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
|
|
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
|
|
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
|
|
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. |