Studying Paxlovid and Veklury to Prevent Long-Term Heart Problems After COVID-19 in Hospitalized Adults

What this Trial Is About

Researchers are evaluating the effectiveness of two antiviral drugs, Paxlovid and Veklury, in preventing long-term cardiovascular problems following COVID-19 among hospitalized adults. This study, called the DEFEND trial, will be the first of its kind to focus on cardiovascular post-acute sequelae of SARS-CoV-2 in this patient group. It is a pilot, randomized, placebo-controlled trial designed to also help plan a larger future study by testing recruitment feasibility and accuracy of hospital outcome data. Participants will be randomly assigned to receive either Paxlovid orally twice daily for 5 days or Veklury intravenously once daily for 5 days, alongside standard care, or a matching placebo on the same schedule. The trial will enroll adults aged 18 or older who have tested positive for SARS-CoV-2 within 5 days of hospital admission and are not requiring supplemental oxygen. The study will recruit about 118 participants across four hospitals in Ontario, followed by a 12-month observation period after treatment. During the study, researchers will monitor participants from the time of screening through enrollment and track major cardiovascular events such as stroke, heart failure, venous thromboembolism, diabetes, or death within one year. They will also validate hospital data accuracy, assess reinfection, ICU admission, and drug safety within 90 days of the initial COVID-19 test. The trial includes thorough follow-up and safety monitoring over the full year to understand the long-term cardiovascular outcomes related to COVID-19 and the potential preventive effects of the antiviral treatments.

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