About this 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.
Eligibility criteria
Qualifiers
≥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)
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Nirmatrelvir/ritonavir
- Remdesivir
Treatment groups
Sponsors and collaborators
Mount Sinai Hospital, Canada
Lead sponsor
Unity Health Toronto
Collaborator
Kingston Health Sciences Centre
Collaborator
Niagara Health System
Collaborator