Clinical trial NCT04522466: Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients
Official title: Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sars-CoV2
Keywords: SARS-CoV-2
Hydroxychloroquine
COVID-19
Intensive care unit
Pharmacokinetics
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: CHU Saint-Etienne - Laboratoire de Pharmacologie - Toxicologie - Gaz du sang
First posted: 2020-08-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics of hydroxychloroquine (HCQ)
timeFrame: Up to day 21
Secondary outcomes:
measure: Correlation between hydroxychloroquine (HCQ) concentration and cardiac toxicity (QT interval)
timeFrame: Up to day 21
measure: Correlation between Pharmacokinetic (concentration) and pharmacodynamic (viral load) of hydroxychloroquine (HCQ)
timeFrame: Day 1, Day 3, Day 5, Day 7, Day 14, Day 21
measure: Pharmacokinetic model
timeFrame: Up to day 21
Other outcomes:
Locations:
city: Montélimar
country: France
facility: Groupement Hospitalier des Portes de Province
city: Roanne
country: France
facility: Centre Hospitalier de Roanne
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
city: Saint-Étienne
country: France
facility: Clinique Mutualiste
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Sophie PERINEL, MD
role: PRINCIPAL_INVESTIGATOR
References: