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Prevention study for SARS CoV-2 Post-Acute Sequelae
Official title 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
ClinicalTrials.gov ID: NCT06792214
What this study is testing
What is Nirmatrelvir/ritonavir?
Nirmatrelvir/ritonavir is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for sars cov-2 post-acute sequelae.
Also referred to as Paxlovid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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)
You likely can't join if
- Absolute contraindications to Paxlovid or Veklury (any of the following): Severe allergy to Paxlovid or Veklury (e.g. anaphylaxis), co-administration...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kingston, Ontario, Canada
- St. Catharines, Ontario, Canada
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kingston, Ontario, Canada; St. Catharines, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.