Evaluation of the concentration/viral effect relationship of hydroxychloroquine in COVID-19 patients in the intensive care unit..

Evaluation of the concentration/viral effect relationship of hydroxychloroquine in COVID-19 patients in the intensive care unit.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001281-11-FR

Enrollment

Registered

2020-03-26

Start date

2020-03-30

Completion date

Unknown

Last updated

2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

covid-19 MedDRA version: 20.0 Level: LLT Classification code 10070267 Term: SARS virus test positive System Organ Class: 100000004848 MedDRA version: 21.1 Level: PT Classification code 10022519 Term: Intensive care System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Plaquenil Product Name: Sulfate d'hydroxychloroquine Pharmaceutical Form: Coated tablet CAS Number: 747-36-4 Other descriptive name: HYDROXYCHLOROQUINE SULFATE Concentration unit: mg milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients hospitalized in the intensive care unit infected with SARS-CoV-2, for whom a diagnosis of respiratory SARS-CoV-2 infection was made by nasopharyngeal swab or deep respiratory sampling. - Patient receiving Hydroxychloroquine treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: to describe the pharmacokinetics of hydroxychloroquine in resuscitation patients infected with SARS-CoV-2.;Secondary Objective: - Describe the relationship between HCQ concentration and cardiac toxicity. - To describe the pharmacokinetic (concentration) and pharmacodynamic (viral load) relationship of hydroxychloroquine in resuscitation patients infected with SARS-CoV-2. - To define the best modalities of administration of hydroxychloroquine in resuscitation patients infected with SARS-CoV-2 based on the PK/PD relationship.;Primary end point(s): determination of the blood concentration of hydroxychloroquine by liquid chromatography coupled with mass spectrometry.;Timepoint(s) of evaluation of this end point: daily for 10 days	—

Measure

Time frame

Main Objective: to describe the pharmacokinetics of hydroxychloroquine in resuscitation patients infected with SARS-CoV-2.;Secondary Objective: - Describe the relationship between HCQ concentration and cardiac toxicity. - To describe the pharmacokinetic (concentration) and pharmacodynamic (viral load) relationship of hydroxychloroquine in resuscitation patients infected with SARS-CoV-2. - To define the best modalities of administration of hydroxychloroquine in resuscitation patients infected with SARS-CoV-2 based on the PK/PD relationship.;Primary end point(s): determination of the blood concentration of hydroxychloroquine by liquid chromatography coupled with mass spectrometry.;Timepoint(s) of evaluation of this end point: daily for 10 days

—

Secondary

Measure	Time frame
Secondary end point(s): - QT measurement by ECG monitoring - Viral load measurement by SARS-Cov-2 specific RT PCR - Simulations from the PK/PD model;Timepoint(s) of evaluation of this end point: daily for 10 days	—

Countries

France

Contacts

Public Contactproject manager

URCIP- CHU Saint Etienne

carine.labruyere@chu-st-etienne.fr33(0)477120469

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026