跳至主要内容
临床试验/CTRI/2021/01/030341
CTRI/2021/01/030341尚未招募不适用

To study the outcome of COVID 19 positive patients who have received Remdesivir or Tocilizumab or their combination during their treatment in a tertiary care hospital.

Seth G S Medical College and KEM Hospital Mumbai1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年1月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
试验地点
1
主要终点
1)To assess the outcome of COVID 19 positive patients who have received Remdesivir or Tocilizumab or their combination.

研究概览

简要总结

Novel Coronavirus (n COVID-19) infection is a pandemic that has affected the world and India continues to be one of the worst hit nations with more than 2 million cases till date. The course of the disease and outcome varies as per the existing co-morbidities and age of the patient. Various drugs have been proposed and used over time including Hydroxychloroquine, Lopinavir-Ritonavir, Convalescent plasma, Favipiravir/Remdesivir, Tocilizumab and so on. There are multiple ongoing studies around the world to come up with the best possible treatment. The data from Indian population on the outcome of treatment using these drugs is relatively scarce. Our study is to analyze the outcome of patients who have received these drugs at our institute. This will not only add to the literature but will also help us guide any future amendments in our institutional management protocols, if needed.

 The study will begin only after approval from the Institutional Ethics Committee. It is a Single-centered, retrospective, observational study. It is secondary analysis of data, hence no direct contact with patient. Therefore waiver of consent is granted.

Patients who are Laboratory confirmed COVID 19 adults (Age > 18 years) admitted in KEM Hospital of ICMR group 2B and onwards and received any of the following three drugs alone or in combination: Remdesivir, Tocilizumab will be included. Suspected COVID 19 patients, Positive patients in category 1A to 2A, Pregnant/Lactating patients and Mortality within 24 hours of admission will be excluded. Since Covid 19 is a novel disease with a limited data, sample size cannot be predicted, hence all patients satisfying the inclusion criteria will be included. Patients admitted between 1st April, 2020 and 30th September, 2020 and had an outcome will be included by complete enumeration.The sample size is estimated to be around 500 patients.

 Data on patient basic details, chronic medical histories, symptoms, vital signs at admission, laboratory values on admission, timing between admission and intubation, timing between admission and mortality/discharge, duration of ventilation, mode of ventilation and other treatment details whatever available, will be studied retrospectively. Outcome measures include: Mortality or Discharge. Duration of Hospitalization, Duration of Oxygen therapy and Duration to bring a change in the score of ordinal scale of clinical improvement given by WHO. The results will be analyzed in SPSS software. Data will be looked to check for Normal distribution or not and accordingly, necessary tests will be applied. Demographic data (eg- Age, Sex, etc) will be analyzed using descriptive statistics. Categorical data (eg- Outcome: Discharge/Death) will be analyzed using non-parametric tests. Continuous data (eg- duration/time) will be analyzed using parametric tests. The data will be analyzed on a personalized computer which is password protected and also an antivirus. Only the principal investigator and Co-investigator will have access to the data.

Our study will not only add to the literature but will also help us guide any future amendments in our institutional management protocols, if needed.

Results & analyses will be shared at the end of the study,

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Laboratory confirmed COVID 19 adults (Age > 18 years) admitted in KEM Hospital.
  • 2.Patients in ICMR group 2B and onwards.
  • 3.Received any of the following drugs alone or in combination: Remdesivir, Tocilizumab.

排除标准

  • Suspected COVID 19 patients.
  • Positive patients in category 1A to 2A
  • Pregnant/Lactating patients.
  • Mortality within 24 hours of admission.

结局指标

主要结局

1)To assess the outcome of COVID 19 positive patients who have received Remdesivir or Tocilizumab or their combination.

时间窗: 1)1 month. | 2)1 month.

2)To observe the clinical factors affecting the outcome.

时间窗: 1)1 month. | 2)1 month.

次要结局

  • To study the duration of hospitalization, duration of oxygen therapy and duration required to bring about the change in the score of Ordinal scale for Clinical Improvement given by World Health Organization (WHO), until the final outcome.(To observe for any adverse events, adverse drug reactions or any complications related to the standard treatment.)

研究者

发起方
Seth G S Medical College and KEM Hospital Mumbai
申办方类型
Government medical college

研究点 (1)

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