ISRCTN85436698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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 623
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36994453/ (added 31/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female, =18 years of age at the time of consent
- •2. Admitted to hospital due to the severity of their COVID-19
- •3. Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay. Patients who had 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 was 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 positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection
- •4. Require oxygen therapy via nasal prongs or mask (OSCI score of 4)
- •5. Provided informed consent
- •6. Female patients must be =1 year post-menopausal, surgically sterile, or using a highly effective method of contraception
排除标准
- •1. 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 or high-flow oxygen (OSCI score of 5)
- •3. Mechanical ventilation (continuous or intermittent CPAP or intubation) or admission to intensive care (OSCI score of =6)
- •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 (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
- •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-ß or to any of the excipients in the drug preparation
- •11. Females who are breastfeeding, lactating, pregnant or intending to become pregnant
- •12. Previous SARS-CoV-2 vaccination
研究者
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