NCT04732949已完成3 期
A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Determine the Efficacy and Safety of Inhaled SNG001 for the Treatment of Patients Hospitalised Due to Moderate COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 623
- 试验地点
- 112
- 主要终点
- Time to Hospital Discharge
研究概览
简要总结
The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.
详细描述
Eligible patients with SARS-CoV-2 infection confirmed by a positive virus test and who are hospitalised due to COVID-19 and require oxygen therapy, will be randomised in a 1:1 ratio to receive SNG001 two syringes or placebo two syringes. SNG001 or placebo will be administered via the Ultra nebuliser. Patients will receive a dose of SNG001 or placebo once a day for 14 days and will be followed up for up to 90 days after the first dose of study medication. Study data will be collected from patients daily, as per the study schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The study will be patient and investigator-blinded with regard to SNG001 or placebo but not the dose.
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
- •Admitted to hospital due to the severity of their COVID-19
- •Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay. Patients who had a positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test is performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection. Patients who had their first positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection
- •Require oxygen therapy via nasal prongs or mask (WHO OSCI score of 4)
- •Provided informed consent
- •Female patients must be ≥1 year post-menopausal, surgically sterile, or using a protocol defined highly effective method of contraception
- •Women of child bearing potential should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled interferon-β (IFN-β1a)/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in United Kingdom with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-β1a/matching placebo to prevent pregnancy
- •Women not of childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply: women <50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the postmenopausal range; women ≥50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment. If, in the setting of the pandemic, the use of an acceptable birth control method is not possible, the decision to enrol a woman of childbearing potential should be based on the benefit-risk for the patient, which should be discussed with the patient at the time of the informed consent.
排除标准
- •Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay
- •Non-invasive ventilation continuous positive airway pressure/bilevel positive airway pressure (CPAP/BiPAP) or high-flow nasal oxygen therapy (WHO OSCI score of 5)
- •Endotracheal intubation and invasive mechanical ventilation (WHO OSCI score of ≥6) or admission to intensive care
- •Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay
- •Any condition, including findings in the patients' medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation
- •Participation in previous clinical trials of SNG001
- •Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product 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
- •Inability to use a nebuliser with a mouthpiece
- •Inability to comply with the requirements for storage conditions of study medication in the home setting
- •History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation
- •Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
研究组 & 干预措施
SNG001
Active Comparator
SNG001 via inhalation using Ultra device, once a day for 14 days
干预措施: SNG001 (Drug)
Placebo
Placebo Comparator
Placebo via inhalation using Ultra device, once a day for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Hospital Discharge
时间窗: Day 28
The time to hospital discharge in patients with moderate COVID-19 after administration of SNG001 compared to placebo was evaluated.
Time to Recovery
时间窗: Day 28
Recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo by time to recovery was evaluated.
次要结局
- Number of Patients Who Were Intubated or Who Died(Until Day 35)
- Patient Health Questionnaire-9 (PHQ-9) Total Score(Day 15, Day 28, Day 60 and Day 90)
- Number of Patients Who Progressed to Severe Disease or Death(Until Day 35)
- Number of Patients Who Died Within 35 Days of First Dose(Until Day 35 of first dose)
- Cumulative Number of Patients Who Were Discharged From Hospital(Days 7, 14, 21 and 28)
- Cumulative Number of Patients With Recovery(Days 7, 14, 21 and 28)
- Improvement Based on Entire WHO OSCI Score(Until Day 35)
- Change From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS)(Baseline to Day 15)
- Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period(Day 1 until Day 28)
- Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores(Day 15, Day 28, Day 60 and Day 90)
- Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L)(Day 0, Day 7, Day 15, Day 28, Day 60 and Day 90)
- General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score(Day 15, Day 28, Day 60 and Day 90)
- Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score(Day 15, Day 28, Day 60 and Day 90)
- Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment(Day 1 until Day 90)
- Number of Patients With Limitations of Usual Activities Based on Daily Assessment(Day 1 until Day 35)
- Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From the day informed consent is obtained until 28 days after the last administration of the study medication (Day 90))
研究者
研究点 (112)
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