Dapagliflozin for Long COVID

(DALCO Trial)

Overseen By Poppy MacPhee

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ottawa Heart Institute Research Corporation

Must not be taking: Glucagon-like peptide-1 agonists

Disqualifiers: Diabetes, Heart failure, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether dapagliflozin, a medication, can help alleviate long COVID symptoms. Participants will receive either dapagliflozin or a placebo for 12 months to assess symptom improvement. It is suitable for individuals with new or ongoing symptoms at least 12 weeks after a COVID-19 infection. Those with confirmed COVID-19, either by test or diagnosis, and experiencing lingering symptoms may qualify for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering a chance to contribute to potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on weight loss treatment with certain medications like liraglutide or semaglutide, you cannot participate in the trial.

Is there any evidence suggesting that dapagliflozin is likely to be safe for humans?

Studies have shown that dapagliflozin is generally safe for patients, even during COVID-19. Research indicates that starting dapagliflozin in patients hospitalized with COVID-19 did not cause major safety issues, regardless of type 2 diabetes status. This suggests the drug is safe in these situations. Additionally, using dapagliflozin before contracting COVID-19 was not linked to a higher risk of severe outcomes, such as hospitalization or intensive care. These findings suggest that dapagliflozin is safe and generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for long COVID?

Unlike standard treatments for Long COVID, which often focus on alleviating individual symptoms like fatigue or cognitive issues, dapagliflozin targets a different mechanism. Dapagliflozin is a type of medication known as an SGLT2 inhibitor, primarily used to manage blood sugar levels in diabetes patients. Researchers are excited about its potential for Long COVID because it may help reduce inflammation and improve heart and kidney function, which are often affected in Long COVID patients. These properties offer a new approach that could address multiple aspects of Long COVID simultaneously, rather than targeting symptoms individually.

What evidence suggests that dapagliflozin might be an effective treatment for long COVID?

Research has shown that dapagliflozin has been safely used in people hospitalized with severe COVID-19. It did not cause longer hospital stays, more ICU admissions, or higher death rates. However, some studies suggest it might slightly increase the risk of contracting COVID-19. Despite this, it is generally well tolerated and considered safe. In this trial, participants in the interventional arm will receive dapagliflozin, which helps the body eliminate extra sugar through urine, potentially improving outcomes in people with COVID-19. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing long-term symptoms after COVID-19, known as Long COVID Syndrome. Specific details about who can join are not provided, but typically participants would need to meet certain health criteria.

Inclusion Criteria

I have tested positive for COVID-19 or was diagnosed with it by a doctor.

I have had symptoms for over 8 weeks that can't be explained by another condition.

I am willing to use effective birth control during the study.

Exclusion Criteria

Known history of allergy or hypersensitivity to dapagliflozin

Exclusion for optional MRI portion of the protocol: Any contraindication to MRI

Women who are breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dapagliflozin or placebo daily for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Dapagliflozin

Trial Overview The study is testing the effectiveness of a medication called Dapagliflozin in treating Long COVID Syndrome. Participants will be randomly assigned to receive either Dapagliflozin or a placebo for one year.

How Is the Trial Designed?

Group I: Interventional Experimental Treatment 1 Intervention

Participants will receive 10mg dapagliflozin orally for 12 months

Group II: Placebo Placebo Group 1 Intervention

Participants will receive a placebo once daily for 12 months.

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Published Research Related to This Trial

Dapagliflozin significantly improved blood sugar control in patients with type 2 diabetes who were not adequately managed with metformin and sulfonylurea, with a notable reduction in HbA1c levels and a higher percentage of patients achieving target glycemic response compared to placebo.

The treatment was well tolerated over 24 weeks, although it was associated with increased risks of hypoglycemia and genital infections compared to placebo, indicating the need for monitoring these side effects during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial. Matthaei, S., Bowering, K., Rohwedder, K., et al.[2022]

Dapagliflozin has been shown to be effective for up to 4 years in improving glycemic control, reducing blood pressure, and aiding weight loss in patients with type 2 diabetes, whether used alone or with other diabetes medications.

The long-term safety profile of dapagliflozin is favorable, with no significant increase in adverse events over time, and it is safe for use in patients with cardiovascular disease, mild renal impairment, and elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durability of response to dapagliflozin: a review of long-term efficacy and safety. Jabbour, S.[2022]

Dapagliflozin is an effective treatment for type 2 diabetes, showing noninferiority to metformin and glimepiride in clinical trials involving 9 studies, indicating it can be a reliable option for patients.

While generally safe, dapagliflozin is associated with an increased risk of urinary infections and other side effects, suggesting it may be best used as an add-on therapy for patients not adequately controlled on other diabetes medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin for the Treatment of Type 2 Diabetes Mellitus. Aylsworth, A., Dean, Z., VanNorman, C., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10477113/

Effect of dapagliflozin on COVID-19 infection and risk ... Use of dapagliflozin prior to SARS-CoV-2 infection was not associated with an increased risk of hospitalization, ICU admission, mortality or ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04350593

Dapagliflozin in Respiratory Failure in Patients With COVID ... Patients will be treated for 30 days, with either dapagliflozin 10 milligrams daily or placebo, each to be given in addition to the usual standard of care in ...

3. cardiab.biomedcentral.com cardiab.biomedcentral.com/articles/10.1186/s12933-025-02875-6

Efficacy and safety of dapagliflozin in patients hospitalized ... Initiating dapagliflozin in patients hospitalized for acute COVID-19 was well tolerated and safe, irrespective of T2D status. Serum biomarker ...

4. academic.oup.com academic.oup.com/jac/article-pdf/78/9/2335/51779543/dkad241.pdf

Effect of dapagliflozin on COVID-19 infection and risk of ... The use of dapagliflozin appeared to increase the risk of susceptibility to infection (COVID-19+) by 30% (aOR 1.31; 95% CI 1.05–1.62; P = 0.015 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666970625000216

Sodium-glucose cotransporter 2 Inhibitors and COVID-19 ... The objective of this study was to assess the risk of SARS-CoV-2 infection and poor COVID-19-related outcomes associated with SGLT-2i use in patients with type ...