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Hydroxychloroquine for the Treatment of SARS-CoV2 (COVID 19) : Pharmacokinetic Study (CHLORO-VID)

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ClinicalTrials.gov Identifier: NCT04625218
Recruitment Status : Suspended (Hydroxychloroquine is not yet used for the Treatment of SARS-CoV2 (COVID 19))
First Posted : November 12, 2020
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief Summary:
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).

Condition or disease
COVID-19 Pneumonia

Detailed Description:

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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Hydroxychloroquine for the Treatment of SARS-CoV2 (COVID 19) in the Critically Ill Patient: Pharmacokinetic Study. (CHLORO-VID)
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. residual plasma concentration [ Time Frame: Day 3 ]
    residual plasma concentration measured before re-administration of the treatment

  2. residual plasma concentration [ Time Frame: Day 5 ]
    residual plasma concentration measured before re-administration of the treatment

  3. residual plasma concentration [ Time Frame: Day 7 ]
    residual plasma concentration measured before re-administration of the treatment

  4. residual plasma concentration [ Time Frame: Day 9 ]
    residual plasma concentration measured before re-administration of the treatment


Secondary Outcome Measures :
  1. The number of days without artificial ventilation [ Time Frame: Day 28 ]
    number of days without artificial ventilation

  2. The length of hospital stay in intensive care [ Time Frame: Day 28 ]
    The length of hospital stay in intensive care measured in days number

  3. Survival [ Time Frame: Day 28 ]
    Statu alive or death

  4. Viral replication in the control bronchoalveolar lavage fluid on Day 7 [ Time Frame: Day 7 ]
    Viral replication on Day 7 measured by biological analysis of the bronchoalveolar lavage fluid

  5. Viral replication in the control bronchoalveolar lavage fluid on Day 14 [ Time Frame: Day 14 ]
    Viral replication on Day 14 measured by biological analysis of the bronchoalveolar lavage fluid


Biospecimen Retention:   Samples Without DNA
Blood samples from D1 to Day 9 of the hydroxychloroquine treatment

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in intensive care
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625218


Locations
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France
University Hospital of Toulouse
Toulouse, France
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Stéphanie RUIZ, PH University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04625218    
Other Study ID Numbers: RC31/20/0155
2020-A01094-35 ( Other Identifier: IDRCB )
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
SARS-CoV-2
hydroxychloroquine
pharmacokinetics
bronchoalveolar lavage fluid
Intensive Care Unit
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases