Dapagliflozin for Long COVID Syndrome

Phase 3

Not yet recruiting

• Conditions: COVID - 19; Long COVID Syndrome
• Interventions: Drug: Dapagliflozin (DAPA); Drug: Placebo

• Registration Number: NCT06907251
• Lead Sponsor: Ottawa Heart Institute Research Corporation

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 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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Study Start: 2025-06-01
• Primary Completion: 2028-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	Dapagliflozin (DAPA)	Participants will receive 10mg dapagliflozin orally for 12 months
Placebo	Placebo	Participants will receive a placebo once daily for 12 months.

Primary Outcome Measures

Name	Time	Method
6 month change in EQ-5D derived utility score.	6 months	The 6 month change in EQ-5D derived utility score will be compared between the dapagliflozin and placebo arms within a multiple regression model.

Secondary Outcome Measures

Name	Time	Method
Incident diabetes	12 months	New diagnosis of diabetes mellitus (fasting glucose \>7.0 mmol/L. HbA!c \>6.5%, new prescription of diabetes pharmacotherapy)
Cardiovascular Event	12 months	Cardiovascular event - atrial fibrillation, ventricular tachycardia/fibrillation, acute coronary syndrome, heart failure, transient ischemic attack, stroke, cardiovascular death

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada