Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
192 participants
INTERVENTIONAL
2025-06-01
2029-06-30
Brief Summary
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Detailed Description
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Eligible 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Interventional
Participants will receive 10mg dapagliflozin orally for 12 months
Dapagliflozin (DAPA)
Dapagliflozin 10mg orally once a day for 12 months
Placebo
Participants will receive a placebo once daily for 12 months.
Placebo
Participants will receive a matching placebo taken once daily by mouth for 12 months.
Interventions
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Dapagliflozin (DAPA)
Dapagliflozin 10mg orally once a day for 12 months
Placebo
Participants will receive a matching placebo taken once daily by mouth for 12 months.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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).
* 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.
Exclusion Criteria
* Prior heart failure
* Weight loss treatment with glucagon-like peptide-1 receptor agonists (e.g. liraglutide, semaglutide)
* 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.
* Women who are breastfeeding
* Severe renal impairment (eGFR\<30mL/min1.73m2)
* Known history of allergy or hypersensitivity to dapagliflozin
Exclusion for optional MRI portion of the protocol:
\- Any contraindication to MRI
18 Years
ALL
No
Sponsors
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Ottawa Heart Institute Research Corporation
OTHER
Responsible Party
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Locations
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University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024OCT9
Identifier Type: -
Identifier Source: org_study_id
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