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
Recruiting now · Phase 4
Conditions studied: SARS CoV-2 Post-Acute Sequelae
In brief
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.
Key facts
- Study ID
- NCT06792214
- Run by
- Mount Sinai Hospital, Canada
- People needed
- 118
- Starts
- 2025-01-03
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2025-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥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)
You may not qualify if…
- 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
Where it is running
- Mount Sinai Hospital, Sinai Health System — Toronto, Ontario, Canada (enrolling)
- Kingston Health Sciences Centre — Kingston, Ontario, Canada
- Niagara Health System — St. Catharines, Ontario, Canada
- St. Joseph's Health Centre, Unity Health Toronto — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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