Status:
TERMINATED
Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
CHU Saint-Etienne - Laboratoire de Pharmacologie - Toxicologie - Gaz du sang
Conditions:
Sars-CoV2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 stra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04522466
Start Date
April 3 2020
End Date
May 28 2020
Last Update
September 7 2020
Active Locations (4)
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1
Groupement Hospitalier des Portes de Province
Montélimar, France
2
Centre Hospitalier de Roanne
Roanne, France
3
CHU Saint-Etienne
Saint-Etienne, France
4
Clinique Mutualiste
Saint-Etienne, France