NCT06792214RecruitingPhase 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
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
Source: ClinicalTrials.gov · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- First submitted
- 23 Dec 2024
- Start date
- 3 Jan 2025
- Primary completion date
- Jan 2026
- Lead sponsor
- Mount Sinai Hospital, Canada
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06792214
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 118
- From 3 Jan 2025 to the primary completion date, Jan 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Lab values
- 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
Other
- Limited life expectancy estimated to be ≤3 months;
- Pregnant and breastfeeding women
Who the study is looking for
- ≥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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kingston Health Sciences Centre Coordinator of this site? Confirm its status | Kingston | Canada | Not yet recruiting |
| Niagara Health System Coordinator of this site? Confirm its status | St. Catharines | Canada | Not yet recruiting |
| Mount Sinai Hospital, Sinai Health System Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| St. Joseph's Health Centre, Unity Health Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.