PAXLOVIDTM is a combination of the medicines nirmatrelvir and ritonavir. PAXLOVID was studied in a previous clinical trial of non-hospitalized adults with symptomatic COVID-19 who had at least 1 risk factor for progressing to severe COVID-19. The results from that study showed that participants who received PAXLOVID were less likely to be hospitalized or die from COVID-19 compared to participants who received a placebo.
On December 22nd, 2021, the US FDA granted an Emergency Use Authorization of PAXLOVID for the treatment of mild to moderate COVID-19 in adults and children 12 years of age and older weighing at least 40 kg who are at high risk of developing severe COVID-19, including pregnant women. PAXLOVID is considered investigational in this study because it has not been studied in pregnant or breastfeeding women previously.