NCT06999603终止2 期
A Phase 2, Two-part Study to Assess the Safety, Antiviral Biomarker Responses, and Efficacy of Inhaled SNG001 for the Treatment of Patients With a Confirmed Respiratory Virus Infection Undergoing Invasive Mechanical Ventilation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 77
- 主要终点
- Part 1: AE and SAE Severity
研究概览
简要总结
The goal of this Phase 2 study is to assess the safety, antiviral biomarker responses and efficacy of SNG001 when given to patients requiring invasive mechanical ventilation due to a respiratory virus infection. Its ability to speed up virus clearance and reduce mortality, compared with standard of care, will be studied.
The study is split into two parts. All participants will receive standard of care in addition to SNG001 or placebo.
In Part 1, the safety of SNG001 will be assessed. Participants of 50 years and older will receive study drug or placebo once a day for up to 14 days, whilst in hospital.
In Part 2, the primary objective will be the efficacy of SNG001. Participants between 18 and 50 years with an immunocompromising condition and patients over 50 years (with or without an immunocompromising condition) will receive study drug once a day for up to 14 days, whilst in hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Part 1 Inclusion Criteria:
- •To be eligible for randomisation into Part 1 of this study, each participant must fulfil the following criteria:
- •Informed consent or legal representative's consent obtained.
- •Patients ≥50 years of age at the time of consent.
- •Patient admitted to the ICU and requiring invasive mechanical ventilation (IMV) due to a respiratory virus infection.
- •Presence of Influenza A (Flu A), Influenza B (Flu B), respiratory syncytial virus (RSV), rhinovirus (RV), adenovirus, parainfluenza, human metapneumovirus (HMPV), or coronaviruses (including SARS-COV-2 and seasonal coronaviruses) in a nose swab sample, confirmed by a positive virus test using a Sponsor approved rapid POC test (e.g., reverse transcription polymerase chain reaction [RT-PCR]).
- •Time from intubation to administration of first dose of study medication ≤48 hours.
- •Women of childbearing potential must have a negative pregnancy test. For this study, women of childbearing potential are defined as women <55 years old.
排除标准
- •A participant must not be randomised into Part 1 of the study if they meet any of the following criteria:
- •Expected termination of IMV within 24 hours from the time of randomisation
- •Life expectancy <24 hours.
- •Liver failure (Child-Pugh C).
- •Severe congestive heart failure (New York Heart Association [NYHA] IV).
- •Receipt of lung transplant.
- •Known or suspected active tuberculosis, or infection with other mycobacteria
- •Known or suspected active systemic fungal infection.
- •Anticipated transfer to another hospital which would prevent the participant from continuing in the study and completing protocol assessments.
- •Need for long-term mechanical ventilation prior to ICU admission.
- •Use of inhaled sedation.
- •Presence of tracheostomy or laryngectomy.
- •Requirement for airway pressure release ventilation mode.
- •History of hypersensitivity to natural or recombinant IFNβ or to any of the excipients in the drug preparation.
- •Any condition, including findings in the patient's medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation.
- •Participation in previous clinical studies of SNG
- •Current or previous participation in another clinical study where the participant has received a dose of an Investigational Medicinal Product (IMP) containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study.
- •Known or suspected pregnancy.
- •Females who are breast-feeding or lactating.
- •Immunocompromising condition, including:
- •Established acquired immune deficiency syndrome (AIDS) defined as a cluster of differentiation 4 (CD4) count <200 cells/microL, and/or the presence of any AIDS-defining condition;
- •Haematological malignancy;
- •Bone marrow transplantation; or
- •Immunosuppressive therapy, including:
- •Cancer therapy (e.g. chemo-, radio-, immuno-, hormone or other types of therapy), immune-cell depleting therapy, immunosuppressive therapy for autoimmune disorders, medications for prevention of organ transplantation rejection, administered within 6 months prior to randomisation; or
- •Corticosteroids >20 mg of prednisone or equivalent per day administered continuously for >14 days prior to randomisation.
- •Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis.
- •Part 2 Inclusion Criteria:
- •To be eligible for randomisation into Part 2 of this study, each participant must fulfil the following criteria:
- •1.a Patients ≥18 and <50 years of age at the time of consent, with an immunocompromising condition, including:
- •Solid tumour malignancy undergoing cancer therapy (e.g. chemo-, radio-, immuno-, hormone or other types of therapy);
- •Haematological malignancy in remission, with or without maintenance therapy;
- •Immunosuppressive therapy for autoimmune disease;
- •Therapy for prevention of organ transplant rejection;
- •Corticosteroids >20 mg of prednisone or equivalent per day, administered continuously for >14 days prior to randomisation or
- •b Patients ≥50 years of age at the time of consent, with or without an immunocompromising condition (as defined above).
