Nirmatrelvir/ritonavir (Paxlovid) in the prevention of long-term cardiovascular outcomes: The paxloviD Effectiveness For the prEvention of loNg coviD (DEFEND) clinical trial.

The paxloviD Effectiveness For the prEvention of LoNg coviD (DEFEND) clinical trial will look to see if giving Paxlovid to people when they are first sick in hospital with COVID will lead to fewer deaths, heart problems, strokes, diabetes, or blood clots in the year afterwards. COVID's effects don't end when the infection does. Long COVID, also called Post-Acute Sequelae of COVID, causes a range of disabling symptoms, and serious health conditions. Paxlovid is a mixture of 2 antiviral medications already used to prevent severe illness as a result of COVID infection. We want to see if Paxlovid also prevents long COVID. No one knows if Paxlovid will do this, which is why we need to study it in a clinical trial. We will study adults who are sick enough to need admission to hospital and who test positive for COVID. We won't include people who are so sick with COVID that they need other drugs like steroids. This lets us look at only the effect of Paxlovid in the prevention of long COVID. This trial is called a pilot. It's focus is studying if we are able to complete a larger future trial. When a patient agrees to be participate, they will be randomly get Paxlovid or pills that look and taste the same but do not contain any medication (called placebo). We will check how many people successfully participated in the pilot over 1 year. After people receive treatment, we will check if any of them died or were newly diagnosed with heart problems, stroke, diabetes, or blood clots in the year afterwards. If people already had these health issues when they were hospitalized, we will check if any of these health issues got worse in the year after they had COVID. If we can successfully include enough people in the pilot, we can study if these health problems are reduced in people who got Paxlovid compared to those who did not. This information could change lives, change how COVID is treated, and change the odds of getting long COVID.