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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMount Sinai Hospital, Canada

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

118 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mount Sinai Hospital, Canada

Lead sponsor

Unity Health Toronto

Collaborator

Kingston Health Sciences Centre

Collaborator

Niagara Health System

Collaborator