Health TrialsbyHealthPanel

Dapagliflozin for Long COVID Syndrome

ConditionsCOVID - 19Long COVID SyndromeSARS CoV-2
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation

About 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 does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin (DAPA)

    Drug

    Dapagliflozin 10mg orally once a day for 12 months

  • Placebo

    Drug

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

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: InterventionalExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

Incident diabetes

New diagnosis of diabetes mellitus (fasting glucose \>7.0 mmol/L. HbA!c \>6.5%, new prescription of diabetes pharmacotherapy)

Time frame
12 months
2

Cardiovascular Event

Cardiovascular event - atrial fibrillation, ventricular tachycardia/fibrillation, acute coronary syndrome, heart failure, transient ischemic attack, stroke, cardiovascular death

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Heart Institute Research Corporation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: