Pharmacokinetic population analysis of antiviral drugs in the NOR SOLIDARITY study
The primary purpose of this study is to develop pharmacokinetic population models for the two antiviral drugs, remdesivir and hydroxychloroquine, which are tested for treatment of COVID-19 in the WHO NOR COVID 19 study. The main purpose of the population models will be to use them to individualize the dosage for future use in the treatment of COVID-19. In addition, the exploratory effect and side effects of COVID-19 treatment should be investigated in the measurement of viral decay, persistent inflammation and cardiac and renal function.
Patients included in one of the active treatment arms in the main study (WHO NOR COVID 19 study) will be recruited for this sub-study. Up to 7 additional blood tests will be taken during different dose intervals after the first dose and / or on treatment day 4 and / or day 8. The blood samples (whole blood, plasma and isolated blood cells) should be analyzed for the respective drug with which the patient is being treated; remdesivir or hydroxychloroquine.
Pharmacokinetic population modeling is the current gold standard for the analysis of pharmacokinetic data. They describe the pharmacokinetics of individuals in a population and how the variation is between individuals. It is possible to combine such models with efficacy measures and models to reveal the relationship between systemic drug exposure and efficacy. For example, in this study, we will try to create a model that links drug exposure and virus reduction rates. Pharmacokinetic population models may be used as a powerful tool to individualize the dosage to high-precision single patients so that patients achieve the desired systemic drug exposure, unlike equal dose to all or empirical dose adjustments based on measurement of blood concentrations just before the next dose.