Status:
NOT_YET_RECRUITING
Dapagliflozin for Long COVID Syndrome
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
COVID - 19
Long COVID Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, placebo-controlled study. Patients with long COVID will be randomized to receive dapagliflozin or placebo for 12 months.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 18 years of age or older and willing and able to provide informed consent
- 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
- History of diabetes
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06907251
Start Date
June 1 2025
End Date
June 30 2029
Last Update
April 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7