Pharmacokinetics of sulfobutylether-β-cyclodextrin (SBECD) and Remdesivir in patientswith severe COVID19 and kidney disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- disease.
研究概览
简要总结
Remdesivir is a nucleotide analog which is being used in treatment of severe COVID-19. Remdesivir,
its active metabolite (GS-441524), and its vehicle - sulfobutylether-β-cyclodextrin (SBECD) are all
renally eliminated. There is lack of data of pharmacokinetics of Remdesivir and its vehicle -
sulfobutylether-β-cyclodextrin (SBECD) in patients with kidney disease. The aim of this study is to
evaluate the pharmacokinetics of Remdesivir, GS-441524, and SBECD in adult patients with severe
covid19 and kidney disease. This will be a prospective, open label study involving patients with
severe covid19 with kidney disease admitted at KEM hospital. We intend to include 12 patients with
end stage kidney failure on maintenance hemodialysis, 12 patients with acute kidney injury, and 12
kidney transplant recipients. Thus, total 36 patients will be included in this study. Blood samples
(5ml venous blood) and urine samples (10ml) will be collected for pharmacokinetic study. If patient
is on hemodialysis then dialysate samples, pre and post dialysis samples will also be collected. These
samples will undergo viral inactivation at the department of microbiology, KEM hospital in biosafety
level -2 cabinet. They will then be transferred to IIT Bombay in conditioned cartridge for
pharmacokinetic studies. Results of the pharmacokinetic studies will be correlated with the drug
effects and adverse effects in the patient. Our results may support the safety of Remdesivir in
patients with kidney disease, which is not established till date.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with severe COVID19 and kidney disease [any one of the following – end stage kidney disease OR acute kidney injury OR kidney transplant recipients with acute graft dysfuntion.
- •Patients in whom the treating physician decides to start Remdesivir as a part of standard care.
- •Willing to give written, informed consent.
- •Participants of either gender
- •Age >18 years.
排除标准
- •Patients with presumed or suspected diagnosis of COVID19
- •Patients with pregnancy
- •Patients with underlying liver disease [AST/ALT elevations > 5 times the upper limit of normal]
- •Patients with any known allergy of reaction to Remdesivir.
- •Patients requiring daily or more frequent dialysis sessions.
- •Patients in the AKI or transplant catergory who require dialysis.
结局指标
主要结局
disease.
时间窗: 1 YEAR
To evaluate the pharmacokinetics of SBECD in adult patients with severe covid19 and kidney
时间窗: 1 YEAR
次要结局
- To evaluate the pharmacokinetics of Remdesivir in adult patients with severe covid19 and(kidney disease)