Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-31 @ 1:29 PM
Study NCT ID:
NCT04909905
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2021-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glutamine Supplementation and Short-term Mortality in 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': 'D005973', 'term': 'Glutamine'}, {'id': 'C054122', 'term': 'alanylglutamine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-04', 'studyFirstSubmitDate': '2021-05-30', 'studyFirstSubmitQcDate': '2021-06-01', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU mortality', 'timeFrame': '7 days', 'description': 'Short-term ICU mortality for patients admitted in our ICU \\& signed for study drugs, who will expire during the study'}], 'secondaryOutcomes': [{'measure': 'Neutrophil/lymphocyte ratio (NLR)', 'timeFrame': '7 days', 'description': 'Assessing NLR at day zero \\& day 7 to monitor inflammatory response'}, {'measure': 'D- dimer level', 'timeFrame': '7 days', 'description': 'Assessing D-dimer level at day zero \\&day 7 to monitor coagulability status'}, {'measure': 'ICU stay', 'timeFrame': '7 days', 'description': 'Period of patients admission in ICU within duration of study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '32341077', 'type': 'BACKGROUND', 'citation': 'Mehta S. Nutritional status and COVID-19: an opportunity for lasting change? Clin Med (Lond). 2020 May 15;20(3):270-273. doi: 10.7861/clinmed.2020-0187.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of parenteral L-Glutamine supplementation added to enteral nutrition on short-term ICU mortality (7 days) in Covid-19 diseased patients.', 'detailedDescription': 'A written informed consent will be taken from the patients or their relatives. Patients with diagnosis of covid-19 with enteral nutrition will be enrolled. Patients will be randomly assigned to receive either standard enteral nutrition (Group EN) or intravenous glutamine supplementation to enteral nutrition (group GN) in a dose of glutamine of 0.4 g/kg/day during ICU stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of covid-19 diseased patients admitted to the ICU with enteral nutrition.\n\nExclusion Criteria:\n\n* Renal failure (creatinine \\>180 mmol/l)\n* Hepatic failure (bilirubin \\>40 mmol/l, alanine aminotransferase \\>100 U/l and aspartate aminotransferase \\>100 U/l)\n* Severe neutropenia (\\<500 cells/mm3)\n* Patients receiving cytotoxic, radiation and/or steroid therapy\n* Hemodynamic instability'}, 'identificationModule': {'nctId': 'NCT04909905', 'briefTitle': 'Glutamine Supplementation and Short-term Mortality in Covid-19', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Impact of Glutamine Supplementation Upon the Short-term Mortality of COVID-19 Diseased Patients Admitted in ICU: A Double Blind Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '17300609'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group EN (standard enteral nutrition)', 'description': 'Patients receive standard enteral nutrition according to ICU nutrition protocol during 7days from admission', 'interventionNames': ['Dietary Supplement: Standard enteral nutrition']}, {'type': 'EXPERIMENTAL', 'label': 'Group GN (glutamine supplemented enteral nutrition)', 'description': 'Patients receive intravenous glutamine supplementation to enteral nutrition in a dose of glutamine of 0.4 g/kg/day during 7 days from admission.', 'interventionNames': ['Combination Product: Glutamine']}], 'interventions': [{'name': 'Standard enteral nutrition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Standard enteral nutrition according to ICU nutrition protocol for 7 days', 'armGroupLabels': ['Group EN (standard enteral nutrition)']}, {'name': 'Glutamine', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Dipeptiven'], 'description': 'Intravenous glutamine supplementation to enteral nutrition in a dose of dose of glutamine of 0.4 g/kg/day for 7days', 'armGroupLabels': ['Group GN (glutamine supplemented enteral nutrition)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Assuit universi', 'city': 'Asyut', 'state': 'Assuit', 'country': 'Egypt', 'facility': 'Omar Soliman', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Omar Soliman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Omar makram'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia and ICU', 'investigatorFullName': 'Omar Makram Soliman', 'investigatorAffiliation': 'Assiut University'}}}}