Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients (PREAVIS)

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Terminated; Phase 3

Conditions: Sars-CoV2

Treatments: Drug: Hydroxychloroquine (HCQ)

Study type: Interventional

Funder types: Other

Identifiers

NCT04522466

20CH065

2020-001281-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Patients infected by SARS-CoV-2 treated by Hydroxychloroquine

Experimental group

Description:

Blood sample on patients infected by SARS-CoV-2 treated by Hydroxychloroquine

Treatment:

Drug: Hydroxychloroquine (HCQ)