CTRI/2021/04/032791已完成3 期
A randomized, double-blind, placebo-controlled, Phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalized due to moderate COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 610
- 试验地点
- 15
- 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 hospitalized patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Admitted to hospital due to the severity of their COVID-19 2) 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 3) Require oxygen therapy via nasal prongs or mask (WHO OSCI score of 4) 4) Provided informed consent 5) Female patients must be greater than or equals to 1 year post-menopausal, surgically sterile, or using a protocol defined highly effective method of contraception 6) 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-beta (IFN-beta 1a)/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-beta1a/matching placebo to prevent pregnancy 7) 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 less than 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 greater than or equals to 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 enroll 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 2) Non-invasive ventilation (CPAP/BiPAP) or high-flow nasal oxygen.
- •therapy (WHO OSCI score of 5) 3) Endotracheal intubation and invasive mechanical ventilation (HO OSCI score of ≥6)) or admission to intensive care 4) Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay 5) 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 6) Participation in previous clinical trials of SNG001 7) 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 8) Inability to use a nebuliser with a mouthpiece 9) Inability to comply with the requirements for storage conditions of study medication in the home setting 10) History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation 11) Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
结局指标
主要结局
Time to hospital discharge
时间窗: Day 1 until Day 28 | Day 1 until Day 28
Time to recovery
时间窗: Day 1 until Day 28 | Day 1 until Day 28
次要结局
- Progression to severe disease or death(Day 1 until Day 35)
- Progression to intubation or death(Day 1 until Day 35)
- Death within 35 days of first dose(Day 1 until Day 35)
- Recovery as analysed at Days 7, 14, 21 and 28(Days 7, 14, 21 and 28)
- Hospital discharge by days 7, 14, 21 and 28(Days 7, 14, 21 and 28)
- Number of patients with improvement based on entire WHO OSCI score by days 7, 14, 21 and 28(Days 7, 14, 21 and 28)
- Change in total score according to the breathlessness, cough and sputum scale (BCSS) and disaggregated breathlessness and cough scores(Day 1 until Day 28 and then on Day 60 and Day 90)
- Changes in National Early Warning Score (NEWS2) during the hospitalisation period(Day 1 until Day 28)
- Number of patients with presence of COVID-19 symptoms based on daily assessment(Day 1 until Day 28)
- Number of patients with limitations of usual activities based on daily assessment(Day 1 until Day 28)
- 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; Day 1 until Day 35 (mobility, self care and usual activities dimension))
- Number of patients with long-COVID-19 symptoms based on General Anxiety Disorder 7 Questionnaire (GAD-7)(Day 15, Day 28, Day 60 and Day 90)
- Number of patients with long-COVID-19 symptoms based on FACIT Fatigue Scale (Version 4)(Day 15, Day 28, Day 60 and Day 90)
- Number of patients with long-COVID-19 symptoms based on Patient Health Questionnaire-9 (PHQ-9)(Day 15, Day 28, Day 60 and Day 90)
- Number of patients with long-COVID-19 symptoms based on Brief Pain Inventory (Short Form)(Day 15, Day 28, Day 60 and Day 90)
- Safety and tolerability vital signs, AEs concomitant medications, and immunogenicity(Day 1 until Day 28)
研究者
研究点 (15)
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