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
SARS CoV-2 Post-Acute SequelaeThe 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.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
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
Study Location
St. Joseph's Health Centre, Unity Health Toronto
St. Joseph's Health Centre, Unity Health TorontoToronto, Ontario
Canada
Contact Study Team
Mount Sinai Hospital, Sinai Health System
Mount Sinai Hospital, Sinai Health SystemToronto, Ontario
Canada
Contact Study Team
Kingston Health Sciences Centre
Kingston Health Sciences CentreKingston, Ontario
Canada
Contact Study Team
Niagara Health System
Niagara Health SystemSt. Catharines, Ontario
Canada
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- Study Sponsored By
- Mount Sinai Hospital, Canada
- Participants Required
- More Information
- Study ID:
NCT06792214