Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-01-04 @ 7:21 AM
Study NCT ID:
NCT04341935
Status:
WITHDRAWN
Last Update Posted:
2021-06-10
First Post:
2020-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of DPP4 Inhibition on COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069476', 'term': 'Linagliptin'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Logistical challenges amid COVID-19 pandemic and lack of financial support', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-07', 'studyFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2020-04-07', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Glucose Llevels', 'timeFrame': 'Baseline, up to 2 weeks', 'description': 'Change in glucose control will be assessed via glucose levels obtained from blood serum samples'}], 'secondaryOutcomes': [{'measure': 'Changes in SpO2 levels', 'timeFrame': 'Baseline, up to 2 weeks', 'description': 'changes in SpO2 will be measured with a Pulseimetry, an indirect, non-invasive method'}, {'measure': 'Changes in Interleukin 6 (IL6)', 'timeFrame': 'Baseline, up to 2 weeks', 'description': 'Changes in IL 6 will be assessed from blood serum samples'}, {'measure': 'Changes in chest structures', 'timeFrame': 'Baseline, up to 2 weeks', 'description': 'Changes in Chest radiography (X-ray)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'SARS-Cov 2', 'DPP4', 'Type 2 diabetes'], 'conditions': ['Coronavirus Infection', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '32178593', 'type': 'RESULT', 'citation': 'Vankadari N, Wilce JA. Emerging WuHan (COVID-19) coronavirus: glycan shield and structure prediction of spike glycoprotein and its interaction with human CD26. Emerg Microbes Infect. 2020 Mar 17;9(1):601-604. doi: 10.1080/22221751.2020.1739565. eCollection 2020.'}, {'pmid': '32224164', 'type': 'RESULT', 'citation': 'Iacobellis G. COVID-19 and diabetes: Can DPP4 inhibition play a role? Diabetes Res Clin Pract. 2020 Apr;162:108125. doi: 10.1016/j.diabres.2020.108125. Epub 2020 Mar 26. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus (T2DM) as per American Diabetes Association (ADA) guidelines\n* Age ≥ 18\n* Confirmed COVID-19\n* Mild COVID-19 defined as any of the following: fever, malaise, cough, headache, sore throat, myalgia, nasal congestion, diarrhea\n* Moderate COVID-19 is defined as \\> 2 of the following in non-intubated patients: any symptom of mild disease, radiographic imaging (chest x-ray or lung ultrasound) with bilateral ground glass opacities or bilateral consolidations, SpO2 \\<90% up to 5L Nasal Cannula (NC)\n* No additional signs or symptoms of severe COVID-19.\n\nExclusion Criteria:\n\n* Type 1 Diabetes Mellitus (T1DM) diabetes, as per ADA guidelines\n* History of Diabetic Ketoacidosis (DKA)\n* History of acute pancreatitis\n* Chronic or Acute Renal Failure with Estimated Glomerular Filtration Rate (eGFR) \\< 30 ml/min/1.73 m2\n\nExclusion Criteria:\n\nT1DM diabetes, as per ADA guidelines, History of DKA, History of acute pancreatitis; Chronic or Acute Renal Failure with eGFR \\< 30 ml/min/1.73 m2'}, 'identificationModule': {'nctId': 'NCT04341935', 'briefTitle': 'Effects of DPP4 Inhibition on COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Effects of DPP4 Inhibition on COVID-19 Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '20200384'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DPP4 group', 'description': 'Participants in the Dipeptidyl Peptidase 4 (DPP4) group will receive Linagliptin in addition to standard of care insulin regimen as per hospital protocol during hospitalization for up to 14 days', 'interventionNames': ['Drug: Linagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Participants in the control group will receive only the standard of care insulin regimen as per hospital protocol during hospitalization for up to 14 days', 'interventionNames': ['Drug: Insulin regimen']}], 'interventions': [{'name': 'Linagliptin', 'type': 'DRUG', 'otherNames': ['Tradjenta'], 'description': '5 mg Linagliptin administered by mouth once daily', 'armGroupLabels': ['DPP4 group']}, {'name': 'Insulin regimen', 'type': 'DRUG', 'description': 'Standard of care insulin regimen as per hospital protocol', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Gianluca Iacobellis, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Gianluca Iacobellis', 'investigatorAffiliation': 'University of Miami'}}}}