Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001281-11 | EudraCT Number |
Not provided
Not provided
Stop of the study by competent authority (ANSM)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CHU Saint-Etienne - Laboratoire de Pharmacologie - Toxicologie - Gaz du sang | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients infected by SARS-CoV-2 treated by Hydroxychloroquine | Experimental | Blood sample on patients infected by SARS-CoV-2 treated by Hydroxychloroquine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine (HCQ) | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of hydroxychloroquine (HCQ) | measured blood concentration by blood sample results. | Up to day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between hydroxychloroquine (HCQ) concentration and cardiac toxicity (QT interval) | measured by blood sample and electrocardiogram results. | Up to day 21 |
| Correlation between Pharmacokinetic (concentration) and pharmacodynamic (viral load) of hydroxychloroquine (HCQ) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sophie PERINEL, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupement Hospitalier des Portes de Province | Montélimar | France | ||||
| Centre Hospitalier de Roanne |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
measured by blood sample |
| Day 1, Day 3, Day 5, Day 7, Day 14, Day 21 |
| Pharmacokinetic model | Pharmacokinetic (area under the curve) analysis will be performed using a population approach with a non-linear mixed effects model. | Up to day 21 |
| Roanne |
| France |
| CHU Saint-Etienne | Saint-Etienne | France |
| Clinique Mutualiste | Saint-Etienne | France |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |