Study of Remdesivir metabolism in patients with COVID-19 and kidney disease.
- Conditions
- Health Condition 1: N17- Acute kidney failureHealth Condition 2: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 3: N186- End stage renal disease
- Registration Number
- CTRI/2021/05/033744
- Lead Sponsor
- Department of nephrology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients with severe COVID19 and kidney disease [any one of the following â?? 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
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the pharmacokinetics of SBECD in adult patients with severe covid19 and kidney <br/ ><br>disease.Timepoint: 1 YEAR
- Secondary Outcome Measures
Name Time Method To evaluate the pharmacokinetics of Remdesivir in adult patients with severe covid19 and <br/ ><br>kidney disease <br/ ><br>To correlate the levels of SBECD and Remdesivir with any adverse events seen after <br/ ><br>administration of Remdesivir.Timepoint: 1 YEAR