Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-30 @ 1:24 PM
Study NCT ID:
NCT04323332
Status:
UNKNOWN
Last Update Posted:
2020-03-26
First Post:
2020-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Chinese Medicine for Severe COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2020-03-08', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay (days)', 'timeFrame': 'First treatment date up to 3 months'}], 'secondaryOutcomes': [{'measure': 'Duration (days) of supplemental oxygenation', 'timeFrame': 'First treatment date up to 3 months'}, {'measure': 'CT imaging changes', 'timeFrame': 'First treatment date up to 3 months'}, {'measure': 'Mortality rate', 'timeFrame': 'First treatment date up to 3 months'}, {'measure': 'Time to Clinical Improvement (TTCI)', 'timeFrame': 'First treatment date up to 3 months'}, {'measure': 'The pneumonia severity index scores', 'timeFrame': 'First treatment date up to 3 months', 'description': 'The pneumonia severity index is a clinical tool helping in the risk stratification of patients with community-acquired pneumonia. It ranges from 0-395 scores and a higher score indicates higher death risk.'}, {'measure': 'Time to COVID-19 nucleic acid testing negativity in throat swab', 'timeFrame': 'First treatment date up to 3 months'}, {'measure': 'Blood immune cell count', 'timeFrame': 'Baseline, 7 and/ or 14 days', 'description': 'Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline'}, {'measure': 'Serum inflammatory markers', 'timeFrame': 'Baseline, 7 and/ or 14 days', 'description': 'Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.'}, {'measure': 'Erythrocyte sedimentation rate', 'timeFrame': 'Baseline, 7 and/ or 14 days', 'description': 'Changes in erythrocyte sedimentation rate from baseline.'}, {'measure': 'Platelet and D-dimer changes', 'timeFrame': 'Baseline, 7 and/ or 14 days', 'description': 'Changes in platelets and D-dimers from baseline.'}, {'measure': 'Creatinine changes', 'timeFrame': 'Baseline, 7 and/ or 14 days', 'description': 'Changes in serum creatinine from baseline.'}, {'measure': 'Muscle enzymes changes', 'timeFrame': 'Baseline, 7 and/ or 14 days', 'description': 'Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.'}, {'measure': 'Usage of antibiotics', 'timeFrame': 'First treatment date up to 3 months', 'description': 'Dosing time and amounts of antibiotics；the categories of the antibiotics'}, {'measure': 'Usage of glucocorticoids', 'timeFrame': 'First treatment date up to 3 months', 'description': 'Dosing time and amounts of glucocorticoids'}, {'measure': 'Frequency of adverse events', 'timeFrame': 'First treatment date up to 3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Traditional Chinese Medicine', 'Pneumonia', 'Coronavirus'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': "In December 2019, a new type of pneumonia, COVID-2019 outbroke in Wuhan ,China, and currently the infected has been reported in more than at least 75 countries.\n\nPatients with severe COVID-19 have rapid disease progression and high mortality rate. This may attribute to the excessive immune response caused by cytokine storm. Strategies based on anti-virus drugs and treatments against symptoms have now been employed. However, these managements can't effectively treat the lethal lung injury and uncontrolled immune responses, especially in the elderly with severe COVID-19. Traditional Chinese Medicine (TCM), which treats the disease from anther perspective, has achieved satisfactory results. National Health Commission of China released a series of policies to enhance the administration of TCM prescriptions.\n\nThis study is aimed to evaluate the efficacy and safety of Traditional Chinese Medicine as an adjuvant treatment for severe COVID-19."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Patients were diagnosed as severe COVID-19 according to the Coronavirus disease (COVID-19) Treatment Guidance (Six edition)\n2. Patients received a combined treatment of TCM and conventional therapy, or only conventional therapy.\n\nKey Exclusion Criteria:\n\n1. Age \\>85 years\n2. After cardiopulmonary resuscitation\n3. Patients combined with other organ failure or conditions need ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation.\n4. Respiratory failure and need mechanical ventilation'}, 'identificationModule': {'nctId': 'NCT04323332', 'briefTitle': 'Traditional Chinese Medicine for Severe COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences'}, 'officialTitle': 'A Retrospective Cohort Study to Evaluate the Efficacy and Safety of Traditional Chinese Medicine as an Adjuvant Treatment for Patients With Severe COVID-19', 'orgStudyIdInfo': {'id': '2020XLA015-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Traditional Chinese Medicine', 'description': 'TCM prescription and conventional treatments', 'interventionNames': ['Drug: Traditional Chinese Medicine Prescription']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'conventional treatments'}], 'interventions': [{'name': 'Traditional Chinese Medicine Prescription', 'type': 'DRUG', 'description': 'Traditional Chinese Medicine Prescriptions have been recommended according to the Guidelines for the treatment of COVID-19 issued by National Health Commission of the PRC.', 'armGroupLabels': ['Traditional Chinese Medicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100091', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Hao Li, Prof.', 'role': 'CONTACT', 'email': 'xyhplihao1965@126.com', 'phone': '01062835088'}], 'facility': 'Hao Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hao Li, Professor', 'role': 'CONTACT', 'email': 'xyhplihao1965@126.com', 'phone': '+0086-133113382093'}], 'overallOfficials': [{'name': 'Hao Li, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Li Hao', 'investigatorAffiliation': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences'}}}}