EUCTR2020-001442-19-ES进行中（未招募）1 期
Pilot, randomized, multicenter, open-label clinical trial of combined use of hydroxychloroquine, azithromycin, and tocilizumab for the treatment of SARS-CoV-2 infection (COVID-19) - TCOVID
INSTITUT DE RECERCA H. SANTA CREU I SANT PA0 个研究点目标入组 276 人开始时间: 2020年4月3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
- 276
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. Subject (or authorized legal representative) who can provide written informed consent before beginning any study procedure.
- •2. Understand and agree to abide by the study procedures.
- •3. Adult =18 years of age at the time of inclusion in the study.
- •4. Confirmation of SARS-CoV-2 infection by a microbiological test performed before randomization, no longer than 72 hours.
- •5. Gravity 3-4 according to the WHO 7-point ordinal scale:
- •- Severity 3. Hospitalized, which does not require supplemental oxygen
- •- Severity 4. Hospitalized, requiring supplemental oxygen
- •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 276
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. ALT / AST> 5 times the normal limit
- •2. Stage 4 chronic kidney disease (GFR <30) or requiring dialysis.
- •3. Presence of comorbidities that imply a poor prognosis (according to clinical judgment).
- •4. Advanced dementia.
- •5. Pregnancy or breastfeeding.
- •6. Forecast of transfer to another center in the 12 hours at the beginning of the study.
- •7. Allergy to study medication.
- •8. Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2.
- •9. Streptococcus pneumoniae antigenuria positive before study start.
- •10. Neutropenia <500 / mm3.
- •11. Plateletpenia <100,000 / mm3.
- •12. History of diverticulosis.
- •13. Ongoing skin infection (eg, pyodermitis).
- •14. Transplanted patient under immunosuppressive treatment.
- •15. Previous evidence of latent untreated tuberculosis.
研究者
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