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

Phase 1

• Conditions: covid-19; MedDRA version: 20.0Level: LLTClassification code 10070267Term: SARS virus test positiveSystem Organ Class: 100000004848; MedDRA version: 21.1Level: PTClassification code 10022519Term: Intensive careSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001281-11-FR
• Lead Sponsor: CHU de Saint Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-26
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>- To describe the pharmacokinetic (concentration) and pharmacodynamic (viral load) relationship of hydroxychloroquine in resuscitation patients infected with SARS-CoV-2.<br>- 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 Outcome Measures

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