Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT04909918
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2021-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Steroids on Inflammatory Response 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': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}], 'ancestors': [{'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'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011239', 'term': 'Prednisolone'}]}}, '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': '2021-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-04', 'studyFirstSubmitDate': '2021-05-30', 'studyFirstSubmitQcDate': '2021-05-30', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neutrophil/lymphocyte ratio (NLR)', 'timeFrame': '7 days', 'description': 'Monitoring of systemic inflammation by follow up of neutrophil/lymphocyte ratio (NLR) at days 0, 48 hour, 72 hour and at day 7 between the two study drugs'}], 'secondaryOutcomes': [{'measure': 'Interleukin-6 (IL-6) level', 'timeFrame': '7days', 'description': 'Serum level of IL-6 is taken before start drug study \\&at 7 days to assess inflammatory and immune response'}, {'measure': 'C-reactive protein (CRP) test', 'timeFrame': '3 days', 'description': 'CRP test is done before start drug study, at 48hour and 72 hour to assess inflammatory response'}, {'measure': 'Arterial oxygen tension/ inspired oxygen fraction (P/F ratio)', 'timeFrame': '3 days', 'description': 'Assessing p/f ratio from arterial blood gas to monitor oxygenation \\& need for upgrading of oxygen, this is monitored before start of study drugs,at 48 hour and 72 hour'}, {'measure': 'ICU stay', 'timeFrame': '7 days', 'description': 'Period of patients admission in the ICU'}, {'measure': 'ICU mortality', 'timeFrame': '7days', 'description': 'Short-term icu mortality (7 days) for patients will be expired'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '32714336', 'type': 'BACKGROUND', 'citation': 'Polidoro RB, Hagan RS, de Santis Santiago R, Schmidt NW. Overview: Systemic Inflammatory Response Derived From Lung Injury Caused by SARS-CoV-2 Infection Explains Severe Outcomes in COVID-19. Front Immunol. 2020 Jun 26;11:1626. doi: 10.3389/fimmu.2020.01626. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'we designed this study to observe the efficacy and safety of dexamethasone versus methylprednisolone in covid-19 diseased patients upon monitoring the inflammatory response and to compare the outcome when these steroids will be given in covid-19 diseased patients in our ICU.', 'detailedDescription': 'A written informed consent will be taken from the patients or their relatives. The study will involve adults (age 18-no limit years) who will be diagnosed covid-19 with destructive inflammatory immune response needing ICU admission to be run on steroid therapy.\n\nPatients will be assigned randomly to two groups (30 subjects each). The study drug will be delivered in opaque bags labeled "study drug" and in (Group D) intravenous dexamethasone 8 mg/day given for 7 days, in (Group M) intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age 18-no limit years) who will be diagnosed covid-19\n* With destructive inflammatory immune response needing ICU admission to be run on steroid therapy.\n\nExclusion Criteria:\n\n* Severe immunosuppression like HIV (Human immunodeficiency Virus)\n* Long term use of immunosuppressant for any other chronic illness\n* Pregnant or lactating females\n* Patients who are on chronic use of corticosteroids like asthma, rheumatoid arthritis.'}, 'identificationModule': {'nctId': 'NCT04909918', 'briefTitle': 'Impact of Steroids on Inflammatory Response in Covid-19', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Impact of Dexamethasone Versus Methylprednisolone Upon Neutrophil/Lymphocyte Ratio (NLR) in COVID-19 Diseased Patients Admitted in ICU', 'orgStudyIdInfo': {'id': '17300610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(Group D )Dexamethasone', 'description': 'Intravenous dexamethasone 8 mg/day given for 7 days', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': '(Group M) methylprednisolone', 'description': 'Intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days', 'interventionNames': ['Drug: Methylprednisolone']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Decadron'], 'description': 'Baseline laboratory \\& clinical data will be taken before and after the study drugs according to our protocol.Intravenous dexamethasone 8 mg/day given for 7 days', 'armGroupLabels': ['(Group D )Dexamethasone']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'otherNames': ['Solu-medrol'], 'description': 'Baseline laboratory \\& clinical data will be taken before and after the study drugs according to our protocol. Intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days', 'armGroupLabels': ['(Group M) methylprednisolone']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Assuit universi', 'city': 'Asyut', 'state': 'Assuit', 'country': 'Egypt', 'facility': 'Assiut university hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Omar Soliman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, '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'}}}}