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CTRI Number  CTRI/2020/12/030046 [Registered on: 28/12/2020] Trial Registered Prospectively
Last Modified On: 24/12/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   safety of remdesivir use in patients with impaired kidney function and covid 19 infection  
Scientific Title of Study   safety of Remdesivir use in patients with acute or chronic kidney disease and covid 19 infection 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrMaulin Shah 
Designation  Consultant Nephrologist 
Affiliation  Pramukhswami medical college,H M Patel centre for medical care and education 
Address  Privilege center,The Healing Tree,Shree Krishna Hospital,H M Patel centre for medical care and education,Karamsad,Anand
Dialysis centre,Privilege economy ward,Shree krishna hospital,H M Patel centre for medical care and education,Karamsad,Anand
Anand
GUJARAT
388325
India 
Phone  9904163277  
Fax    
Email  mauls39@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrMaulin Shah 
Designation  Consultant Nephrologist 
Affiliation  Pramukhswami medical college,H M Patel centre for medical care and education 
Address  Privilege center,The Healing Tree,Shree Krishna Hospital,H M Patel centre for medical care and education,Karamsad,Anand
Dialysis centre,Privilege economy ward,Shree krishna hospital,H M Patel centre for medical care and education,Karamsad,Anand

GUJARAT
388325
India 
Phone  9904163277  
Fax    
Email  mauls39@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrMaulin Shah 
Designation  Consultant Nephrologist 
Affiliation  Pramukhswami medical college,H M Patel centre for medical care and education 
Address  Privilege center,The Healing Tree,Shree Krishna Hospital,H M Patel centre for medical care and education,Karamsad,Anand
Dialysis centre,Privilege economy ward,Shree krishna hospital,H M Patel centre for medical care and education,Karamsad,Anand

GUJARAT
388325
India 
Phone  9904163277  
Fax    
Email  mauls39@gmail.com  
 
Source of Monetary or Material Support  
Dr.Maulin Shah ,privilege centre,The Healing tree, shree Krishna hospital,karamsad,Anand 
 
Primary Sponsor  
Name  DrMaulin Shah 
Address  Privilege centre,The Healing tree,Shree krishna hospital,H M Patel centre for medical care and education,Karamsad,Anand 
Type of Sponsor  Other [self] 
 
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 
DrMaulin Shah  Pramukhswami medical college  covid wards and covid ICU of shree krishna hospital and Pramukhswami medical college,Karamsad
Anand
GUJARAT 
9904163277

mauls39@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee,Bhaikaka University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N179||Acute kidney failure, unspecified, (2) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (3) 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 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. 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Remdesevir is safe in patients with acute or chronic kidney injury and covid 19 infection  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   31/12/2020 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

COVID-19, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has led 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 identify safe and effective treatment options among so many available   drugs. Remdesivir (GS-5734), a prodrug of adenosine analogues, has been shown to have antiviral activity against several RNA viruses, including MERS-CoV ,Ebola virus  and SARS-CoV-2..On May 1, 2020, after review of unpublished data from available clinical trials, the US Food and Drug Administration (US FDA) issued an emergency use authorization (EUA) to permit the use of remdesivir, a nucleotide analogue that inhibits viral RNA-dependent RNA polymerase (RDRP), for treatment of  severe coronavirus disease 2019 (COVID-19). Later on October 22, 2020, FDA approved its use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. 1Notably, patients with severe AKI and ESKD were excluded from this and all other remdesivir trials on the basis of eGFR cut-offs (either 50 or 30 ml/min per 1.73m2).  Hence   it is not recommended in the group of patients where it required most just because of lack of data. But preliminary report suggests its use in these group of patients without its adverse effect on renal function.3. Based on these data it has been used in these group of patients in our hospital as well as all tertiary covid designated facilities after taking informed written consent from patients’ relative as there is no other suitable alternative exist. We want to analyse retrospectively its safety  in these patients.

 
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