EUCTR2020-004743-83-BE进行中（未招募）1 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 - SPRINTER
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 610
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
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 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.
- •4. Require oxygen therapy via nasal prongs or mask (WHO 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. Acceptable highly effective methods of contraception include;
- •bilateral tubal occlusion
- •intrauterine device (provided coils are copper-banded)
- •levonorgestrel intrauterine system (e.g., Mirena™)
- •medroxyprogesterone injections (e.g., Depo-Provera™)
- •etonogestrel implants (e.g., Implanon™, Norplan™)
- •normal and low dose combined oral pills
- •norelgestromin/ ethinylestradiol transdermal system
- •intravaginal device (e.g., ethinylestradiol and etonogestrel), desogestrel (e.g., Cerazette™)
- •total sexual abstinence (defined as refraining from heterosexual intercourse)
- •vasectomised sexual partner.
- •Women of childbearing 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 IFN-ß1a/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in UK 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-ß1a/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 <50 years old would 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 would 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number o
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 (CPAP / BiPAP) or high-flow nasal oxygen therapy (WHO OSCI score of 5).
- •3. Endotracheal intubation and invasive mechanical ventilation (WHO 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 (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 breast-feeding, lactating, pregnant or intending to become pregnant.
研究者
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