Testing Paxlovid and Veklury to prevent long-term heart problems after COVID-19
Tests two COVID-19 antiviral drugs for preventing later heart complications in hospitalized adults.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Kingston, St. Catharines, and Toronto, CanadaSee the 4 sites
- Phase
- Phase 4
Where in Canada
- Kingston Health Sciences CentreKingston, CanadaNot yet recruiting
- Niagara Health SystemSt. Catharines, CanadaNot yet recruiting
- Mount Sinai Hospital, Sinai Health SystemToronto, CanadaTaking people
- St. Joseph's Health Centre, Unity Health TorontoToronto, CanadaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mount Sinai Hospital, Canada
- Trial code
- NCT06792214
- Record updated
- 24 January 2025
- Original description
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.Read full original descriptionShow less
Antiviral Strategies in the Prevention of Long-term Cardiovascular Outcomes Following COVID-19: The paxloviD/Remdesivir Effectiveness For the prEvention of loNg coviD (DEFEND) Clinical Trial
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.
Inclusion: ≥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: 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; 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; Limited life expectancy estimated to be ≤3 months; Pregnant and breastfeeding women.