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
|Condition or disease||Intervention/treatment||Phase|
|Sars-CoV2||Drug: Hydroxychloroquine (HCQ)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
- Pharmacokinetics of hydroxychloroquine (HCQ) [ Time Frame: Up to day 21 ]measured blood concentration by blood sample results.
- Correlation between hydroxychloroquine (HCQ) concentration and cardiac toxicity (QT interval) [ Time Frame: Up to day 21 ]measured by blood sample and electrocardiogram results.
- 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
- 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.
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
|Groupement Hospitalier des Portes de Province|
|Centre Hospitalier de Roanne|
|Principal Investigator:||Sophie PERINEL, MD||CHU Saint-Etienne|