RecruitingPHASE4INTERVENTIONAL

Antiviral Strategies in the Prevention of Long-term Cardiovascular Outcomes Following COVID-19: The paxloviD/Remdesivir Effectiveness For the prEvention of loNg coviD Clinical Trial

The DEFEND trial is investigating if common antiviral treatments, Paxlovid or Veklury (also known as nirmatrelvir/ritonavir and remdesivir), can prevent long-term heart and blood vessel problems after someone has been in hospital with COVID-19. This is a pilot study, meaning it's a smaller first step to see if the idea works and to help plan a larger study later on. The researchers want to find out if these medications can stop new cases of conditions like stroke or heart failure, or make existing problems worse, in the year following a COVID-19 hospitalisation. It's hoped that finding effective ways to treat COVID-19 early could reduce the number of people experiencing ongoing health issues.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Mount Sinai Hospital, Canada

Enrolment target

118

Start

03 Jan 2025

Estimated completion

01 Jan 2027

SARS CoV-2 Post-Acute Sequelae

What is this study about?

The DEFEND study is looking into a really important question: can we use existing medicines, Paxlovid or Veklury (two antiviral drugs), to stop people from developing serious heart and blood vessel problems after they've been in hospital with COVID-19? We know that some people who get COVID-19 can experience long-term health issues, sometimes called 'long COVID'. This study is specifically focused on problems like heart conditions, strokes, blot clots, or developing diabetes after a COVID-19 infection.

This is a 'pilot' study, which means it's a smaller, early version of a trial. Think of it as a practice run to make sure everything works well before a much larger study is carried out. The main aim is to see if it's practical to conduct a bigger trial and to check if the study's design is accurate. They want to find out if enough people would be willing to take part and how often these heart-related issues occur in the year after COVID-19.

Ultimately, the goal is to find out if giving these antiviral treatments early in a hospital stay can help protect people from these lasting health problems. If this pilot study is successful, it will help researchers design a bigger study that could one day change how we treat COVID-19 to reduce its long-term effects on people's health.

Key takeaways

This study looks at whether specific COVID-19 medicines prevent long-term heart problems.
It's a small, initial study to help plan a larger trial in the future.
Participants will receive either an antiviral medicine or a dummy treatment for 5 days.
Neither you nor your doctor will know which treatment you are receiving.
Your health will be monitored for up to a year after your hospital stay.

Who may be eligible?

This study is looking for adults aged 18 or older who have tested positive for COVID-19 within five days of being admitted to one of the four participating hospitals in Ontario. You should also be breathing normally without needing extra oxygen.

However, you won't be able to join if you have a severe allergy to Paxlovid or Veklury, or if you're taking certain medications that don't mix well with these antivirals. You also can't have taken Paxlovid or Veklury in the last two weeks, or if you had a COVID-19 infection 5 to 90 days before your current hospital stay.

Sadly, the study isn't suitable for pregnant or breastfeeding women, or if doctors expect you to live for less than three months. The aim is to include as many people as possible who might benefit from the treatment, so the rules are quite broad for those who can join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Did you test positive for COVID-19 within 5 days of coming into hospital?
Are you breathing easily without needing extra oxygen?
Are you *not* pregnant or breastfeeding?
Have you *not* taken Paxlovid or Veklury in the last 14 days?
Do you *not* have a severe allergy to these medicines or take drugs that don't mix well with them?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you will be randomly assigned to one of two groups. One group will receive either Paxlovid (a tablet taken by mouth) or Veklury (given through a drip into your arm) once or twice a day for five days. The other group will receive a placebo – a dummy treatment that looks just like the real medicine but contains no active drug – for the same amount of time. You will also continue to receive your usual hospital care.

Neither you, your doctor, nor the study team will know whether you are receiving the active drug or the placebo; this is called 'double-blind'. The study will follow your health for up to one year to see if you develop any of the cardiovascular problems being studied. There will be no extra hospital visits beyond your normal medical care, as the researchers will use your hospital records to gather information.

Potential risks and benefits

Participating in this study might offer the potential benefit of reducing your risk of developing serious long-term heart and blood vessel problems after COVID-19, although we don't know for sure if the treatments will have this effect. There are always potential risks with any medicine, including side effects from Paxlovid or Veklury, or from taking a placebo if you are in that group. The medical team will monitor you closely for any issues. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your current or future medical care.

Locations (4)

Kingston Health Sciences Centre
Verified postcode
Kingston, Canada· Not yet recruiting
Niagara Health System
Verified postcode
St. Catharines, Canada· Not yet recruiting
Mount Sinai Hospital, Sinai Health System
Verified postcode
Toronto, Canada· Recruiting
St. Joseph's Health Centre, Unity Health Toronto
Verified postcode
Toronto, Canada· Not yet recruiting

Common questions

What exactly are Paxlovid and Veklury?

They are antiviral medicines used to treat COVID-19, especially in people who are at higher risk of becoming seriously ill.

What does a 'pilot study' mean?

It's a smaller, early version of a study used to test if the methods and plans work well before starting a much larger research project.

Will I know if I'm getting the real medicine or a dummy pill?

No, neither you nor your doctors will know. This is to make sure the results are as fair and accurate as possible.

How long will I be involved in the study?

You'll receive the study medicine for 5 days during your hospital stay, and then your health will be followed for up to one year using your medical records.

What kind of long-term problems are they looking for?

The study is focused on serious heart and blood vessel issues like stroke, heart failure, blood clots, or developing diabetes within a year after COVID-19.

How to find out more

Dr. Kieran Quinn

kieran.quinn@mail.utoronto.ca 416-843-8403 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.