COVID-19 Pneumonia Clinical Trial
Official title:
Hydroxychloroquine for the Treatment of SARS-CoV2 (COVID 19) in the Critically Ill Patient: Pharmacokinetic Study. (CHLORO-VID)
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT04901676 -
Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia
|
Phase 3 | |
Not yet recruiting |
NCT04534478 -
Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19
|
Phase 4 | |
Active, not recruiting |
NCT05002517 -
Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab
|
Phase 3 | |
Completed |
NCT05008393 -
Efficacy of PJS-539 for Adult Patients With COVID-19.
|
Phase 2 | |
Completed |
NCT04569877 -
GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia
|
Phase 2 | |
Not yet recruiting |
NCT05286255 -
Mesenchymal Stromal Cells for COVID-19 and Viral Pneumonias
|
Phase 1 | |
Completed |
NCT05035589 -
The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia
|
||
Recruiting |
NCT06113432 -
CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study
|
N/A | |
Recruiting |
NCT05042063 -
Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
|
||
Recruiting |
NCT04615429 -
Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19
|
Phase 2 | |
Completed |
NCT05047653 -
RALE Versus CORADS/CT-Severity Score in COVID-19
|
||
Active, not recruiting |
NCT05047016 -
Study to Evaluate the Dynamic Consent Model Based on the Blockchain-based Clinical Trial Platform METORY
|
N/A | |
Active, not recruiting |
NCT05033847 -
Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
|
Phase 2 | |
Recruiting |
NCT06113757 -
Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease
|
N/A | |
Completed |
NCT05504655 -
N-Acetylcysteine as an Adjuvant Therapy in Critically Ill COVID-19 Patients:
|
||
Active, not recruiting |
NCT05035524 -
A Randomized Controlled Trial to Investigate The Role of Adjuvant Inhalable Sodium Bicarbonate Solution 8.4% in Treatment of COVID-19
|
N/A | |
Completed |
NCT05065879 -
Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes
|
Phase 4 | |
Withdrawn |
NCT04390217 -
LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia
|
Phase 2 | |
Withdrawn |
NCT04460105 -
Lanadelumab in Participants Hospitalized With COVID-19 Pneumonia
|
Phase 1 | |
Suspended |
NCT04901689 -
Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation
|
Phase 3 |