Viewing Study NCT05624450

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Ignite Creation Date: 2025-12-24 @ 4:59 PM
Ignite Modification Date: 2026-02-20 @ 11:49 PM
Study NCT ID: NCT05624450
Status: RECRUITING
Last Update Posted: 2025-11-17
First Post: 2022-11-11
Is NOT Gene Therapy: True
Has Adverse Events: False
Brief Title: Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2870}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2022-11-11', 'studyFirstSubmitQcDate': '2022-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)', 'timeFrame': 'by Day 28', 'description': 'To evaluate the effect of tozorakimab versus placebo as an add on to Standard of Care (SoC) in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO.'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants who die', 'timeFrame': 'by Day 60', 'description': 'To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on all-cause mortality.'}, {'measure': 'Number of days alive and outside of Intensive Care Unit (ICU)', 'timeFrame': 'over 28 day period', 'description': 'To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU stay.'}, {'measure': 'Number of days alive and free of supplemental oxygen', 'timeFrame': 'over 28 day period', 'description': 'To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on the duration of oxygen supplementation.'}, {'measure': 'Time to death or progression to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)', 'timeFrame': 'over 28 day and 60 day period', 'description': 'To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on prolonging time to death or IMV/ECMO.'}, {'measure': 'Proportion of participants who die or progress to Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)', 'timeFrame': 'by Day 60', 'description': 'To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on prolonging time to death or IMV/ECMO.'}, {'measure': 'Time to death (all cause)', 'timeFrame': 'over 28 day and 60 day period', 'description': 'To evaluate the effect of Tozorakimab versus Placebo as add-on to Standard of Care (SoC) on prolonging time to death.'}, {'measure': 'Proportion of participants who die', 'timeFrame': 'by Day 28', 'description': 'To evaluate the effect of Tozorakimab versus Placebo as add-on to Standard of Care (SoC) on prolonging time to death.'}, {'measure': 'Number of days alive and free of Invasive Mechanical Ventilation (IMV) / Extracorporeal Membrane Oxygen (ECMO)', 'timeFrame': 'over 28 day and 60 day period', 'description': 'To evaluate the effect of Tozorakimab versus placebo as add-on to Standard of Care (SoC) on ventilator use.'}, {'measure': 'Number of days alive and ventilator free', 'timeFrame': 'over 28 day and 60 day period', 'description': 'To evaluate the effect of Tozorakimab versus placebo as add-on to Standard of Care (SoC) on ventilator use.'}, {'measure': 'Proportion of participants with Intensive Care Unit (ICU) admission or death', 'timeFrame': 'by Day 28', 'description': 'To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU admissions.'}, {'measure': 'Proportion of participants with Intensive Care Unit (ICU) admission or death', 'timeFrame': 'by Day 60', 'description': 'To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on ICU admissions.'}, {'measure': 'Proportion of participants alive and discharged', 'timeFrame': 'by Day 28', 'description': 'To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.'}, {'measure': 'Proportion of participants alive and discharged', 'timeFrame': 'by Day 60', 'description': 'To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.'}, {'measure': 'Time to discharge', 'timeFrame': 'over 28 day and 60 day period', 'description': 'To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.'}, {'measure': 'Time to being off supplemental oxygen', 'timeFrame': 'over 28 day and 60 day period', 'description': 'To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on duration of hospitalisation.'}, {'measure': 'World Health Organization (WHO) 10-category ordinal Clinical Progression Scale', 'timeFrame': 'by Day 60', 'description': 'To evaluate the effect of tozorakimab versus placebo as add-on to Standard of Care (SoC) on clinical status as assessed by the Investigator using WHO 10-category ordinal Clinical Progression Scale (0 least severe to 10 most severe).'}, {'measure': 'Presence of anti-drug antibodies', 'timeFrame': 'over 60 day period', 'description': 'To evaluate the immunogenicity (presence of tozorakimab anti-drug antibodies in blood serum) in participants with viral lung infection requiring supplemental oxygen.'}, {'measure': 'Baseline serum interleukin-33/soluble Suppression of Tumorgenicity 2 (IL-33/sST2) complex levels relative to primary endpoint', 'timeFrame': 'Day 1', 'description': 'To evaluate the use of baseline serum IL-33/sST2 complex levels (U/mL) to predict treatment response with tozorakimab versus placebo as add on to Standard of Care (SoC).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Respiratory Failure', 'Acute Respiratory Distress Syndrome', 'Viral lung infection', 'Tozorakimab', 'Supplemental Oxygen', 'IL-33', 'COVID-19', 'SARS-CoV-2', 'Coronavirus Infections', 'Virus Diseases', 'SARS Coronavirus', 'MEDI3506', 'Respiratory Tract Infections', 'Infections', 'Lung Diseases', 'Influenza'], 'conditions': ['Viral Lung Infection and Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult participants ≥ 18 years old at the time of signing the informed consent form.\n* Patients hospitalised with viral lung infection.\n* Hypoxaemia requiring treatment with supplemental O2.\n\nHypoxaemia is defined as:\n\nSpO2 ≤ 90% OR\n\nSpO2 ≤ 92% AND one or both of the following:\n\nRadiographic infiltrates by CXR/CT compatible with viral lung infection per investigator judgement.\n\nUse of accessory muscles of respiration or RR (respiratory rate) \\> 22.\n\n\\- Patient remains hypoxaemic at randomisation requiring treatment with supplemental oxygen.\n\nExclusion Criteria:\n\n* Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or evidence of septic shock. Bacterial co-infection is allowed, unless, in the opinion of the investigator, bacterial infection defines the severity of the participant's condition.\n* Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology.\n* Ongoing IMV/ECMO at randomisation."}, 'identificationModule': {'nctId': 'NCT05624450', 'acronym': 'TILIA', 'briefTitle': 'Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen', 'orgStudyIdInfo': {'id': 'D9185C00001'}, 'secondaryIdInfos': [{'id': '2023-507031-38-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': '2022-003107-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tozorakimab', 'description': 'Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab.', 'interventionNames': ['Drug: Tozorakimab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1435) will receive matching placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tozorakimab', 'type': 'DRUG', 'otherNames': ['MEDI3506'], 'description': 'Single IV dose of tozorakimab on Day 1.', 'armGroupLabels': ['Tozorakimab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single IV dose of matching placebo on Day 1.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '93701', 'city': 'Fresno', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 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