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Study of Remdesivir metabolism in patients with COVID-19 and kidney disease.

Pharmacokinetics of sulfobutylether-β-cyclodextrin (SBECD) and Remdesivir in patients with severe COVID19 and kidney disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/05/033744
Enrollment
36
Registered
2021-05-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N17- Acute kidney failure Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 3: N186- End stage renal disease

Interventions

Intervention1: 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

Sponsors

Department of nephrology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
To evaluate the pharmacokinetics of SBECD in adult patients with severe covid19 and kidney disease.Timepoint: 1 YEAR

Secondary

MeasureTime frame
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.Timepoint: 1 YEAR

Countries

India

Contacts

Public ContactDr Divya Bajpai

Department of Nephrology

divyaa24@gmail.com8454024014

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026