safety of Remdesivir use in patients with acute or chronic kidney disease and covid 19 infection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Remdesevir is safe in patients with acute or chronic kidney injury and covid 19 infection
研究概览
简要总结
COVID-19,caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), hasled to more than 50 million of infections and over 1 million deaths worldwide.Given the current, ongoing pandemic of COVID-19, there is a need to identifysafe and effective treatment options among so many available drugs. Remdesivir (GS-5734), a prodrug ofadenosine analogues, has been shown to have antiviral activity against severalRNA viruses, including MERS-CoV ,Ebola virus and SARS-CoV-2..On May1, 2020, after review of unpublished data from available clinical trials, theUS Food and Drug Administration (US FDA) issued an emergency use authorization (EUA)to permit the use of remdesivir, a nucleotide analogue that inhibits viralRNA-dependent RNA polymerase (RDRP), for treatment of severe coronavirus disease 2019 (COVID-19). Lateron October 22, 2020, FDA approved its use in adults andpediatric patients (12 years of age and older and weighing at least 40 kg) forthe treatment of COVID-19 requiring hospitalization.1Notably, patients with severe AKI and ESKD were excluded from this and allother remdesivir trials on the basis of eGFR cut-offs (either 50 or 30 ml/minper 1.73m2). Hence it isnot recommended in the group of patients where it required most just because oflack of data. But preliminary report suggests its use in these group ofpatients without its adverse effect on renal function.3. Based onthese data it has been used in these group of patients in our hospital as wellas all tertiary covid designated facilities after taking informed writtenconsent from patients’ relative as there is no other suitable alternativeexist. We want to analyse retrospectively its safety in these patients.
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
- •All covid positive (Rapid antigen test or RT PCR) patients admitted in shree Krishna hospital from March 2020 whose presenting creatinine is more than 1.4 mg/dl in Male or 1.2 mg/dl in Female or who are having oliguria /anuria (urine output less than 0.5 ml/kg/hour in first 24 hours -as per Standard KDIGO criteria) and who also received Remdesivir short or prolonged course during hospital stay will be included.
排除标准
- •Those Covid positive patients with renal dysfunction will be excluded from study if they do not complete the course of remdesevir suggested by clinician.
- •However, those patients who expired during treatment of remdesivir will be included in study and they will be analyzed separately.
结局指标
主要结局
Remdesevir is safe in patients with acute or chronic kidney injury and covid 19 infection
时间窗: 4 weeks
次要结局
- reduction in hospital stay and mortality in chronic kidney disease patients infected with covid 19 infection and severe lung involvement treated with remdesevir(8 weeks)
