192 Participants Needed

Dapagliflozin for Long COVID

(DALCO Trial)

PD
PM
Overseen ByPoppy MacPhee
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Ottawa Heart Institute Research Corporation
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

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.

What data supports the effectiveness of the drug Dapagliflozin for Long COVID?

Dapagliflozin has shown protective benefits for the heart and kidneys in patients with COVID-19, which might help with organ protection during acute illness. Additionally, it is effective in managing type 2 diabetes by lowering blood sugar levels and reducing body weight.12345

Is dapagliflozin generally safe for humans?

Dapagliflozin has been studied for safety in people with type 2 diabetes, showing a good safety profile in both short-term and long-term studies. It has been evaluated in various settings, including real-life clinical environments, and is generally considered safe for use in humans.46789

How does the drug dapagliflozin differ from other treatments for Long COVID?

Dapagliflozin is unique because it is originally a diabetes medication that works by helping the kidneys remove sugar from the body through urine, which is different from other treatments that might focus on directly addressing symptoms of Long COVID. There are no standard treatments for Long COVID, making dapagliflozin's novel mechanism of action potentially beneficial in managing this condition.3581011

What is the purpose of this trial?

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

Eligibility Criteria

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
See 5 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionalExperimental Treatment1 Intervention
Participants will receive 10mg dapagliflozin orally for 12 months
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a placebo once daily for 12 months.

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Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+

Findings from Research

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.
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 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.
Dapagliflozin for the Treatment of Type 2 Diabetes Mellitus.Aylsworth, A., Dean, Z., VanNorman, C., et al.[2019]
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.
Durability of response to dapagliflozin: a review of long-term efficacy and safety.Jabbour, S.[2022]

References

Dapagliflozin in patients with cardiometabolic risk factors hospitalised with COVID-19 (DARE-19): a randomised, double-blind, placebo-controlled, phase 3 trial. [2022]
Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. [2023]
Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial. [2022]
Dapagliflozin: The outcome of use as add-on therapy in real-life clinical setting -An Audit. [2022]
Dapagliflozin: a review of its use in type 2 diabetes mellitus. [2021]
Safety of dapagliflozin in a broad population of patients with type 2 diabetes: Analyses from the DECLARE-TIMI 58 study. [2021]
Dapagliflozin for the Treatment of Type 2 Diabetes Mellitus. [2019]
Durability of response to dapagliflozin: a review of long-term efficacy and safety. [2022]
Long-Term Safety of Dapagliflozin in Older Patients with Type 2 Diabetes Mellitus: A Pooled Analysis of Phase IIb/III Studies. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Dapagliflozin as monotherapy or combination therapy in Japanese patients with type 2 diabetes: an open-label study. [2022]
Efficacy and safety of dapagliflozin as a monotherapy for type 2 diabetes mellitus in Japanese patients with inadequate glycaemic control: a phase II multicentre, randomized, double-blind, placebo-controlled trial. [2022]
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