This is a randomized, placebo-controlled study. Patients with long COVID will be randomized to receive dapagliflozin or placebo for 12 months.
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). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
192
Dapagliflozin 10mg orally once a day for 12 months
Participants will receive a matching placebo taken once daily by mouth for 12 months.
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
6 month change in EQ-5D derived utility score.
The 6 month change in EQ-5D derived utility score will be compared between the dapagliflozin and placebo arms within a multiple regression model.
Time frame: 6 months
Incident diabetes
New diagnosis of diabetes mellitus (fasting glucose \>7.0 mmol/L. HbA!c \>6.5%, new prescription of diabetes pharmacotherapy)
Time frame: 12 months
Cardiovascular Event
Cardiovascular event - atrial fibrillation, ventricular tachycardia/fibrillation, acute coronary syndrome, heart failure, transient ischemic attack, stroke, cardiovascular death
Time frame: 12 months
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