This is a randomized, placebo-controlled study. Patients with long COVID will berandomized 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.
Drug: Dapagliflozin (DAPA)
Dapagliflozin 10mg orally once a day for 12 months
Drug: Placebo
Participants will receive a matching placebo taken once daily by mouth for 12 months.
Inclusion Criteria:
- 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 Criteria:
- 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
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Investigator: Poppy MacPhee
Contact: 6136967000
pmacphee@ottawaheart.ca
Poppy Dr. Ian Paterson
1-613-696-7000
dpaterson@ottawaheart.ca
Poppy MacPhee
6136967000 - 14646
pmacphee@ottawaheart.ca
Not Provided