ISRCTN14241621已完成2 期
A randomised double-blind placebo-controlled trial to determine the safety and efficacy of inhaled SNG001 (IFNß-1a for nebulisation) for the treatment of patients with confirmed SARS-CoV-2 infection
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
研究概览
简要总结
2020 Results article in https://doi.org/10.1016/S2213-2600(20)30511-7 pilot results in hospitalised patients (added 26/11/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37669805/ at home setting results (added 30/01/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.1. Hospital setting: positive virus test for SARS-CoV-2 using RT-PCR, or positive point-of-care viral infection test in the presence of strong clinical suspicion of SARS-CoV-2 infection
- •1.2. Home setting: positive virus test for SARS-CoV-2 using a molecular assay e.g. RT-PCR in the presence of strong clinical suspicion of SARS-CoV-2 infection
- •2. Male or female, =18 years of age (hospital setting) or =50 years of age (home setting) at the time of consent
- •3.1. Hospital setting: patients admitted to hospital due to the severity of their COVID-19 disease OR
- •3.2. Home setting: non-hospitalised patients from high-risk groups, defined as =65-years of age, or =50 years of age and with any of the following risk factors:
- •3.2.1. Arterial hypertension
- •3.2.2. Cardiovascular disease
- •3.2.3. Diabetes mellitus
- •3.2.4. Chronic lung disease
- •3.2.5. Chronic kidney disease (eGFR <60 mL/min/1.73m2)
- •3.2.6. Chronic liver disease
- •3.2.7. Immunodeficiency due to a serious illness or medication
- •3.2.8. Cerebrovascular disease
- •3.2.9. Malignancy (except basal cell carcinoma) diagnosed in the last 5 years
- •3.2.10. Body Mass Index =30
- •who present with clinical symptoms consistent with COVID-19:
- •3.2.11. High temperature and/or
- •3.2.12. New, continuous cough
- •3.2.13. Loss or change to sense of smell and/or taste
- •4. Provide informed consent
- •5.1. Hospital setting: hospitalised female patients must be =1 year post-menopausal, surgically sterile, or using an acceptable method of contraception
- •5.2. Home setting: non-hospitalised female patients must be =1 year post-menopausal or surgically sterile
排除标准
- •1. > 24 hours after confirmation of SARS-CoV-2 infection by a molecular assay e.g. RT-PCR test (hospital and home settings) or >24 hours after a positive point-of-care viral infection test (hospital setting only). This criterion does not apply to patients in the hospital setting who had their positive RT-PCR test for SARS-CoV-2 performed prior to hospitalisation
- •2. >96 hours from onset of COVID-19 symptoms (cough and/or fever and/or loss or change to sense of smell and/or taste; home setting only)
- •3. 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
- •4. Current or previous participation in another clinical trial where the patient 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
- •5. Ventilated or in intensive care
- •6. Inability to use a nebuliser with a mouthpiece
- •7. History of hypersensitivity to natural or recombinant IFN-ß or to any of the excipients in the drug preparation
- •8. Females who are breast-feeding, lactating, pregnant or intending to become pregnant
研究者
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