CTRI/2023/09/058035招募中3 期
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 (TILIA).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Adult participants = 18 years old at the time of signing the ICF.
- •Type of Participant and Disease Characteristics
- •2.Patients hospitalised with viral lung infection. Note: Suspected viral aetiology is acceptable to meet this criterion.
- •3.Hypoxaemia requiring treatment with supplemental O2, consistent with WHO Clinical Progression Scale for Disease Progression score of 5 and 6.
- •Note: Hypoxemia is defined as SpO2 = 94% on room air at screening, or documented SpO2 = 94% prior to initiation of oxygen therapy. Patients receiving oxygen > 6 L/min or non-invasive ventilation will be considered to have met this inclusion criterion regardless of SpO2 levels.
- •4.= 36 hours since admission to hospital.
- •5.= 14 days since onset of respiratory viral infection symptoms.
排除标准
- •Medical Conditions
- •1Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or pulmonary sepsis. Bacterial co infection is allowed, unless, in the opinion of the investigator, bacterial infection defines the severity of the participants condition.
- •2Hypoxaemia caused primarily by extrapulmonary insult (eg, multiorgan failure, shock, or sepsis) or by lung injury of non infective aetiology (eg, trauma, chemical injury, etc).
- •3Ongoing or impending IMV/ECMO at randomisation (ie, WHO Clinical Progression Scale score = 7).
- •4Any comorbid condition that, in the opinion of the investigator, is likely to result in death within 3 months from randomisation.
- •5Anticipated recovery and discharge from the hospital within 24 hours of randomisation.
- •6Active tuberculosis defined as requiring current treatment.
- •7Known unstable cardiovascular disease (eg, unstable chronic heart failure NYHA III-IV, recent myocardial infarction or stroke within 3 months, or uncontrolled ventricular arrythmia) that in the investigator s judgement may put the participant at risk or negatively affect the outcome of the study.
- •8Known absolute neutrophil count = 1.0 x 109/L.
- •9Untreated HIV. Known history of active hepatitis B or C (treated and controlled hepatitis is allowed).
- •10Known history of active severe inflammatory bowel disease or colitis (including Crohn disease or ulcerative colitis).
- •11Malignancy, current or within the past 5 years, except for adequately treated non invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment.
- •12Any disorder that is not stable in the opinion of the investigator, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious (including risk factors for viral lung infection), endocrine, metabolic, haematological, immune, psychiatric, or major physical impairment and could:
- •a. affect the safety of the participant throughout the study,
- •b. influence the findings of the study or their interpretation,
- •c. impede the participant s ability to complete the entire duration of the study.
- •Prior/Concomitant Therapy
- •13Use of long-term oxygen therapy for pre-existing conditions.
- •14Chronic treatment with TNF inhibitors, Janus kinase inhibitors or interferon gamma. Wash-out period of 4 weeks or 5 half-lives (whichever is longer) is required prior to enrolment.
- •15Current treatment with any investigational medication. Wash-out period of 4 weeks or 5 half-lives (whichever is longer) is required prior to prior to enrolment.
- •16Participants who have previously received tozorakimab.
- •17Known history of:
- •a. anaphylaxis to any other biologic therapy,
- •b. severe reaction to any medication including biologic agents or human gamma globulin therapy,
- •c. allergy or reaction to any component of the study intervention formulation.
- •Contraception
- •18Pregnant and lactating participants.
- •19Male participants who are sexually active with a FOCBP and participants that are FOCBP who are sexually active with a male partner, unless they agree to use highly effective contraceptive methods from enrolment throughout the study and until at least 14 weeks after last dose of IP.
研究者
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