Evaluating antiviral treatments to prevent long-term heart issues after COVID-19
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
This study is testing whether antiviral treatments like Paxlovid and Remdesivir can help prevent heart problems in adults who are hospitalized with COVID-19.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mount Sinai Hospital, Canada Academic / other |
| Locations | 4 sites (Kingston, Ontario and 3 other locations) |
| Trial ID | NCT06792214 on ClinicalTrials.gov |
What this trial studies
The DEFEND trial aims to assess the effectiveness of Paxlovid and Remdesivir in preventing cardiovascular complications in hospitalized adults who test positive for SARS-CoV-2. This pilot study will help determine the feasibility of a larger multicenter trial by estimating recruitment rates and validating hospital-based outcome measures. Participants aged 18 and older will be enrolled from four hospitals in Ontario, and the study will follow a double-blind, randomized, placebo-controlled design. The trial will also track the occurrence of serious cardiovascular events within one year following treatment.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults aged 18 and older with a positive PCR test for SARS-CoV-2.
Not a fit: Patients with severe allergies to the study medications or those requiring supplemental oxygen will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of long-term cardiovascular issues in COVID-19 survivors.
How similar studies have performed: This approach is novel, as it is the first clinical trial specifically targeting cardiovascular outcomes following COVID-19.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kingston, Ontario and 3 other locations
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (Not_yet_recruiting)
- Niagara Health System — St. Catharines, Ontario, Canada (Not_yet_recruiting)
- Mount Sinai Hospital, Sinai Health System — Toronto, Ontario, Canada (Recruiting)
- St. Joseph's Health Centre, Unity Health Toronto — Toronto, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: Dr. Kieran Quinn
- Email: kieran.quinn@mail.utoronto.ca
- Phone: 416-843-8403
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.