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CTRI Number  CTRI/2021/01/030341 [Registered on: 08/01/2021] Trial Registered Prospectively
Last Modified On: 07/01/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The outcome of Remdesivir and Tocilizumab in COVID 19. 
Scientific Title of Study   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.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vishal A Gupta 
Designation  Associate professor and MICU Incharge  
Affiliation  Seth GSMC and KEM Hospital, Mumbai 
Address  Department of General Medicine Seth G S Medical college and KEM hospital, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  drvagupta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishal A Gupta 
Designation  Associate professor and MICU Incharge  
Affiliation  Seth GSMC and KEM Hospital, Mumbai 
Address  Department of General Medicine Seth G S Medical college and KEM hospital, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  drvagupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sushrut Ingawale 
Designation  Resident 
Affiliation  Seth GSMC and KEM Hospital, Mumbai 
Address  Department of General Medicine Seth G S Medical college and KEM hospital, Mumbai
1177 Krishna Clinic, Phulewadi Kolhapur, Maharashtra
Mumbai
MAHARASHTRA
400012
India 
Phone  9152730657  
Fax    
Email  sushrutingawale@gmail.com  
 
Source of Monetary or Material Support  
Seth G S Medical College and KEM Hospital, Mumbai 
 
Primary Sponsor  
Name  Seth G S Medical College and KEM Hospital Mumbai 
Address  Seth G S Medical College and KEM Hospital Mumbai, Acharya Donde Marg, Parel (East), Mumbai 400012 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vishal A Gupta  Seth G S Medical College and KEM Hospital, Mumbai  Department of Medicine, 2nd floor, Old building, near Gate no 2, Seth G S Medical College and KEM Hospital Mumbai, Acharya Donde Marg, Parel (East), Mumbai 400012
Mumbai
MAHARASHTRA 
9869136601

drvagupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee 3, Seth G. S. Medical College and KEM Hospital, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  1. Suspected COVID 19 patients.
2. Positive patients in category 1A to 2A
3. Pregnant/Lactating patients.
4. Mortality within 24 hours of admission. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)To assess the outcome of COVID 19 positive patients who have received Remdesivir or Tocilizumab or their combination.
2)To observe the clinical factors affecting the outcome.

 
1)1 month.
2)1 month. 
 
Secondary Outcome  
Outcome  TimePoints 
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. 
1 month 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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,

 
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