RecruitingPhase 4

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

Canada118 participantsStarted 2025-01-03

Plain-language summary

The DEFEND trial will be the world's first clinical trial to study the effectiveness of Paxlovid or Veklury in the prevention of cardiovascular post-acute sequelae of SARS-CoV-2 among hospitalized adults. Additionally, this pilot study will inform the design and conduct of a future full-scale multi-centre trial by testing the feasibility and accuracy of this study design.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≥18 years old * Positive PCR test for SARS-CoV-2 within 5 days of admission to hospital * Normoxic (not receiving supplemental oxygen) * Able to provide informed written consent (or, if patient is unable, have substitute decision maker available) Exclusion Criteria: * Absolute contraindications to Paxlovid or Veklury (any of the following): Severe allergy to Paxlovid or Veklury (e.g. anaphylaxis), co-administration with drugs highly dependent on CYP3A for clearance, co-administration with potent CYP3A inducers * Exposure to Paxlovid or Veklury within previous 14 days; * Receiving supplemental oxygen; * Known positive SARS-CoV-2 PCR or rapid antigen test 5-90 days prior to admission; * Limited life expectancy estimated to be ≤3 months; * Pregnant and breastfeeding women

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment rate

Timeframe: From participant screening to enrolment

Post-acute sequelae of COVID-19 (PASC)

Timeframe: From enrolment to end of follow up at 1 year

Trial details

NCT IDNCT06792214

SponsorMount Sinai Hospital, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01

Contact for this trial

Dr. Kieran Quinn

416-843-8403 kieran.quinn@mail.utoronto.ca

View on ClinicalTrials.gov More SARS CoV-2 Post-Acute Sequelae trials