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Pharmacokinetics of Dexamethasone in COVID-19 Obese Patients

NCT04996784 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2021-08-09

No results posted yet for this study

Summary

In this regard, the present research project aims to compare dexamethasone PK in normal-weight versus obese patients treated for COVID-19.

This observational study will include patients hospitalized at HUG (Division of General Internal Medicine) with COVID-19 and treated with oral DEX. This study will include 2 groups of patients according to their body mass index (BMI) (normal weight with a BMI of 18.5-25.0 kg/m2; obese/ morbidly obese with a BMI ≥30). The primary outcome will be the assessment of the differential impact of weight on DEX PK. Finally, the data generated will be used to build a physiologically based PK (PBPK) model for DEX and in different sub-groups. The model will aim to predict the effect of BMI in virtual populations with different drugs and in different scenarios. This should allow prospective dose adjustment of DEX based on patient weight.

Conditions

Interventions

OTHER

Capillary blood sampling

The capillary blood sample will be obtained by pricking the fingertip using contact-activated lancet (BD Microtainer). A total of five blood drops (10 μL each) will be collected by a micropipette and will be dropped off on the blotting paper 903 S\&S (Whatman).

Sponsors & Collaborators

  • Jules Desmeules

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2021-02-09
Completion
2021-04-16

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04996784 on ClinicalTrials.gov