| CTRI Number |
CTRI/2021/05/033744 [Registered on: 24/05/2021] Trial Registered Prospectively |
| Last Modified On: |
21/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Remdesivir metabolism in patients with COVID-19 and kidney disease. |
|
Scientific Title of Study
|
Pharmacokinetics of sulfobutylether-β-cyclodextrin (SBECD) and Remdesivir in patients
with severe COVID19 and kidney disease. |
| 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 |
Department of Nephrology |
| Address |
Department of Nephrology Seth G S Medical
College and KEM Hospital Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167460362 |
| Fax |
|
| Email |
tukaramjamale@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Bajpai |
| Designation |
Associate Professor |
| Affiliation |
Department of Nephrology |
| Address |
Department of Nephrology Seth G S Medical
College and KEM Hospital Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8454024014 |
| Fax |
|
| Email |
divyaa24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Bajpai |
| Designation |
Associate Professor |
| Affiliation |
Department of Nephrology |
| Address |
Department of Nephrology Seth G S Medical
College and KEM Hospital Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8454024014 |
| Fax |
|
| Email |
divyaa24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of nephrology
Seth G S Medical
College and KEM Hospital Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Department of nephrology |
| Address |
Seth G S Medical
College & KEM Hospital Acharya Donde Marg Parel Mumbai 400 012 India |
| 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 G S Medical College and KEM Hospital |
Department of Nephrology,
Ward no 34A 3rd floor old building Mumbai 400012
Mumbai
MAHARASHTRA |
8454024014
divyaa24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N17||Acute kidney failure, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (3) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
remdesivir |
We will be checking pharmacokinetics of remdesivir. there is no comparator agent.
The dose is 200 mg on Day 1, followed by 100 mg for next 4 days.
The mode of administration is Intravenous |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with severe COVID19 and kidney disease [any one of the following – end stage kidney
disease OR acute kidney injury OR kidney transplant recipients with acute graft dysfuntion.
2. Patients in whom the treating physician decides to start Remdesivir as a part of standard care.
3. Willing to give written, informed consent.
4. Participants of either gender
5. Age >18 years |
|
| ExclusionCriteria |
| Details |
1. Patients with presumed or suspected diagnosis of COVID19
2. Patients with pregnancy
3. Patients with underlying liver disease [AST/ALT elevations > 5 times the upper limit of normal]
4. Patients with any known allergy of reaction to Remdesivir.
5. Patients requiring daily or more frequent dialysis sessions.
6. Patients in the AKI or transplant catergory who require dialysis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the pharmacokinetics of SBECD in adult patients with severe covid19 and kidney
disease. |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the pharmacokinetics of Remdesivir in adult patients with severe covid19 and
kidney disease
To correlate the levels of SBECD and Remdesivir with any adverse events seen after
administration of Remdesivir. |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/06/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Remdesivir is a nucleotide analog which is being used in treatment of severe COVID-19. Remdesivir, its active metabolite (GS-441524), and its vehicle - sulfobutylether-β-cyclodextrin (SBECD) are all renally eliminated. There is lack of data of pharmacokinetics of Remdesivir and its vehicle - sulfobutylether-β-cyclodextrin (SBECD) in patients with kidney disease. The aim of this study is to evaluate the pharmacokinetics of Remdesivir, GS-441524, and SBECD in adult patients with severe covid19 and kidney disease. This will be a prospective, open label study involving patients with severe covid19 with kidney disease admitted at KEM hospital. We intend to include 12 patients with end stage kidney failure on maintenance hemodialysis, 12 patients with acute kidney injury, and 12 kidney transplant recipients. Thus, total 36 patients will be included in this study. Blood samples (5ml venous blood) and urine samples (10ml) will be collected for pharmacokinetic study. If patient is on hemodialysis then dialysate samples, pre and post dialysis samples will also be collected. These samples will undergo viral inactivation at the department of microbiology, KEM hospital in biosafety level -2 cabinet. They will then be transferred to IIT Bombay in conditioned cartridge for pharmacokinetic studies. Results of the pharmacokinetic studies will be correlated with the drug effects and adverse effects in the patient. Our results may support the safety of Remdesivir in patients with kidney disease, which is not established till date. |