- •Patient admitted to the ICU and requiring IMV due to a respiratory virus infection.
- •Presence of Flu A, Flu B, RSV, RV, adenovirus, parainfluenza, HMPV, or coronaviruses (including SARS-COV-2 and seasonal coronaviruses) in a Lower Respiratory Tract sample, confirmed by a positive virus test using a Sponsor approved rapid POC test (e.g., RT-PCR).
- •Time from intubation to administration of first dose of study medication ≤48 hours.
- •Informed consent or legal representative's consent obtained.
- •Women of childbearing potential must have a negative pregnancy test. For this study, women of childbearing potential are defined as women <55 years old.
- •Part 2 Exclusion Criteria:
- •A participant must not be randomised into Part 2 of the study if they meet any of the following criteria:
- •Expected termination of IMV within 24 hours from the time of randomisation.
- •Life expectancy <24 hours.
- •Liver failure (Child-Pugh C).
- •Severe congestive heart failure (NYHA IV).
- •Receipt of lung transplant.
- •Known or suspected active tuberculosis, or infection with other mycobacteria.
- •Known or suspected systemic fungal infection.
- 另有 22 项未显示
研究组 & 干预措施
Part 1 Safety Evaluation of SNG001 (Placebo)
Placebo Comparator
Participants will inhale a dose of placebo matched to SNG001 (only excipients of the SNG001 solution) via the nebuliser, once a day for up to 14 days.
干预措施: Placebo (Drug)
Part 2 Efficacy evaluation of SNG001 (Placebo)
Placebo Comparator
Participants will inhale a dose of placebo matched to SNG001 (only excipients of the SNG001 solution) via the nebuliser, once a day for up to 14 days
干预措施: Placebo (Drug)
Part 1 Safety Evaluation of SNG001
Experimental
Participants will inhale a dose of SNG001 via the nebuliser, once a day for up to 14 days. A first, single syringe, low-dose cohort may be followed by an optional second cohort utilising a two-syringe dose.
干预措施: SNG001 (Drug)
Part 2 Efficacy Evaluation of SNG001
Experimental
Participants will inhale the higher (two-syringe) dose of SNG001 via the nebuliser, once a day for up to 14 days.
干预措施: SNG001 (Drug)
结局指标
主要结局
Part 1: AE and SAE Severity
时间窗: Up to 28 days from randomisation
The occurrence and severity of AEs and serious adverse events (SAEs), including pre-specified respiratory and cardiovascular deteriorations.
Part 2: All-cause mortality
时间窗: Within 28 days from randomisation
All deaths recorded on study
Part 2: All-cause Mortality
时间窗: Within 28 days from randomisation
All deaths recorded on study
次要结局
- Part 2: Time to Extubation(Up to 28 days from randomisation)
- Part 2: Number of ventilator free days(Up to 28 days from randomisation)
- Part 2: Duration of stay in ICU(Up to 28 days from randomisation)
- Part 2: Duration of stay in hospital(Up to 28 days from randomisation)
- Part 2: Change in IFNβ levels from baseline(Up to 14 days from randomisation)
- Part 2: No organ support(At 28 days from randomisation and at 28 days post final dose)
- Part 2: All Cause Mortality(Within 28 days post final dose)
- Part 2: AE and SAE severity(Up to 42 days from randomisation)
- Part 2: Change in mSOFA from baseline(Up to 14 days)
- Part 2: Change in OSCI from baseline(Up to 28 days from randomisation)
- Part 2: Time to first negative virus test(Up to 14 days from randomisation)
- Part 2: AE and SAE Severity(Up to 42 days from randomisation)
- Part 2: Change in mSOFA From Baseline(Up to 14 days)
- Part 2: Number of Ventilator Free Days(Up to 28 days from randomisation)
- Part 2: Duration of Stay in ICU(Up to 28 days from randomisation)
- Part 2: Duration of Stay in Hospital(Up to 28 days from randomisation)
- Part 2: Change in OSCI From Baseline(Up to 28 days from randomisation)
- Part 2: Time to First Negative Virus Test(Up to 14 days from randomisation)
- Part 2: Change in IFNβ Levels From Baseline(Up to 14 days from randomisation)
- Part 2: No Organ Support(At 28 days from randomisation and at 28 days post final dose)
研究者
研究点 (77)
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