Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-24 @ 5:06 AM
Study NCT ID:
NCT04263402
Status:
UNKNOWN
Last Update Posted:
2020-03-17
First Post:
2020-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-14', 'studyFirstSubmitDate': '2020-02-02', 'studyFirstSubmitQcDate': '2020-02-07', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of disease remission', 'timeFrame': 'day 7', 'description': 'For mild patients: disease remission refers to relieved symptoms with improved lung CT; For severe patients: disease remission refers to relieved symptoms with improved lung CT; or SPO2\\>93% or PaO2/FiO2 \\>300mmHg.'}, {'measure': 'Rate and time of entering the critical stage', 'timeFrame': 'day 7', 'description': 'the critical stage refers to respiratory failure that occurs and requires mechanical ventilation, shock, or having other organ failure that needs ICU monitoring and treatment.'}], 'secondaryOutcomes': [{'measure': 'Rate of normal tempreture', 'timeFrame': 'day 7', 'description': 'Rate of patients without fever at day 7'}, {'measure': 'Rate of respiratory symptom remission', 'timeFrame': 'day 7', 'description': 'Rate of patients with respiratory symptom remission at day 7'}, {'measure': 'Rate of lung imaging recovery', 'timeFrame': 'day 7', 'description': 'Rate of patients with lung imaging recovery at day 7'}, {'measure': 'Rate of laboratory indicator recovery', 'timeFrame': 'day 7', 'description': 'Rate of patients with laboratory indicator recovery at day 7'}, {'measure': 'Rate of undetectable viral RNA', 'timeFrame': 'day 7', 'description': 'Rate of patients withundetectable viral RNA at day 7'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['2019-nCoV Severe Pneumonia']}, 'descriptionModule': {'briefSummary': 'At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.Meet the definition of severe pneumonia(Comply with any of the followings):\n\n1. Shortness of breath,RR≥30 bpm;\n2. In a resting state:SPO2≤93%;\n3. PaO2/FiO2≤300mmHg.\n\n2.2019-nCoV nucleic acid test was positive.\n\n3.CT of the lung conformed to the manifestation of viral pneumonia.\n\nExclusion Criteria:\n\n1. dying state (i.e. survival time is less than 24 hours);\n2. progressive malignant tumor with life expectancy less than 6 months;\n3. immunosuppressive status(patients using immunosuppressants or chemotherapeutic drugs)\n4. underlying diseases requiring long-term glucocorticoid treatment in the past 6 months or short-term glucocorticoid therapy in the past 4 weeks;\n5. pregnancy\n6. patients with glucocorticoid taboos'}, 'identificationModule': {'nctId': 'NCT04263402', 'briefTitle': 'The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia', 'orgStudyIdInfo': {'id': 'TJ20200201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methylprednisolone(<40mg/d)', 'interventionNames': ['Drug: Methylprednisolone']}, {'type': 'EXPERIMENTAL', 'label': 'Methylprednisolone(40~80mg/d)', 'interventionNames': ['Drug: Methylprednisolone']}], 'interventions': [{'name': 'Methylprednisolone', 'type': 'DRUG', 'description': 'Patients in the Group I will receive basic symptomatic supportive treatment,plus methylprednisolone(\\<40mg/d intravenous drip for 7 days).', 'armGroupLabels': ['Methylprednisolone(<40mg/d)']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'description': 'Patients in the Group II will receive basic symptomatic supportive treatment,plus methylprednisolone(40\\~80mg/d intravenous drip for 7 days).', 'armGroupLabels': ['Methylprednisolone(40~80mg/d)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Ning, professor', 'role': 'CONTACT', 'email': 'qning@vip.sina.com'}, {'name': 'Meifang Han, professor', 'role': 'CONTACT', 'email': 'mfhan@foxmail.com'}], 'facility': 'Department and Institute of Infectious Disease', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Qing Ning, Professor', 'role': 'CONTACT', 'email': 'qning@vip.sina.com', 'phone': '+8613971521450'}, {'name': 'Meifang Han, Professor', 'role': 'CONTACT', 'email': 'mfhan@foxmail.com', 'phone': '+8613986093605'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qin Ning', 'investigatorAffiliation': 'Tongji Hospital'}}}}