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

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ClinicalTrials.gov Identifier: NCT04522466
Recruitment Status : Terminated (Stop of the study by competent authority (ANSM))
First Posted : August 21, 2020
Last Update Posted : September 7, 2020
Sponsor:
Collaborator:
CHU Saint-Etienne - Laboratoire de Pharmacologie - Toxicologie - Gaz du sang
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.

Condition or disease Intervention/treatment Phase
Sars-CoV2 Drug: Hydroxychloroquine (HCQ) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients
Actual Study Start Date : April 3, 2020
Actual Primary Completion Date : May 28, 2020
Actual Study Completion Date : May 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients infected by SARS-CoV-2 treated by Hydroxychloroquine
Blood sample on patients infected by SARS-CoV-2 treated by Hydroxychloroquine
Drug: 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).





Primary Outcome Measures :
  1. Pharmacokinetics of hydroxychloroquine (HCQ) [ Time Frame: Up to day 21 ]
    measured blood concentration by blood sample results.


Secondary Outcome Measures :
  1. Correlation between hydroxychloroquine (HCQ) concentration and cardiac toxicity (QT interval) [ Time Frame: Up to day 21 ]
    measured by blood sample and electrocardiogram results.

  2. Correlation between Pharmacokinetic (concentration) and pharmacodynamic (viral load) of hydroxychloroquine (HCQ) [ Time Frame: Day 1, Day 3, Day 5, Day 7, Day 14, Day 21 ]
    measured by blood sample

  3. Pharmacokinetic model [ Time Frame: Up to day 21 ]
    Pharmacokinetic (area under the curve) analysis will be performed using a population approach with a non-linear mixed effects model.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522466


Locations
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France
Groupement Hospitalier des Portes de Province
Montélimar, France
Centre Hospitalier de Roanne
Roanne, France
CHU Saint-Etienne
Saint-Étienne, France
Clinique Mutualiste
Saint-Étienne, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
CHU Saint-Etienne - Laboratoire de Pharmacologie - Toxicologie - Gaz du sang
Investigators
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Principal Investigator: Sophie PERINEL, MD CHU Saint-Etienne
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04522466    
Other Study ID Numbers: 20CH065
2020-001281-11 ( EudraCT Number )
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
SARS-CoV-2
Hydroxychloroquine
COVID-19
Intensive care unit
Pharmacokinetics
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents