Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT04625218
Status:
WITHDRAWN
Last Update Posted:
2023-10-16
First Post:
2020-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hydroxychloroquine for the Treatment of SARS-CoV2 (COVID 19) : Pharmacokinetic Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples from D1 to Day 9 of the hydroxychloroquine treatment'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Hydroxychloroquine is not yet used for the Treatment of SARS-CoV2 (COVID 19)', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-13', 'studyFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2020-11-10', 'lastUpdatePostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'residual plasma concentration', 'timeFrame': 'Day 3', 'description': 'residual plasma concentration measured before re-administration of the treatment'}, {'measure': 'residual plasma concentration', 'timeFrame': 'Day 5', 'description': 'residual plasma concentration measured before re-administration of the treatment'}, {'measure': 'residual plasma concentration', 'timeFrame': 'Day 7', 'description': 'residual plasma concentration measured before re-administration of the treatment'}, {'measure': 'residual plasma concentration', 'timeFrame': 'Day 9', 'description': 'residual plasma concentration measured before re-administration of the treatment'}], 'secondaryOutcomes': [{'measure': 'The number of days without artificial ventilation', 'timeFrame': 'Day 28', 'description': 'number of days without artificial ventilation'}, {'measure': 'The length of hospital stay in intensive care', 'timeFrame': 'Day 28', 'description': 'The length of hospital stay in intensive care measured in days number'}, {'measure': 'Survival', 'timeFrame': 'Day 28', 'description': 'Statu alive or death'}, {'measure': 'Viral replication in the control bronchoalveolar lavage fluid on Day 7', 'timeFrame': 'Day 7', 'description': 'Viral replication on Day 7 measured by biological analysis of the bronchoalveolar lavage fluid'}, {'measure': 'Viral replication in the control bronchoalveolar lavage fluid on Day 14', 'timeFrame': 'Day 14', 'description': 'Viral replication on Day 14 measured by biological analysis of the bronchoalveolar lavage fluid'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'hydroxychloroquine', 'pharmacokinetics', 'bronchoalveolar lavage fluid', 'Intensive Care Unit'], 'conditions': ['COVID-19 Pneumonia']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in intensive care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient ≥ 18 years old,\n* Hospitalized in intensive care, intubated and ventilated\n* With COVID-19 pneumonia confirmed by Rt-PCR,\n* Having as specific treatment hydroxychloroquine, whatever the dosage regimen\n* 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\n* Person affiliated to a social security scheme or equivalent\n\nExclusion Criteria:\n\n* Minor patients\n* Patients refusing to participate in the study\n* Person participating in another research including an exclusion period still in progress.\n* 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\n* 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).\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT04625218', 'acronym': 'CHLORO-VID', 'briefTitle': 'Hydroxychloroquine for the Treatment of SARS-CoV2 (COVID 19) : Pharmacokinetic Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Hydroxychloroquine for the Treatment of SARS-CoV2 (COVID 19) in the Critically Ill Patient: Pharmacokinetic Study. (CHLORO-VID)', 'orgStudyIdInfo': {'id': 'RC31/20/0155'}, 'secondaryIdInfos': [{'id': '2020-A01094-35', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Stéphanie RUIZ, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}