4 L/min or based on other medical history known to the Investigator.\n* History of cancer within 12 months of enrollment.\n* Receipt of chemotherapy, biologic immunomodulators (including JAK inhibitors), or immunosuppressive therapies within 8 weeks of enrollment, or receipt of rituximab or other B cell-depleting mAb therapy within 6 months.\n\nNOTE: Other protocol defined exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04526912', 'acronym': 'ALI', 'briefTitle': 'Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viela Bio (acquired by Horizon Therapeutics)'}, 'officialTitle': 'A Proof of Concept Study of the Safety and Efficacy of VIB7734 for the Treatment and Prevention of Acute Lung Injury (ALI) in Patients With SARS-CoV-2 Infection', 'orgStudyIdInfo': {'id': 'VIB7734.P1.S2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIB7734 Dose', 'description': 'Participants will receive a single subcutaneous dose of VIB7734.', 'interventionNames': ['Drug: VIB7734']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a single subcutaneous dose of placebo (saline) matched to single dose of VIB7734.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VIB7734', 'type': 'DRUG', 'description': 'Single subcutaneous dose', 'armGroupLabels': ['VIB7734 Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intravenous single dose matched to VIB7734.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Gábor Illei, MD, PhD, MHS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vice President, Clinical Development Lead'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Viela Bio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}