Dapagliflozin for Long COVID Syndrome

NCT06907251 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2024OCT9
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID - 19; Long COVID Syndrome; SARS CoV-2

Keywords

Covid-19; Long Covid syndrome; sars cov-2

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• Incident diabetes

  12 months

• Cardiovascular Event

  12 months

Study Arms (2)

Interventional

EXPERIMENTAL

Participants will receive 10mg dapagliflozin orally for 12 months

Drug: Dapagliflozin (DAPA)

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo once daily for 12 months.

Drug: Placebo

Interventions

Dapagliflozin (DAPA) DRUG

Dapagliflozin 10mg orally once a day for 12 months

Interventional

Placebo DRUG

Participants will receive a matching placebo taken once daily by mouth for 12 months.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• \- Any contraindication to MRI

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

COVID-19

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Poppy Dr. Ian Paterson

CONTACT

1-613-696-7000; dpaterson@ottawaheart.ca

Poppy MacPhee

CONTACT

6136967000; pmacphee@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 2, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)