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

DOI record: { "DOI": "10.1097/md.0000000000036714", "ISSN": [ "0025-7974", "1536-5964" ], "URL": "http://dx.doi.org/10.1097/MD.0000000000036714", "abstract": "<jats:sec>\n <jats:title>Background:</jats:title>\n <jats:p>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.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Methods:</jats:title>\n <jats:p>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.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Results:</jats:title>\n <jats:p>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, <jats:italic toggle=\"yes\">P</jats:italic> &lt; .001), shorter days until negative swab test (1.74 ± 1.15 vs 5.33 ± 2.91, <jats:italic toggle=\"yes\">P</jats:italic> &lt; .001), shorter days of first symptoms resolution (4.86 ± 1.62 vs 7.45 ± 2.63, <jats:italic toggle=\"yes\">P</jats:italic> &lt; .001), higher in nucleic acid test negative rate within 3 days [138 (70.77%) vs 14 (11.67%), <jats:italic toggle=\"yes\">P</jats:italic> &lt; .001], higher negative rate within 5 days [174 (89.23%) vs 26 (21.67%), <jats:italic toggle=\"yes\">P</jats:italic> &lt; .001], negative rate within 7 days [185 (94.87%) vs 78 (65.00%), <jats:italic toggle=\"yes\">P</jats:italic> &lt; .001], and were less likely to have post-COVID-19 condition [32 (18.60%) vs 30 (31.57%), <jats:italic toggle=\"yes\">P</jats:italic> = .016]. There was no significant difference in duration of post-COVID-19 condition (43.00 ± 26.00 vs 49.00 ± 26.34 days, <jats:italic toggle=\"yes\">P</jats:italic> = .354) between the 2 groups.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Conclusion:</jats:title>\n <jats:p>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.</jats:p>\n </jats:sec>", "author": [ { "affiliation": [ { "name": "Hebei University of Chinese Medicine, Shijiazhuang, China" }, { "name": "Shijiazhuang People’s Hospital, Shijiazhuang, China" } ], "family": "Xu", "given": "Jianchao", "sequence": "first" }, { "affiliation": [ { "name": "Hebei University of Chinese Medicine, Shijiazhuang, China" }, { "name": "The Traditional Chinese Medicine Hospital of Shijiazhuang, Shijiazhuang, China" } ], "family": "Song", "given": "Jinzhong", "sequence": "additional" }, { "affiliation": [ { "name": "Hebei Medical University, Shijiazhuang, China" } ], "family": "Xie", "given": "Ziyu", "sequence": "additional" }, { "affiliation": [ { "name": "Hebei General Hospital, Shijiazhuang, China" } ], "family": "Yang", "given": "Jie", "sequence": "additional" }, { "affiliation": [ { "name": "The Traditional Chinese Medicine Hospital of Shijiazhuang, Shijiazhuang, China" } ], "family": "Wu", "given": "Di", "sequence": "additional" }, { "affiliation": [ { "name": "Hebei Academy of Chinese Medical Sciences, Shijiazhuang, China" } ], "family": "Liu", "given": "Fengshuang", "sequence": "additional" }, { "affiliation": [ { "name": "School of Biological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK" } ], "family": "Zhao", "given": "Yinuo", "sequence": "additional" }, { "affiliation": [ { "name": "The Traditional Chinese Medicine Hospital of Shijiazhuang, Shijiazhuang, China" } ], "family": "Zang", "given": "Hongmin", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0003-1981-9297", "affiliation": [ { "name": "Hebei University of Chinese Medicine, Shijiazhuang, China" }, { "name": "Shijiazhuang People’s Hospital, Shijiazhuang, China" }, { "name": "North China University of Science and Technology, Tangshan, China." } ], "authenticated-orcid": false, "family": "Zhao", "given": "Yubin", "sequence": "additional" } ], "container-title": "Medicine", "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2023, 12, 22 ] ], "date-time": "2023-12-22T19:01:23Z", "timestamp": 1703271683000 }, "deposited": { "date-parts": [ [ 2023, 12, 22 ] ], "date-time": "2023-12-22T19:01:37Z", "timestamp": 1703271697000 }, "indexed": { "date-parts": [ [ 2023, 12, 23 ] ], "date-time": "2023-12-23T00:21:08Z", "timestamp": 1703290868783 }, "is-referenced-by-count": 0, "issue": "51", "issued": { "date-parts": [ [ 2023, 12, 22 ] ] }, 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"General Medicine" ], "subtitle": [], "title": "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", "type": "journal-article", "volume": "102" }