Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-09 @ 10:00 PM
Study NCT ID:
NCT05835102
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2023-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Nutritional Indices on the Prognosis of Patients With SARS-CoV-2 Infection
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2023-04-23', 'studyFirstSubmitQcDate': '2023-04-27', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': 'October 2022 to January 2023', 'description': 'Death due to Respiratory failure or other diseases'}, {'measure': 'cure', 'timeFrame': 'October 2022 to January 2023', 'description': 'the patients with SARS-CoV-2 infection are cured and discharged from hospital'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prognostic nutritional index', 'geriatric nutritional risk index', 'pectoralis muscle index', 'prognosis'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': "With the decline of virulence after the mutation of the SARS-CoV-2 , based on the national life and health and national development needs, the domestic SARS-CoV-2 infection epidemic prevention policy has changed, and the number of people infected by the SARS-CoV-2 has increased. Nutritional status is an indicator of human health and plays an important role in fighting disease. Malnutrition has been found to correlate with prognosis in patients infected with the SARS-CoV-2 infection . Timely identification and assessment of the patient's nutritional status and early implementation of relevant nutritional intervention are conducive to the recovery of the patient's condition.\n\nIn clinical practice, it is necessary to improve nutrition as an aspect of the comprehensive diagnosis and treatment of patients with SARS-CoV-2 infection, but there is still a lack of relevant nutritional indicators or models to simply and accurately assess the nutritional status of patients.The purpose of this study was to evaluate the effects of PNI, NRI, GNRI, albumin level, vitamin D, chest muscle area and density on the clinical characteristics and prognosis of patients with SARS-CoV-2 infection, to find the nutritional predictors of severe disease in patients with SARS-CoV-2 infection, and to establish a simpler and more accurate nutritional evaluation model. To provide evidence for targeted nutritional interventions in patients with SARS-CoV-2 infection.", 'detailedDescription': 'Patients with SARS-CoV-2 infection attending the Second Affiliated Hospital of Chongqing Medical University were included in the retrospective study. Participants met the inclusion and exclusion criteria. Data to be collected include age, sex, height, and weight at initial treatment; Blood routine, liver function, kidney function, coagulation function, electrolytes, vitamin D, C-reactive protein, ferritin; CT and MRI information; Underlying diseases, complications, treatment options, etc. Follow up patients until discharge or death. After the data collection, statistical methods such as chi-square test and logistic regression analysis were used to evaluate the impact of nutritional factors on the prognosis of patients infected with SARS-CoV-2 infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a positive SARS-CoV-2 nucleic acid test or a positive SARS-CoV-2 antigen test.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with a positive SARS-CoV-2 nucleic acid test or a positive SARS-CoV-2 antigen test.\n\nExclusion Criteria:\n\n1. People with end-stage malignant tumors;\n2. Nutritional intake disorders, mainly dependent on enteral and parenteral nutrition supporters;\n3. paralyzed;\n4. Intravenous drug addicts.'}, 'identificationModule': {'nctId': 'NCT05835102', 'briefTitle': 'Influence of Nutritional Indices on the Prognosis of Patients With SARS-CoV-2 Infection', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Study on the Influence of Nutritional Indices on the Prognosis of Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection', 'orgStudyIdInfo': {'id': '2023-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients With SARS-CoV-2 Infection', 'description': 'Patients who test positive for SARS-CoV-2 nucleic acid or SARS-CoV-2 antigen'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juan Kang, M.D.', 'role': 'CONTACT', 'email': '68368892@qq.com', 'phone': '+8613996112052'}], 'facility': 'The Second Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Juan Kang, M.D.', 'role': 'CONTACT', 'email': '68368892@qq.com', 'phone': '8613996112052'}], 'overallOfficials': [{'name': 'Juan Kang, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'The Second Affiliated Hospital of Chongqing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Juan Kang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Juan Kang', 'investigatorAffiliation': 'The Second Affiliated Hospital of Chongqing Medical University'}}}}