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CTRI Number  CTRI/2021/01/030433 [Registered on: 13/01/2021] Trial Registered Prospectively
Last Modified On: 12/01/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A retrospective analysis to study the Effectiveness and Safety profile of Remdesivir therapy in patients who diagnosed with COVID-19 
Scientific Title of Study   Efficacy and Safety of Remdesivir in COVID-19: A retrospective analysis 
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 Shanbhag 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College 
Address  Department of Critical Care Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, 576104

Udupi
KARNATAKA
576104
India 
Phone  9901960496  
Fax    
Email  vishal.shanbhag@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Vishal Shanbhag 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College 
Address  Department of Critical Care Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, 576104

Udupi
KARNATAKA
576104
India 
Phone  9901960496  
Fax    
Email  vishal.shanbhag@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Girish Thunga 
Designation  Assistant Professor 
Affiliation  Manipal College of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9880151127  
Fax    
Email  girish.thunga@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College and Kasturba Hospital, Madhav Nagar, Manipal- 576104, Karnataka 
 
Primary Sponsor  
Name  Dr Vishal Shanbhag 
Address  Department of Critical Care Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Other [Principal Investigator] 
 
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 Shanbhag  Kasturba Medical College and Hospital   ICU1,ICU 2, ICU 3, MM7 First Floor, Trauma and Emergency Block, Department of Critical Care, Udupi, KARNATAKA
Udupi
KARNATAKA 		 9901960496

vishal.shanbhag@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  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  90.00 Year(s)
Gender  Both 
Details  All adults patients diagnosed with laboratory-confirmed SARS-CoV-2 infection from March 2020 to September 2020 in Kasturba Hospital Manipal irrespective of gender will be included 
 
ExclusionCriteria 
Details  Pediatric population 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mortality rate/death, Reversal of COVID-19/recovery, Duration of ICU or ventilation and/or Hospital stay, Negative RT-PCR, Improvement in Chest CT, Radiological parameters by CXR Brixia Score, and Lung Zone wise Brixia Score distribution  The outcomes will be measured at baseline, at 24 hours, 48 hours, 72 hours, and 5days post administration of remdesivir 
 
Secondary Outcome  
Outcome  TimePoints 
Safety measures such as Adverse events, Serious adverse events, Adverse drug reaction and Treatment discontinuation  The outcomes will be measured or monitored at baseline, at 24 hours, 48 hours, 72 hours, and 5days post administration of remdesivir 
 
Target Sample Size   Total Sample Size="1050"
Sample Size from India="1050" 
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)   18/01/2021 
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="1"
Months="6"
Days="5" 
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   Remdesivir is widely used among COVID-19 patients except for those patients with an estimated glomerular filtration rate of less than 30 mL/min. RCTs are evident on the effectiveness of remdesivir compared to placebo with respect to the shorter time to clinical improvement and duration of mechanical ventilation among those who are initiated with the treatment with 10 days of symptom onset, though it is not statistically significant. Moreover, observational studies reported that remdesivir was effective in improvement in chest CT scan, oxygen saturation, need for oxygenation, and discharge rate. Another RCT is evident for the better effectiveness of remdesivir than placebo in terms of recovery rate, recovery time with a better safety profile. However, no studies have been investigated the time of onset or initiation of remdesivir therapy in COVID-19. Hence we aimed to analyze the effectiveness and of early or late remdesivir therapy among the COVID-19 patients. 
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