EUCTR2020-002211-21-CZ进行中（未招募）1 期
A Phase II, randomised, double-blind, placebo-controlled clinical trial to assess the safety and efficacy of AZD1656 in diabetic patients hospitalised with suspected or confirmed COVID-19. The ARCADIA Trial - ARCADIA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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.
- •2. Aged 18 and older.
- •3. Have either T1DM or T2DM.
- •4. Hospitalised with suspected or confirmed novel coronavirus (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)) infection at time of enrolment, categorised as stage 3, 4 or 5 on the WHO Ordinal Scale for Clinical Improvement.
- •5. Blood glucose level at or above 4 mmol/L.
- •6. Able to take oral (tablet) formulation of medication.
- •7. Patient is able to provide written informed consent prior to initiation of any study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. In the opinion of the clinical team, progression to intubation or mechanical ventilation is imminent and inevitable, within the next 24 hours, irrespective of the provision of treatments.
- •2. Patients admitted with primary suspected or proven Mycoplasma pneumoniae, Chlamydia pneumoniae and bacterial pneumonia, who acquired COVID-19 while hospitalized.
- •3. Treatment with immunomodulators or anti-rejection drugs within the last 3 months.
- •4. Pregnant or breast feeding.
- •5. Men, and women of child-bearing potential, unwilling to use highly effective contraception during their participation in the trial and for 2 weeks after study completion.
- •6. Anticipated transfer to another hospital which is not a study site within 72 hours.
- •7. Known sensitivity to any of the study medication/placebo excipients.
- •8. Prior dosing with AZD1656 on a previous clinical trial.
- •9. Patients admitted as a result of and receiving immediate treatment for an acute asthmatic attack, acute myocardial infarction, acute cerebrovascular event.
- •10. Any known non-COVID-19, non-diabetes related, serious condition which, in the opinion of the clinical team, makes the patient unsuitable for the trial.
- •11. Known history of drug or alcohol abuse within previous 12 months of screening.
- •12. Known history of HIV, hepatitis C or unresolved hepatitis B or severe liver disease.
- •13. Current or planned use of gemfibrozil or any other strong inhibitors of CYP2C8.
- •14. Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product (IMP) containing small molecule treatment(s) within 30
- •days or 5 half-lives (whichever is longer) prior to enrolment into this study, or containing biological treatment(s) within 3 months prior to entry into this study.
研究者
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