To determine the influence of renal function and renal replacement therapy on the pharmackinetics and safety of remdesivir in COVID-19 patients.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Remdesivir and metabolite (GS-44152) plasma 24-hours area under the curve
- Remdesivir and metabolite half-life
- Remdesivir and metabolite through concentration
Secondary outcome
Incidence of adverse events
Clinical course
Background summary
Though it is not contra-indicated, the SPC warns against the use of Veklury
(Remdesivir) in patients with an eGFR *30 ml/min as data upon benefit and risks
are lacking. However, based on preclinical data and data about the toxicity of
SBECD (an excipient in Veklury) it is reasonable to assume that a short course
of remdesivir, such as is prescribed for the treatment of coronavirus disease
2019 (COVID-19), is safe in patients with severely impaired renal function. Up
to date only limited pharmacokinetic and clinical data to confirm this
statement are available. The medical need and increased use of remdesivir in
the COVID-19 pandemic presents an opportunity to investigate the
pharmacokinetics and safety of remdesivir in these patients.
Study objective
To determine the influence of renal function and renal replacement therapy on
the pharmackinetics and safety of remdesivir in COVID-19 patients.
Study design
The study is an observational, prospective, cohort study. Initiation of
remdesivir is not a part of this protocol. The pharmacokinetics will be
compared between three groups. The first group consists of COVID-19 patients
without severely decreased renal function (eGFR > 30 ml/min), the second of
patients with severely reduced renal function (eGFR * 30 ml/min) and the third
of patients receiving renal replacement therapy. Blood samples to investigate
the pharmacokinetics will be drawn on day 1 and 5 (or the day after the final
gift). The safety profile of remdesivir will be studied during and after the
treatment with remdesivir by monitoring the occurrence of AEs.
Study burden and risks
The study is an observational non-interventional study with blood sampling on
the first and fifth day of therapy. The risks for patients due to extra blood
sampling is regarded negligible. To further reduce complications, sampling
procedures will be performed by health care professionals who are trained in
these procedures.
Els Borst-Eilersplein 275
Den Haag 2545AA
NL
Els Borst-Eilersplein 275
Den Haag 2545AA
NL
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75815.058.20 |