The role of renal function in the pharmacokinetics and safety of remdesivir in COVID-19 patients

The role of renal function in the pharmacokinetics and safety of remdesivir in COVID-19 patients - Remdesivir in renal impairment

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51092

Enrollment

Registered

2021-01-18

Start date

2021-03-15

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

Coronavirus Disease 2019 COVID-19

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - diagnosed with COVID-19 by polymerase chain reaction (PCR) on exudate obtained by oral- nasopharyngeal swab - admitted to the Haga hospital (ward or ICU) - prescribed intravenous remdesivir - The subject has signed and dated a written informed consent.

Exclusion criteria

Exclusion criteria: - is expected to be transferred to another hospital during remdesivir therapy - The treating physician deems the subject unfit to participate in this study. - Pregnancy - Patients who choose to forego dialysis and prefer to be managed conservatively

Design outcomes

Primary

Measure	Time frame
- Remdesivir and metabolite (GS-44152) plasma 24-hours area under the curve - Remdesivir and metabolite half-life - Remdesivir and metabolite through concentration	—

Secondary

Measure	Time frame
Incidence of adverse events Clinical course	—

Countries

Netherlands

Outcome results