Sars-CoV2
Conditions
Keywords
SARS-CoV-2, Hydroxychloroquine, COVID-19, Intensive care unit, Pharmacokinetics
Brief summary
To date, no treatment has demonstrated clinical efficacy on COVID 19. However, several therapeutic strategies are being considered and are being evaluated in numerous clinical trials. Among these strategies, the use of hydroxychloroquine (HCQ) seems promising. There is very little information on how to precisely administer hydroxychloroquine to patients infected with SARS-CoV-2 in intensive care, which may be responsible for side effects, some of which are potentially serious. In addition, this treatment has a long half-life which increases the risk of accumulation and therefore toxicity. In view of the lack of knowledge on the pharmacokinetic / pharmacodynamic properties of hydroxychloroquine in intensive care patients infected with SARS-CoV-2, we propose to perform a prospective multicenter cohort study in order to collect the biological data necessary for this evaluation.
Interventions
Hydroxychloroquine (HCQ) will be administered as usual practice: dosage is adjusted to maintain a concentration between 1 and 2 mg/L. Measure pharmacokinetics and pharmacodynamics of Hydroxychloroquine (HCQ).
Sponsors
CHU Saint-Etienne - Laboratoire de Pharmacologie - Toxicologie - Gaz du sang
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients 18 years of age and older * Patients hospitalized in the intensive care unit infected with CoV-2-SARS for whom a diagnosis of respiratory CoV-2-SARS infection has been made by nasopharyngeal swab or deep respiratory sampling. * Patient receiving HCQ treatment as part of care or as part of a clinical trial. * Patient affiliated or entitled to a social security scheme
Exclusion criteria
* Hypersensitivity to the active substances or to any of the following excipients: lactose monohydrate, povidone, corn starch, magnesium stearate. * Retinopathies * Combination with citalopram, escitalopram, hydroxyzine, domperidone and piperazine due to increased risk of ventricular rhythm disturbances, including torsades de pointes. * Patient with known QT prolongation * Known deficit in G6PD * Pregnant woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of hydroxychloroquine (HCQ) | Up to day 21 | measured blood concentration by blood sample results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between hydroxychloroquine (HCQ) concentration and cardiac toxicity (QT interval) | Up to day 21 | measured by blood sample and electrocardiogram results. |
| Correlation between Pharmacokinetic (concentration) and pharmacodynamic (viral load) of hydroxychloroquine (HCQ) | Day 1, Day 3, Day 5, Day 7, Day 14, Day 21 | measured by blood sample |
| Pharmacokinetic model | Up to day 21 | Pharmacokinetic (area under the curve) analysis will be performed using a population approach with a non-linear mixed effects model. |
Countries
France
Outcome results
None listed