Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT04307693
Status:
TERMINATED
Last Update Posted:
2020-05-27
First Post:
2020-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
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': 'D061466', 'term': 'Lopinavir'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, open labelled, randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'whyStopped': 'Terminated early because no patients were further enrolled since mid-Apr 2020.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-25', 'studyFirstSubmitDate': '2020-03-10', 'studyFirstSubmitQcDate': '2020-03-12', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viral load', 'timeFrame': 'hospital day 3, 5, 7, 10, 14, 18', 'description': 'Area under the curve (AUC) of Ct value or viral copies number per mL'}], 'secondaryOutcomes': [{'measure': 'Viral load change', 'timeFrame': 'hospital day 3, 5, 7, 10, 14, 18', 'description': 'Viral load change (log10 viral load assessed by reverse transcription-PCR) during hospital day 3, 5, 7, 10, 14, 18)'}, {'measure': 'Time to clinical improvement (TTCI)', 'timeFrame': 'up to 28 days', 'description': 'Time to clinical improvement (TTCI) is defined as the time to normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough within at least 72 hours'}, {'measure': 'Percentage of progression to supplemental oxygen requirement by day 7', 'timeFrame': 'hospital day 7', 'description': 'Percentage of progression to supplemental oxygen requirement by day 7'}, {'measure': 'Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7', 'timeFrame': 'hospital day 7', 'description': 'Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7'}, {'measure': 'Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission', 'timeFrame': 'up to 28 days', 'description': 'Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission'}, {'measure': 'Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7', 'timeFrame': 'hospital day 7', 'description': 'Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7'}, {'measure': 'adverse effects', 'timeFrame': 'up to 28 days', 'description': 'Safety and tolerability, as assessed by adverse effects'}, {'measure': 'Concentration of Lopinavir/ritonavir and hydroxychloroquine', 'timeFrame': '1, 2, 4, 5, 12 hours after taking intervention medicine', 'description': 'Concentration of Lopinavir/ritonavir and hydroxychloroquine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '32618282', 'type': 'DERIVED', 'citation': 'Lipsitch M, Perlman S, Waldor MK. Testing COVID-19 therapies to prevent progression of mild disease. Lancet Infect Dis. 2020 Dec;20(12):1367. doi: 10.1016/S1473-3099(20)30372-8. Epub 2020 May 6. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'In vitro studies revealed that lopinavir/ritonavir and hydroxychloroquine have antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there is no clinical studies on the reduction of viral load in patients with COVID-19. This study investigate whether lopinavir/ritonavir or hydroxychloroquine reduces viral load from respiratory specimen in patients with mild COVID-19.', 'detailedDescription': 'This multicenter study is an open-labelled, randomized clinical trial for 1:1:1 ratio of lopinavir/ritonavir, hydroxychloroquine, or control arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed mild COVID-19 (NEWS scoring system 0-4)\n\nExclusion Criteria:\n\n* unable to take oral medication\n* pregnancy or breast feeding\n* immunocompromised patients\n* creatinine clearance (CCL) \\< 30 mL/min\n* aspartate transaminase (AST) or alanine transaminase (ALT) \\> 5 times Upper limit of normal (ULN)'}, 'identificationModule': {'nctId': 'NCT04307693', 'briefTitle': 'Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)', 'orgStudyIdInfo': {'id': 'S2020-0472-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lopinavir/ritonavir', 'description': 'Lopinavir/ritonavir 200mg/100mg 2 tablets by mouth, every 12 hours for 7-10 days', 'interventionNames': ['Drug: Lopinavir/ritonavir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine 400mg by mouth, every 24 hours for 7-10 days', 'interventionNames': ['Drug: Hydroxychloroquine sulfate']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No lopinavir/ritonavir and hydroxychloroquine'}], 'interventions': [{'name': 'Lopinavir/ritonavir', 'type': 'DRUG', 'otherNames': ['Kaletra'], 'description': 'Lopinavir / Ritonavir tablet', 'armGroupLabels': ['Lopinavir/ritonavir']}, {'name': 'Hydroxychloroquine sulfate', 'type': 'DRUG', 'otherNames': ['Oxiklorin'], 'description': 'Hydroxychloroquine sulfate tablet', 'armGroupLabels': ['Hydroxychloroquine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center, University of Ulsan College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sung-Han Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}