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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.
Details
| Lead sponsor | Mount Sinai Hospital, Canada |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 118 |
| Start date | 2025-01-03 |
| Completion | 2027-01 |
Conditions
- SARS CoV-2 Post-Acute Sequelae
Interventions
- Nirmatrelvir/ritonavir
- Remdesivir
Primary outcomes
- Recruitment rate — From participant screening to enrolment
Recruitment rate, defined as the proportion of eligible people who consent and are randomized into the pilot trial, which will inform the feasibility of a full scale trial. - Post-acute sequelae of COVID-19 (PASC) — From enrolment to end of follow up at 1 year
Event rate of PASC at 1 year (specifically newly developed or worsening: stroke, heart failure, venous thromboembolism, diabetes or death)
Countries
Canada