COVID-19 Pneumonia Clinical Trial
— CHLORO-VIDOfficial title:
Hydroxychloroquine for the Treatment of SARS-CoV2 (COVID 19) in the Critically Ill Patient: Pharmacokinetic Study. (CHLORO-VID)
Verified date | October 2023 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient = 18 years old, - Hospitalized in intensive care, intubated and ventilated - With COVID-19 pneumonia confirmed by Rt-PCR, - Having as specific treatment hydroxychloroquine, whatever the dosage regimen - Having had the monitoring of the residual concentrations carried out by the Pharmacokinetics and Toxicology Laboratory of the Federative Institute of Biology of the Toulouse University Hospital the clinical Pharmacology and Toxicology laboratory of the Toulouse University Hospital - Person affiliated to a social security scheme or equivalent Exclusion Criteria: - Minor patients - Patients refusing to participate in the study - Person participating in another research including an exclusion period still in progress. - Contraindications to hydroxychloroquine: pre-existing retinopathy, known hypersensitivity to 4-aminoquinolines, hemolytic anemia, porphyria, G6PD deficiency, myasthenia gravis, association with citalopram, escitalopram, hydroxyzine, domperidone and piperaquine - Patients undergoing treatment with medicines known to prolong the QT interval or likely to induce a cardiac arrhythmia such as for example anti-arrhythmics of class IA and III, tricyclic antidepressants and certain anti-infectives (in particular antibiotics of the family of macrolides and fluoroquinolones as well as trimethoprim-sulfamethoxazole). - Pregnant or breastfeeding women |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | residual plasma concentration | residual plasma concentration measured before re-administration of the treatment | Day 3 | |
Primary | residual plasma concentration | residual plasma concentration measured before re-administration of the treatment | Day 5 | |
Primary | residual plasma concentration | residual plasma concentration measured before re-administration of the treatment | Day 7 | |
Primary | residual plasma concentration | residual plasma concentration measured before re-administration of the treatment | Day 9 | |
Secondary | The number of days without artificial ventilation | number of days without artificial ventilation | Day 28 | |
Secondary | The length of hospital stay in intensive care | The length of hospital stay in intensive care measured in days number | Day 28 | |
Secondary | Survival | Statu alive or death | Day 28 | |
Secondary | 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 | Day 7 | |
Secondary | 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 | Day 14 |
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