This study is a prospective, observational, open, monocentric multisite, pharmacokinetic study of hydroxychloroquine in critically ill patients. The aim of this study is to assess the pharmacokinetic behavior of hydroxychloroquine in COVID-19 critically ill patients treated with crushed hydroxychloroquine tablets (administered enterally using a nasogastric tube).
Based on the in vitro activity against SARS-CoV-2 and preliminary clinical data, hydroxychloroquine is currently used in the management of COVID-19 patients. In the meantime, the efficacy as well as the dosage of hydroxychloroquine is highly debated. Because of the severity of COVID-19 and the pharmacokinetics of hydroxychloroquine in systemic lupus erythematosus patients, a loading dose was rapidly included in the new hospital regimens to optimize drug distribution in tissues and more precisely in the lungs. Due to the lack of information on the plasma/blood concentrations required to induce a virological/clinical effect, plasma/blood concentration is monitored in many European countries for patients whether or not they are included in clinical research protocols. This problem of relationship between efficacy and exposure is important in the critically ill patient because both the bioavailability and the variability of the pharmacokinetic parameters are potentially responsible for variations in concentrations. This study is a prospective, observational, open, multisite, pharmacokinetics study of hydroxychloroquine in critically ill patients. There is no supplemental intervention or additional samples compared to the standard care of these patients in our teaching hospital. The total duration of the study is that of the duration of hospitalization in intensive care. The duration of the pharmacokinetic study is 9 days, starting on D1 of the treatment with hydroxychloroquine, and ending with the last recommended residual plasma control. The total duration of treatment with hydroxychloroquine is 10 days, as recommended by the High Council of Public Health in its opinion of March 23, 2020.
Study Type
OBSERVATIONAL
University Hospital of Toulouse
Toulouse, France
residual plasma concentration
residual plasma concentration measured before re-administration of the treatment
Time frame: Day 3
residual plasma concentration
residual plasma concentration measured before re-administration of the treatment
Time frame: Day 5
residual plasma concentration
residual plasma concentration measured before re-administration of the treatment
Time frame: Day 7
residual plasma concentration
residual plasma concentration measured before re-administration of the treatment
Time frame: Day 9
The number of days without artificial ventilation
number of days without artificial ventilation
Time frame: Day 28
The length of hospital stay in intensive care
The length of hospital stay in intensive care measured in days number
Time frame: Day 28
Survival
Statu alive or death
Time frame: Day 28
Viral replication in the control bronchoalveolar lavage fluid on Day 7
Viral replication on Day 7 measured by biological analysis of the bronchoalveolar lavage fluid
Time frame: Day 7
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Viral replication in the control bronchoalveolar lavage fluid on Day 14
Viral replication on Day 14 measured by biological analysis of the bronchoalveolar lavage fluid
Time frame: Day 14