The role of renal function in the pharmacokinetics and safety of remdesivir in COVID-19 patients
Phase 4
Completed
- Conditions
- Coronavirus Disease 2019COVID-1910047438
- Registration Number
- NL-OMON51092
- Lead Sponsor
- HagaZiekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
- 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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Remdesivir and metabolite (GS-44152) plasma 24-hours area under the curve<br /><br>- Remdesivir and metabolite half-life<br /><br>- Remdesivir and metabolite through concentration</p><br>
- Secondary Outcome Measures
Name Time Method <p>Incidence of adverse events<br /><br>Clinical course </p><br>