Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05366205
Status:
UNKNOWN
Last Update Posted:
2022-05-09
First Post:
2022-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Function in Elderly Patients With Mild to Moderate COVID-19 on Hemodialysis
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': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2022-04-30', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD4 lymphocyte counts', 'timeFrame': 'Baseline to discharge date, an average of 3 weeks'}, {'measure': 'lymphocyte count', 'timeFrame': 'Baseline to discharge date, an average of 3 weeks'}, {'measure': 'T-lymphocyte subsets', 'timeFrame': 'Baseline to discharge date, an average of 3 weeks', 'description': 'CD3+, CD4+, CD8+'}], 'secondaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': 'Baseline to discharge date, an average of 3 weeks'}, {'measure': 'change in white blood cell count', 'timeFrame': 'Baseline to discharge date, an average of 3 weeks'}, {'measure': 'change in hemoglobin', 'timeFrame': 'Baseline to discharge date, an average of 3 weeks'}, {'measure': 'change in albumin', 'timeFrame': 'Baseline to discharge date, an average of 3 weeks'}, {'measure': 'change in C-Reactive Protein', 'timeFrame': 'Baseline to discharge date, an average of 3 weeks'}, {'measure': 'change in procalcitonin', 'timeFrame': 'Baseline to discharge date, an average of 3 weeks'}, {'measure': 'change in nutritional risk screening 2002(NRS 2002) score', 'timeFrame': 'Baseline to discharge date, an average of 3 weeks', 'description': 'Scores range from 0 to 7，a score greater than or equal to 3 indicates nutritional risk'}, {'measure': 'change in mini nutritional assessment short-form（MNA- SF） score', 'timeFrame': 'Baseline to discharge date, an average of 3 weeks', 'description': 'Scores range from 0 to 14，a score of 0 to 7 indicates malnutrition，8-11 indicates risk of malnutrition, 12-14 indicates normal nutrition'}, {'measure': 'change in Geriatric nutritional risk index(GNRI) score', 'timeFrame': 'Baseline to discharge date, an average of 3 weeks', 'description': 'Higher scores mean a worse outcome'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Baseline to discharge date, an average of 3 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Hemodiafiltration', 'immune function', 'Oral nutritional supplement'], 'conditions': ['COVID-19', 'Hemodiafiltration']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will focus on the effects of early oral nutritional supplementation on immune function in elderly patients with mild to moderate COVID-19 on maintenance hemodialysis. The purpose of this study is to determine whether early oral nutritional supplementation can improve immune function and clinical outcomes.', 'detailedDescription': 'COVID-19 is in the midst of a global pandemic. Elderly patients are often susceptible and at high risk. Elderly patients on maintenance hemodialysis are often accompanied by a variety of complications, malnutrition is a common complication with an incidence of 23-73%. Due to a variety of risk factors, COVID-19 infection tends to develop into severe disease, and it takes longer for nucleic acid to turn negative.\n\nThis randomized controlled trial will focus on the effects of early oral nutritional supplementation on immune function in elderly patients with mild to moderate COVID-19 on maintenance hemodialysis. The purpose of this study is to determine whether early oral nutritional supplementation can improve immune function and clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 60 and above;\n2. Patients receiving hemodialysis with clinically confirmed end-stage renal disease\n3. Positive diagnosis of COVID-19 by RT-PCR nasopharyngeal swab was classified as mild or moderate type\n4. Patients who can eat on their own;\n5. Patients had good compliance, fully understood the study content and signed informed consent.\n\nExclusion Criteria:\n\n1. Contraindications of oral nutritional supplementation, such as intestinal obstruction and intestinal ischemia.\n2. In an unstable state of vital signs such as shock.\n3. In acute pancreatitis, cholecystitis acute attack period and 3 months after the last attack\n4. Patients with moderate to severe cognitive impairment or mental diseases;\n5. People who are allergic to intestinal nutrients\n6. Refuse oral nutritional supplements'}, 'identificationModule': {'nctId': 'NCT05366205', 'briefTitle': 'Immune Function in Elderly Patients With Mild to Moderate COVID-19 on Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Prospective, Randomized Controlled Study on Immune Function Regulation by Strengthening Early Oral Nutritional Supplementation in Elderly Patients With Mild to Moderate COVID-19 on Hemodialysis', 'orgStudyIdInfo': {'id': 'RJYY01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral nutritional supplements', 'description': 'Patients in this arm will receive oral nutritional supplements 24-48 hours after admission，which is enteral nutrition emulsion(TPF-T).', 'interventionNames': ['Dietary Supplement: Oral nutritional supplement']}, {'type': 'SHAM_COMPARATOR', 'label': 'nutrition consultation', 'description': 'Patients in this arm will receive nutrition consultation was given in addition to basic treatment.', 'interventionNames': ['Behavioral: Nutrition consultation']}], 'interventions': [{'name': 'Oral nutritional supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Enteral nutritional emulsion(TPF-T) will be given by oral intake,400ml per day, lasting for 7-10 days.', 'armGroupLabels': ['Oral nutritional supplements']}, {'name': 'Nutrition consultation', 'type': 'BEHAVIORAL', 'description': 'Nutritional treatment advice will be given', 'armGroupLabels': ['nutrition consultation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yongmei Shi, MD', 'role': 'CONTACT', 'email': 'shi.yongmei@163.com', 'phone': '00862164370045', 'phoneExt': '673376'}, {'name': 'Qianwen Jin, MD', 'role': 'CONTACT', 'email': 'jqw12247@rjh.com.cn', 'phone': '008618701708006'}], 'overallOfficials': [{'name': 'Yongmei Shi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate chief physician', 'investigatorFullName': 'SHI YONGMEI', 'investigatorAffiliation': 'Ruijin Hospital'}}}}