Effect of Paxlovid on Neurodevelopmental Disorder Diagnosis Outcomes in Offspring of Mothers Infected with SARS-Cov-2 during Pregnancy

The onset of the 2020 COVID-19 pandemic brought concern over the effects that this virus would have on pregnancy and fetal outcomes, specifically neurodevelopmental outcomes. Maternal immune activation (MIA), caused by infection during pregnancy, is known to result in neurodevelopmental disorder (NDD) diagnosis in offspring, typically autism spectrum disorder (ASD) and attention deficit/hyperactivity disorder (ADHD). This effect has already been observed in mothers who were infected with COVID-19 during pregnancy. However, in 2023, Paxlovid, the COVID-19 antiviral drug, became available to patients experiencing symptoms of the virus, including pregnant women. Consequently, this study seeks to determine whether the risk of an NDD diagnosis due to MIA decreases with Paxlovid use 3-5 days post-infection. In an observational cohort study, data will be collected on women who gave birth in the U.S. for one year, followed by data collection on their offspring for the first 18 years of life. Predicted results show differences between NDD diagnosis outcomes between offspring of mothers who were infected with COVID-19 and did not take Paxlovid (40% diagnosed) compared to those of mothers who were infected and did take Paxlovid (20% diagnosed). Additionally, increased risk of an NDD diagnosed in offspring of mothers who did not take Paxlovid is expected to be positively correlated with the progression of pregnancy of infection and with the severity of COVID-19 infection. Finally, predicted results will show that, compared to female offspring, male offspring are at a greater risk of an NDD diagnosis as a result of MIA from COVID-19 infection in the absence of Paxlovid use (45% diagnosis versus 35% diagnosis). Together, these predicted results point towards the efficacy of Paxlovid, both as a medication for COVID-19 infection and as a means to reduce the risk of an NDD diagnosis in offspring. Future research should investigate the effects that comorbidities and vaccination status have on these results.