Dapagliflozin for Long COVID Syndrome (DALCO)

University of Ottawa Heart Institute

Status and phase: Not yet enrolling; Phase 3

Conditions: Long COVID Syndrome; COVID - 19

Treatments: Drug: Dapagliflozin (DAPA); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06907251

2024OCT9

Details and patient eligibility

About

This is a randomized, placebo-controlled study. Patients with long COVID will be randomized to receive dapagliflozin or placebo for 12 months.

Full 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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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192 participants in 2 patient groups, including a placebo group

Interventional

Experimental group

Description:

Participants will receive 10mg dapagliflozin orally for 12 months

Treatment:

Drug: Dapagliflozin (DAPA)

Placebo

Placebo Comparator group

Description:

Participants will receive a placebo once daily for 12 months.

Treatment:

Drug: Placebo