ObesityCoDEXNCT04996784
Pharmacokinetics of Dexamethasone in COVID-19 Obese Patients
An observational study of Obesity, run by Jules Desmeules at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Capillary blood sampling
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Feb 2021to 16 Apr 2021
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Before starting the study, COVID-19 patients receiving dexamethasone as part of their hospital management and meeting the criteria of inclusion and non-exclusion will have an information session with an investigator as described above.
During the study session, capillary blood samples will be taken during a total of 8 hours, time starting just before DEX administration, and at the following times after the dose: time of the drug intake, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours. 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). After a 45-minute drying time at room temperature, dried blood samples (DBS) samples will be packed in sealable plastic bags containing a desiccant and stored at - 80°C until analysis. Drugs will be extracted from DBS using methanol. DEX quantification in capillary DBS will be performed using reverse-phase- HPLC coupled to tandem mass spectrometer (MS/MS). In addition to this, an EDTA tube (3 ml) of blood will be collected and preserved in the biobank (-80°C) and will be used whether further analysis should be performed on the samples. In this aim an authorization to reuse the samples will be requested from each patient during the consent signature.
- Conditions
- Obesity
- Being tested
- Capillary blood sampling
- Keywords
- Dexamethasone, Pharmacokinetics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary blood samplingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Capillary blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC comparison
The primary endpoint will be the AUC of DEX determined after a 6 mg oral dose at steady state.
Measured: 8 hours
Secondary outcomes (3)
PK parameters
Extrapolation from the AUC values of the Dexamethasone Clearance in the two groups
Measured: 8 hours
PK parameters
Extrapolation from the AUC values of the Dexamethasone Cmax in the two groups
Measured: 8 hours
PK parameters
Extrapolation from the AUC values of the Dexamethasone T1/2 in the two groups
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start2 Feb 2021
- Primary completion9 Feb 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Jules Desmeules
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jules Desmeules, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996784
- Sponsor's protocol ID
- 2021-00034
- Acronym
- CoDEX
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Dexamethasone in COVID-19 Obese Patients
- ClinicalTrials.gov ID
- NCT04996784
- Acronym / sponsor ID
- CoDEX / 2021-00034
- Conditions
- Obesity
- Keywords
- Dexamethasone, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jules DesmeulesUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Before starting the study, COVID-19 patients receiving dexamethasone as part of their hospital management and meeting the criteria of inclusion and non-exclusion will have an information session with an investigator as described above.
During the study session, capillary blood samples will be taken during a total of 8 hours, time starting just before DEX administration, and at the following times after the dose: time of the drug intake, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours. 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). After a 45-minute drying time at room temperature, dried blood samples (DBS) samples will be packed in sealable plastic bags containing a desiccant and stored at - 80°C until analysis. Drugs will be extracted from DBS using methanol. DEX quantification in capillary DBS will be performed using reverse-phase- HPLC coupled to tandem mass spectrometer (MS/MS). In addition to this, an EDTA tube (3 ml) of blood will be collected and preserved in the biobank (-80°C) and will be used whether further analysis should be performed on the samples. In this aim an authorization to reuse the samples will be requested from each patient during the consent signature.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | Other: Capillary blood samplingThe 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) |
| Obese | – | Other: Capillary blood samplingThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capillary blood samplingThe 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). | Other | Normal weight, Obese |
Primary outcome
AUC comparison
Time frame: 8 hours
The primary endpoint will be the AUC of DEX determined after a 6 mg oral dose at steady state.
3 secondary outcomes
PK parameters
Time frame: 8 hours
PK parameters
Time frame: 8 hours
PK parameters
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Jules Desmeules at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC comparison (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.