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CTRI Number  CTRI/2021/01/030385 [Registered on: 11/01/2021] Trial Registered Prospectively
Last Modified On: 09/01/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   To study whether Remdesivir (an antiviral, used for the treatment of COVID - 19) is effective in COVID 19 patients with respect to complications of the disease or death.  
Scientific Title of Study   To Study the impact of Remdesivir on complications and mortality of COVID 19 patients admitted in 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 Sneha S 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Medicine, Kasturba Medical College, MAHE, Manipal, Udupi district - 576104

Udupi
KARNATAKA
576104
India 
Phone  9741970110  
Fax    
Email  sneha.s@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sneha S 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Medicine, Kasturba Medical College, MAHE, Manipal, Udupi district - 576104

Udupi
KARNATAKA
576104
India 
Phone  9741970110  
Fax    
Email  sneha.s@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sneha S 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Medicine, Kasturba Medical College, MAHE, Manipal, Udupi district - 576104

Udupi
KARNATAKA
576104
India 
Phone  9741970110  
Fax    
Email  sneha.s@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical college and Hospital,MAHE,Manipal Udupi district, Karnataka - 576104 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Kasturba medical college, Manipal, Udupi district  
Type of Sponsor  Private 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 Sneha S  Kasturba Medical College and Kasturba Hospital Manipal  Department of Medicine KMC Manipal MAHE Manipal Udupi district
Udupi
KARNATAKA 		 9741970110

sneha.s@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  1. All patient admitted in Kasturba Hospital, Manipal with COVID-19 positive by RTPCR / RAT between April 2020 and October 2020
2. All patient categorized as moderate or severe COVID as per standard guidelines. 
 
ExclusionCriteria 
Details  1. Patients who have sepsis from other sources
2. Patients with underlying lung disease like COPD, ILD, destroyed lung which may contribute to their hypoxia .
3. Patients with malignancy and other causes of immune suppression.
4. Patients who are pregnant. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The impact of remdesivir on outcomes in these patients will be analyzed  On admission, during the hospital stay till discharge of the patient 
 
Secondary Outcome  
Outcome  TimePoints 
Comorbidities
Details of hospital stay
Need for Oxygen and mechanical ventilation 		 during the hospital stay on daily basis 
 
Target Sample Size   Total Sample Size="1066"
Sample Size from India="1066" 
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)   20/01/2021 
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="3"
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   The emergence of COVID 19 virus as a global pandemic has posed a serious health threat worldwide. This novel corona virus has no specific treatment and various drugs with other indications have been tried. Remdesivir, an antiviral has showed some invitro activity against SARS-CoV-2. The clinical effectiveness of this drug is yet to be proven, with varied results from different clinical trials. Hence, this study is being undertaken to look for the impact of Remdesivir in COVID 19 patients.

All patients who were admitted in KH during the specified period with moderate and severe COVID will be included in the study. Demographics of patients, their COVID status (moderate or severe), their comorbidities and details of hospital stay, including stay in ICU, need for oxygen, need for mechanical ventilation will be documented.

Details of the therapy they received for COVID -19, including remdesivir and day of administration ,along with other drugs given , and supportive care will be noted.

The number of days of hospital stay and ICU stay and the outcomes in the form of survival or death will be collected.

These details will be statistically analyzed

 
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