The COVID-19 antiviral studies are evaluating the safety and effectiveness of the study medicine, PAXLOVIDTM, which is given orally. PAXLOVIDTM is a combination of the medicines nirmatrelvir and ritonavir. Nirmatrelvir is intended to reduce SARS-CoV-2 virus, thereby reducing the duration and severity of symptoms and the risk of hospitalization and death in SARS-CoV-2 infected patients. Ritonavir is a medication to boost the absorption of the study drug, nirmatrelvir.
PAXLOVIDTM 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 PAXLOVIDTM were less likely to be hospitalized or die from COVID-19 compared to participants who received a placebo (medicine with no active ingredient).
PAXLOVIDTM has not been approved but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The emergency use of PAXLOVIDTM is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner.