Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
Study NCT ID:
NCT04522466
Status:
TERMINATED
Last Update Posted:
2020-09-07
First Post:
2020-08-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Stop of the study by competent authority (ANSM)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-04', 'studyFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of hydroxychloroquine (HCQ)', 'timeFrame': 'Up to day 21', 'description': 'measured blood concentration by blood sample results.'}], 'secondaryOutcomes': [{'measure': 'Correlation between hydroxychloroquine (HCQ) concentration and cardiac toxicity (QT interval)', 'timeFrame': 'Up to day 21', 'description': 'measured by blood sample and electrocardiogram results.'}, {'measure': 'Correlation between Pharmacokinetic (concentration) and pharmacodynamic (viral load) of hydroxychloroquine (HCQ)', 'timeFrame': 'Day 1, Day 3, Day 5, Day 7, Day 14, Day 21', 'description': 'measured by blood sample'}, {'measure': 'Pharmacokinetic model', 'timeFrame': 'Up to day 21', 'description': 'Pharmacokinetic (area under the curve) analysis will be performed using a population approach with a non-linear mixed effects model.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Hydroxychloroquine', 'COVID-19', 'Intensive care unit', 'Pharmacokinetics'], 'conditions': ['Sars-CoV2']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients 18 years of age and older\n* Patients hospitalized in the intensive care unit infected with CoV-2-SARS for whom a diagnosis of respiratory CoV-2-SARS infection has been made by nasopharyngeal swab or deep respiratory sampling.\n* Patient receiving HCQ treatment as part of care or as part of a clinical trial.\n* Patient affiliated or entitled to a social security scheme\n\nExclusion Criteria:\n\n* Hypersensitivity to the active substances or to any of the following excipients: lactose monohydrate, povidone, corn starch, magnesium stearate.\n* Retinopathies\n* Combination with citalopram, escitalopram, hydroxyzine, domperidone and piperazine due to increased risk of ventricular rhythm disturbances, including torsades de pointes.\n* Patient with known QT prolongation\n* Known deficit in G6PD\n* Pregnant woman'}, 'identificationModule': {'nctId': 'NCT04522466', 'acronym': 'PREAVIS', 'briefTitle': 'Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients', 'orgStudyIdInfo': {'id': '20CH065'}, 'secondaryIdInfos': [{'id': '2020-001281-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients infected by SARS-CoV-2 treated by Hydroxychloroquine', 'description': 'Blood sample on patients infected by SARS-CoV-2 treated by Hydroxychloroquine', 'interventionNames': ['Drug: Hydroxychloroquine (HCQ)']}], 'interventions': [{'name': 'Hydroxychloroquine (HCQ)', 'type': 'DRUG', 'description': 'Hydroxychloroquine (HCQ) will be administered as usual practice: dosage is adjusted to maintain a concentration between 1 and 2 mg/L.\n\nMeasure pharmacokinetics and pharmacodynamics of Hydroxychloroquine (HCQ).', 'armGroupLabels': ['Patients infected by SARS-CoV-2 treated by Hydroxychloroquine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montélimar', 'country': 'France', 'facility': 'Groupement Hospitalier des Portes de Province', 'geoPoint': {'lat': 44.55468, 'lon': 4.75469}}, {'city': 'Roanne', 'country': 'France', 'facility': 'Centre Hospitalier de Roanne', 'geoPoint': {'lat': 46.03624, 'lon': 4.06802}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Clinique Mutualiste', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Sophie PERINEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'CHU Saint-Etienne - Laboratoire de Pharmacologie - Toxicologie - Gaz du sang', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}