| CTRI Number |
CTRI/2020/06/026000 [Registered on: 21/06/2020] Trial Registered Prospectively |
| Last Modified On: |
15/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Clinical Observational |
| Study Design |
Other |
|
Public Title of Study
|
COVID-19 in kidney transplant recipient |
|
Scientific Title of Study
|
Clinical Profile, management and outcomes of COVID-19 in kidney transplant recipients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tukaram Jamale |
| Designation |
Professor and Head |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Nephrology
Seth GS Medical College and KEM Hospital. Ward 34A, old hospital building, 3rd floor, Acharya Donde Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167460362 |
| Fax |
|
| Email |
tukaramjamale@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tukaram Jamale |
| Designation |
Professor and Head |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Nephrology
Seth GS Medical College and KEM Hospital. Ward 34A, old hospital building, 3rd floor, Acharya Donde Marg, Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167460362 |
| Fax |
|
| Email |
tukaramjamale@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Bajpai |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Nephrology
Seth GS Medical College and KEM Hospital. Ward 34A, old hospital building, 3rd floor, Acharya Donde Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8454024014 |
| Fax |
|
| Email |
divyaa24@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Nephrology, Ward 34A, Old hospital building, 3rd floor, Acharya Donde Marg, Parel, Mumbai-12 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Divya Bajpai |
Seth GS Medical College and KEM Hospital |
Department of Nephrology
Ward 34A, Old hospital building, 3rd floor, KEM Hospital, Acharya Donde Marg, Parel, Mumbai-12
Mumbai
MAHARASHTRA |
8454024014
divyaa24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC)-III, Seth G.S.Medical college and KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) 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 |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Kidney transplant recipients admitted to KEMH with diagnosis of COVID-19 by
investigation (Positive swab test for COVID-19)
2. Age >18yrs
3. Both genders are to be included |
|
| ExclusionCriteria |
| Details |
1. Patients with incomplete medical records |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome of kidney transplant recipients with Covid-19 infection |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find clinical, laboratory imaging features and course of disease
2. To study the response to therapy
3. To find predictors and severity of disease in transplant recipients
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2020 |
| Date of Study Completion (India) |
30/06/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
In Indian or International Journals |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The worldwide spread of the Coronavirus disease 2019 (COVID-19) pandemic due to the novel SARS-CoV-2 virus, poses a significant challenge to the patients with chronic kidney disease. Especially renal transplant recipients are deemed to be more vulnerable, considering their state of immunosuppression. Solid organ transplant recipients may be at increased risk also as they have frequent contact with the health care system. Clinical features of COVID-19 among kidney recipients are not well documented but we know from our previous experience with infectious disease in this population that they can be dissimilar to those in nonimmunocompromised patients. Additional studies are required to determine the impact of specific immunosuppressive agents on the course of COVID-19 infection.Optimal management of COVID19 in kidney transplant recipients is not known and there is very scarce evidence about outcomes of COVID19 in kidney transplant recipients. We propose a retrospective observational study to evaluate the clinical profile, management and outcomes of COVID19 in kidney recipients. All recipients admitted to hospital with COVID19 will be enrolled in the study. Details of their demographics, presentation, investigations, treatment and outcome will be recorded from their files at the time of discharge or in an unfortunate event of death. There will be no extra investigation or cost for the purpose if the study. The results of this study will fill the lacunae in the knowledge of presentation, management and outcomes of this disease. It will help us in improving our understanding of behavior of COVID19 in kidney transplant recipients which will enable us to better manage the patients in future.
|