EUCTR2020-001357-52-ES进行中（未招募）1 期
Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacyand Safety of Chemoprophylaxis With Hydroxychloroquine in Patients UnderBiological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2Infection. COVID-19
IDIVA0 个研究点目标入组 800 人开始时间: 2020年5月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
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) Patients between 18 and 75 years old at baseline
- •2) Subjects must be able and willing to give written informed consent
- •and to comply with the requirements of this study protocol
- •3) Patient in treatment with biological agents in a stable way, for a minimum period of 6 months, including treatment with Infliximab, etanercept, adalimumab, certolizumab, golimumab, rituximab, abatacept, tocilizumab, sarilumab, secukinumab, vedolizumab, natalizumab, ustekinumab, tofacitinib, baricitinib.
- •4) Diagnosis of inflammatory bowel disease, rheumatoid arthritis, seronegative spondyloarthritis or psoriasis for more than 6 months.
- •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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1) Previous infection with SARS-CoV-2.
- •2) Current treatment with hydroxychloroquine / chloroquine.
- •3) Previous or current treatment with tamoxifen or raloxifene.
- •4) Previous eye disease, especially maculopathy.
- •5) Known heart failure grade III-IV of the classification of the New York Heart Association).
- •6) Any type of cancer (except basal cell) in the last 5 years.
- •7) Pregnancy.
- •8) Refusal to give informed consent.
- •9) Evidence of any other unstable or clinically significant untreated immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric illness.
- •10) Instability or mental incompetence, so that the validity of the informed consent or the ability to complete the study is uncertain.
- •11) Positive antibodies to the human immunodeficiency virus.
- •12) Data on decompensated liver disease:
- •to. Aspartate aminotransferase (AST) and / or ALT> 10 x upper limit of normal (LSN).
- •b. Total bilirubin> 25 µmol / l (1.5 mg / dl).
- •c. International normalized index> 1.4.
- •d. Platelet count <100,000 / mm3.
- •13) Serum creatinine levels> 135 µmol / l (> 1.53 mg / dl) in men and> 110 µmol / l (> 1.24 mg / dl) in women.
- •14) Significant kidney disease, including nephrotic syndrome, chronic kidney disease (patients with markers of liver injury or estimated glomerular filtration rate [eGFR] of less than 60 ml / min / 1.73 m2). If an abnormal value is obtained at the first screening visit, the eGFR measurement may be repeated before randomization within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the planned randomization. Repeated abnormal eGFR (less than 60 ml / min / 1.73 m2) leads to exclusion from the study.
研究者
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