Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT06907251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-02
First Post:
2025-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dapagliflozin for Long COVID Syndrome
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': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 month change in EQ-5D derived utility score.', 'timeFrame': '6 months', 'description': 'The 6 month change in EQ-5D derived utility score will be compared between the dapagliflozin and placebo arms within a multiple regression model.'}], 'secondaryOutcomes': [{'measure': 'Incident diabetes', 'timeFrame': '12 months', 'description': 'New diagnosis of diabetes mellitus (fasting glucose \\>7.0 mmol/L. HbA!c \\>6.5%, new prescription of diabetes pharmacotherapy)'}, {'measure': 'Cardiovascular Event', 'timeFrame': '12 months', 'description': 'Cardiovascular event - atrial fibrillation, ventricular tachycardia/fibrillation, acute coronary syndrome, heart failure, transient ischemic attack, stroke, cardiovascular death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'Long Covid syndrome', 'sars cov-2'], 'conditions': ['COVID - 19', 'Long COVID Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a randomized, placebo-controlled study. Patients with long COVID will be randomized to receive dapagliflozin or placebo for 12 months.', 'detailedDescription': 'This is a multi-centre, randomized, placebo-controlled trial (Figure 4). We will randomly assign patients with long COVID to 12 months of dapagliflozin 10 mg or placebo daily. The 10 mg daily dose of dapagliflozin was used in large clinical trials (44,48) and is the Health Canada approved dose for heart and kidney disease. Additionally, this dose was used in the MRI study of body composition (58) and the RCT in patients with acute COVID-19 (54).\n\nEligible patients with long COVID will be recruited from post COVID programs or advertisement through-multi-media. A total of 192 participants will be enrolled and this is anticipated to take 3 years. Participants will be followed for the entire duration of the study. Based on a study duration of 5 years (3-year recruitment, 2-year follow-up), patients will be followed for a median of 3.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': False, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older and willing and able to provide informed consent\n* Patients with a history of positive COVID-19 test (polymerase chain reaction or rapid test) or have been diagnosed with COVID-19 by a health care provider.\n* New or persistent symptoms at least 12 weeks from infection and present for at least 8 weeks that is not explained by an alternative diagnosis (64).\n* Women of childbearing potential (WOCBP) who, if sexually active, are willing to use to use at least one highly effective methods of contraception throughout the study.\n\nExclusion Criteria:\n\n* History of diabetes\n* Prior heart failure\n* Weight loss treatment with glucagon-like peptide-1 receptor agonists (e.g. liraglutide, semaglutide)\n* Pregnancy or planned pregnancy in the next 12 months. We will ask WOCBP about the possibility of pregnancy at the time of screening and if so, then pregnancy testing will be offered. If testing is declined in this instance, then they will be excluded from the study.\n* Women who are breastfeeding\n* Severe renal impairment (eGFR\\<30mL/min1.73m2)\n* Known history of allergy or hypersensitivity to dapagliflozin\n\nExclusion for optional MRI portion of the protocol:\n\n\\- Any contraindication to MRI'}, 'identificationModule': {'nctId': 'NCT06907251', 'acronym': 'DALCO', 'briefTitle': 'Dapagliflozin for Long COVID Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Heart Institute Research Corporation'}, 'officialTitle': 'Dapagliflozin for Long COVID Syndrome', 'orgStudyIdInfo': {'id': '2024OCT9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': 'Participants will receive 10mg dapagliflozin orally for 12 months', 'interventionNames': ['Drug: Dapagliflozin (DAPA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a placebo once daily for 12 months.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dapagliflozin (DAPA)', 'type': 'DRUG', 'description': 'Dapagliflozin 10mg orally once a day for 12 months', 'armGroupLabels': ['Interventional']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive a matching placebo taken once daily by mouth for 12 months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Poppy MacPhee', 'role': 'CONTACT', 'email': 'pmacphee@ottawaheart.ca', 'phone': '6136967000', 'phoneExt': '14646'}, {'name': 'Ian Paterson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'centralContacts': [{'name': 'Poppy Dr. Ian Paterson', 'role': 'CONTACT', 'email': 'dpaterson@ottawaheart.ca', 'phone': '1-613-696-7000'}, {'name': 'Poppy MacPhee', 'role': 'CONTACT', 'email': 'pmacphee@ottawaheart.ca', 'phone': '6136967000', 'phoneExt': '14646'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}