Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT05110651
Status:
WITHDRAWN
Last Update Posted:
2021-11-08
First Post:
2020-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Danish Pre-HCQ COVID Dialysis Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], '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'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter parallel-group open-label randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-04-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2020-03-29', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Duration of hospitalization', 'timeFrame': '3 months', 'description': 'Duration in days of hospitalization due to SARS-CoV-2 infection'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': '3 months', 'description': 'Duration in day of mechanical ventilation due to SARS-CoV-2 infection'}, {'measure': 'Duration of admission to intensive care', 'timeFrame': '3 months', 'description': 'Duration in days of admission to intensive care due to SARS-CoV-2 infection'}, {'measure': 'Bone marrow suppression', 'timeFrame': '3 months', 'description': 'Number of patients with leucopeni \\< 3000/μL within the study period'}, {'measure': 'Hepatic dysfunction', 'timeFrame': '3 months', 'description': 'Number of patients with hepatic dysfunction as defined by an alanine transaminaease \\> 250U/I within the study period'}, {'measure': 'Cardiac injury', 'timeFrame': '3 months', 'description': 'Number of patients with evidence of cardiac injury (creatinine kinase-myocardial band \\> 5μg/L) within the study period'}, {'measure': 'Sudden cardiac death', 'timeFrame': '3 months', 'description': 'Number of patients with sudden cardiac death within the study period'}, {'measure': 'QTc prolongation', 'timeFrame': '3 months', 'description': "Number of patients with QTc prolongation (Bazett's formula; \\>\\> 450 ms in males and 460 ms in females)"}, {'measure': 'Positiv SARS-CoV-2 antibody', 'timeFrame': '3 months', 'description': 'Number of patients with positive SARS-CoV-2 antibody at 3 months'}], 'primaryOutcomes': [{'measure': 'Hospitalization due to SARS-CoV-2 infection', 'timeFrame': '3 months', 'description': 'Number of patients hospitalized due to COVID-19'}], 'secondaryOutcomes': [{'measure': 'SARS-CoV-2 infection', 'timeFrame': '3 months', 'description': 'Number of patients with verified SARS-CoV-2 infection'}, {'measure': 'SARS-CoV-2 viral load', 'timeFrame': '3 months', 'description': 'SARS-CoV-2 viral count as defined by real-time RNA polymerase chain reaction'}, {'measure': 'All-cause mortality', 'timeFrame': '3 months', 'description': 'Number of deaths within the study period'}, {'measure': 'Requirement of mechanical ventilation', 'timeFrame': '3 months', 'description': 'Number of patients requiring mechanical ventilation due to SARS-CoV-2 infection within the study period'}, {'measure': 'Admission to intensive care', 'timeFrame': '3 months', 'description': 'Number of patients admitted to intensive care due to SARS-CoV-2 infection within the study period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'Hydroxychloroquine has been shown to inhibit replication of SARS-CoV-2 in vitro. The presented multicenter parallel-group open-label randomized clinical trial aims to investigate the efficacy of prophylactic hydroxychloroquine on mitigation of risk of hospitalization due to COVID-19 in patients with end-stage renal disease.', 'detailedDescription': 'The emergence of a novel betacoronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to a global pandemic with profound implications for public health. Despite sweeping containment measures, spread of infection is ongoing, with potential ramifications pertaining to availability of health care resources. Preliminary data from Wuhan, China and Northern Italy indicate particular vulnerability of patients \\>60 years with pre-existing comorbidity leading to increased risk of hospitalization and death. Currently, no specific treatment has demonstrated efficacy against infection with SARS-CoV-2 in a clinical trial. However, chloroquine has been shown to inhibit both viral entry and replication in infection with SARS-CoV-2 in vitro; albeit the specific mechanisms remain unchartered. Chloroquine is an amine acidotropic form of quinine. Previously a first-choice front-line drug for the treatment and prophylaxis of malaria, chloroquine remains one of the most prescribed drugs worldwide. The possible benefit of prophylactic treatment with hydroxychloroquine for mitigation of risk of manifest SARS-COV-2 remains untested. The on-going pandemic entails particular risk for patients on chronic dialysis; chronic dialysis is both associated with profound comorbidity but also requirement of continued ambulant hospital based treatment leading to increased exposure. Consequently, the potential benefit of preventative measures is greatly increased.\n\nAims and objectives The main objective of the following multicenter parallel-group open-label randomized clinical trial aims to investigate the possible benefit of initiating prophylactic hydroxychloroquine versus no treatment in patients on chronic dialysis for mitigation of risk related to SARS-CoV-2. The anticipated results will provide evidence as to the appropriateness of initiating prophylactic treatment for prevention of symptomatic SARS-CoV-2 in a vulnerable comorbid population with direct and immediate implications for clinical management and public health care beyond renal failure.\n\nMethods A total of 568 dialysis-treated patients with end-stage renal disease will be recruited from all dialysis centers (including satellites) in the Capital region. Patients will be randomized to either oral hydroxychloroquinesulphate 200mg once daily or no treatment for three months. The study is planned as a multicenter, open-label, parallel-group pragmatic randomized clinical study.\n\nAdditionally, 100 participants on chronic in-center hemodialysis treatment will be invited to participate in a sub-study focused on SARS-CoV-2 screening and prevention. Patients will undergo screening based on oro-pharyngeal sampling twice weekly. If ≥ 20% of infected patients are identified prior to development of symptoms, results will be applied to advise early SARS-CoV-2 screening in all chronic in-center hemodialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥18 years on chronic dialysis due to end-stage renal disease.\n* Competence to understand the study rationale, including potential risks and benefits associated with treatment, necessary for written informed consent.\n\nExclusion Criteria:\n\n* Prior verified SARS-CoV-2 infection.\n* Hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines\n* Electrocardiogram with QTc (Bazett's formula) \\> 450 ms in males and 460 ms in females\n* Patients reliant on digoxin or amiodarone treatment\n* Pre-existing psoriasis\n* Any pre-existing maculopathy with vision reduction\n* Prior sensorineural hearing loss\n* Pre-existing severe liver insufficiency (spontaneous international normalized ratio \\>1.5 within the last year)\n* Pre-existing epileptic disease requiring anti-epileptic medication\n* Pregnancy or lactation\n* Insurmountable Language Barrier\n* Participation in other ongoing intervention trials investigating COVID19-related outcomes"}, 'identificationModule': {'nctId': 'NCT05110651', 'briefTitle': 'The Danish Pre-HCQ COVID Dialysis Study', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Danish Pre-HCQ Dialysis Study: Hydroxychloroquine for Prevention of COVID19 in Dialysis-treated Patients With End-stage Renal Disease - A Multicenter Parallel-group Open Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'D-Pre-HCQ-D104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hydroxychloroquine', 'description': 'Oral hydroxychloroquine 200mg once daily', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'No treatment'}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'otherNames': ['Plaquenil'], 'description': 'Oral Hydroxychloroquine 200mg once daily Dose tapered if blood-hydroxychloroquine levels \\> 2000ng/ml', 'armGroupLabels': ['Hydroxychloroquine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'North Zealand Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'overallOfficials': [{'name': 'Nicholas Carlson, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Aggregated data will be available within 12 months of study completion', 'ipdSharing': 'YES', 'description': 'Aggregated de-identified individual participant data for primary and secondary outcomes measures will be made available', 'accessCriteria': 'All data access requests via email. Requestors will be required to sign a Data Access Agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nicholas Carlson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Nicholas Carlson', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}