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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-03

Study Completion Date

2020-05-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Sars-CoV2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients infected by SARS-CoV-2 treated by Hydroxychloroquine

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

Group Type EXPERIMENTAL

Hydroxychloroquine (HCQ)

Intervention Type DRUG

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).

Interventions

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Hydroxychloroquine (HCQ)

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).

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No