Pharmacokinetics of Dexamethasone in COVID-19 Obese Patients

NCT04996784 | Completed

• 1 other identifier: 2021-00034
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Keywords

Dexamethasone; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• AUC comparison

  The primary endpoint will be the AUC of DEX determined after a 6 mg oral dose at steady state.

  8 hours

Secondary Outcomes (3)

• PK parameters

  8 hours

• PK parameters

  8 hours

• PK parameters

  8 hours

Study Arms (2)

Normal weight

The patients (n=30) will be stratified into 2 groups based on their body mass Index (BMI).The normal weight group will contain 15 patients with a 18.5 ≤ BMI ≤ 25 kg/m2. Each group will be divided in two subgroups (female/ male)

Other: Capillary blood sampling

Obese

The patients (n=30) will be stratified into 2 groups based on their body mass Index (BMI). The obese group will contain 15 patients with a BMI ≥ 30 kg/m2. Each group will be divided in two subgroups (female/ male)

Other: Capillary blood sampling

Interventions

Capillary blood sampling OTHER

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).

Normal weight; Obese

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thirty COVID-19 hospitalized patients will be informed and included in the study after giving a written informed consent. The control group will include mainly normal weight patients (BMI 18.5- 25 kg/m2) receiving DEX.

You may qualify if:

• Male and female patients ≥ 18 years receiving DEX for COVID-19
• Stable dose of DEX for at least 24 hours
• BMI between 18.5 and 25 or ≥ 30 kg/m2
• Understanding of French orEnglish languages and ability to give a written inform consent

You may not qualify if:

• Medical history of cirrhosis (Child Pugh B and C) or/and nonalcoholic fatty liver disease.
• History of bariatric or other gastric surgery that may affect the drug absorption
• Patient already included in a clinical trial of an investigational drug
• Use of drugs that may affect CYP3A activity \* \*based on the 'drug interactions and cytochromes P450' table published by The Division of clinical Pharmacology and Toxicology \[15\], HUG and on the investigator's knowledge and on the drug interactions website from the University of Liverpool (https://www.covid19- druginteractions.org/checker).

Sponsors & Collaborators

• Jules Desmeules: lead

Study Sites (1)

University hospitals of Geneva

Geneva, 1205, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Clinical pharmacology,Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 9, 2021
• Study Start: February 2, 2021
• Primary Completion: February 9, 2021
• Study Completion: April 16, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)