Impact of Paxlovid on in-hospital outcomes and post-COVID-19 condition in adult patients infected with SARS-CoV-2 Omicron variant: A non-randomized controlled clinical trial

Abstract

Background: Nirmatrelvir plus ritonavir (Paxlovid) have been used in the treatment of adult patients with mild-to-moderate coronavirus disease 2019 (COVID-19). This study aimed to evaluate the impact of Paxlovid on in-hospital outcomes and post-COVID-19 condition in Chinese adult patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant. Methods: This non-randomized clinical controlled trial recruited patients infected with SARS-CoV-2 Omicron variant from the designated hospital for treating COVID-19 between November 5 and November 28, 2022, in Shijiazhuang, China. Participants were administered Paxlovid (300 mg of nirmatrelvir and 100 mg of ritonavir orally) or standard treatment. The primary outcome was the nucleic acid shedding time and post-COVID-19 condition. Results: A total of 320 patients infected with SARS-CoV-2 Omicron variant were included, with mean age of 29.10 ± 7.34 years old. Two hundred patients received Paxlovid. Compared to patients in the standard treatment group, those in Paxlovid group had a significantly shorter nucleic acid shedding time (3.26 ± 1.80 vs 7.75 ± 3.68 days, P < .001), shorter days until negative swab test (1.74 ± 1.15 vs 5.33 ± 2.91, P < .001), shorter days of first symptoms resolution (4.86 ± 1.62 vs 7.45 ± 2.63, P < .001), higher in nucleic acid test negative rate within 3 days [138 (70.77%) vs 14 (11.67%), P < .001], higher negative rate within 5 days [174 (89.23%) vs 26 (21.67%), P < .001], negative rate within 7 days [185 (94.87%) vs 78 (65.00%), P < .001], and were less likely to have post-COVID-19 condition [32 (18.60%) vs 30 (31.57%), P = .016]. There was no significant difference in duration of post-COVID-19 condition (43.00 ± 26.00 vs 49.00 ± 26.34 days, P = .354) between the 2 groups. Conclusion: Compared to standard treatment, Paxlovid significantly reduced nucleic acid shedding time, days until negative swab test, and days of first symptoms resolution, as well as improved nucleic acid test negative rate and post-COVID-19 condition.