What this Trial Is About

Researchers are evaluating the effectiveness of the antiviral drugs Paxlovid and Veklury in preventing long-term cardiovascular complications following COVID-19 infection in hospitalized adults. This is a phase 4, multicenter, double-blind, randomized placebo-controlled pilot trial called DEFEND. The study aims to assess the feasibility of recruitment and the accuracy of hospital outcome measures, focusing on events such as stroke, heart failure, venous thromboembolism, diabetes, or death within one year. Participants aged 18 and older who test positive for SARS-CoV-2 upon hospital admission and meet eligibility criteria will be randomly assigned to receive either Paxlovid orally twice daily for 5 days, Veklury intravenously once daily for 5 days, or a matching placebo, all alongside standard care. The trial will enroll about 118 participants across four hospitals in Ontario over a 12-month period, followed by a 12-month follow-up to monitor outcomes. During the study, participants will undergo monitoring for cardiovascular events and other health outcomes through hospital data and follow-up assessments. Researchers will track recruitment rates and evaluate the incidence of post-acute sequelae of COVID-19 over one year. The data collected will help design and conduct a larger future trial and inform clinical practice regarding antiviral use in this patient population.

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