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

{ 'indexed': { 'date-parts': [[2023, 12, 23]], 'date-time': '2023-12-23T00:21:08Z', 'timestamp': 1703290868783}, 'reference-count': 31, 'publisher': 'Ovid Technologies (Wolters Kluwer Health)', 'issue': '51', 'license': [ { 'start': { 'date-parts': [[2023, 12, 22]], 'date-time': '2023-12-22T00:00:00Z', 'timestamp': 1703203200000}, 'content-version': 'unspecified', 'delay-in-days': 0, 'URL': 'http://creativecommons.org/licenses/by/4.0/'}], 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'published-print': {'date-parts': [[2023, 12, 22]]}, '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\u2009mg of nirmatrelvir and 100\u2009mg 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\u2005±\u20057.34 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\u2005±\u20051.80 vs 7.75\u2005±\u2005' '3.68 days, <jats:italic toggle="yes">P</jats:italic>\u2005&lt;\u2005.001), shorter days until ' 'negative swab test (1.74\u2005±\u20051.15 vs 5.33\u2005±\u20052.91, <jats:italic ' 'toggle="yes">P</jats:italic>\u2005&lt;\u2005.001), shorter days of first symptoms resolution ' '(4.86\u2005±\u20051.62 vs 7.45\u2005±\u20052.63, <jats:italic ' 'toggle="yes">P</jats:italic>\u2005&lt;\u2005.001), higher in nucleic acid test negative rate ' 'within 3 days [138 (70.77%) vs 14 (11.67%), <jats:italic toggle="yes">P</jats:italic>\u2005' '&lt;\u2005.001], higher negative rate within 5 days [174 (89.23%) vs 26 (21.67%), ' '<jats:italic toggle="yes">P</jats:italic>\u2005&lt;\u2005.001], negative rate within 7 days ' '[185 (94.87%) vs 78 (65.00%), <jats:italic toggle="yes">P</jats:italic>\u2005&lt;\u2005.001], ' 'and were less likely to have post-COVID-19 condition [32 (18.60%) vs 30 (31.57%), ' '<jats:italic toggle="yes">P</jats:italic>\u2005=\u2005.016]. There was no significant ' 'difference in duration of post-COVID-19 condition (43.00\u2005±\u200526.00 vs 49.00\u2005' '±\u200526.34 days, <jats:italic toggle="yes">P</jats:italic>\u2005=\u2005.354) 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>', 'DOI': '10.1097/md.0000000000036714', 'type': 'journal-article', 'created': { 'date-parts': [[2023, 12, 22]], 'date-time': '2023-12-22T19:01:23Z', 'timestamp': 1703271683000}, 'page': 'e36714', 'source': 'Crossref', 'is-referenced-by-count': 0, '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', 'prefix': '10.1097', 'volume': '102', 'author': [ { 'given': 'Jianchao', 'family': 'Xu', 'sequence': 'first', 'affiliation': [ {'name': 'Hebei University of Chinese Medicine, Shijiazhuang, China'}, {'name': 'Shijiazhuang People’s Hospital, Shijiazhuang, China'}]}, { 'given': 'Jinzhong', 'family': 'Song', 'sequence': 'additional', 'affiliation': [ {'name': 'Hebei University of Chinese Medicine, Shijiazhuang, China'}, { 'name': 'The Traditional Chinese Medicine Hospital of Shijiazhuang, ' 'Shijiazhuang, China'}]}, { 'given': 'Ziyu', 'family': 'Xie', 'sequence': 'additional', 'affiliation': [{'name': 'Hebei Medical University, Shijiazhuang, China'}]}, { 'given': 'Jie', 'family': 'Yang', 'sequence': 'additional', 'affiliation': [{'name': 'Hebei General Hospital, Shijiazhuang, China'}]}, { 'given': 'Di', 'family': 'Wu', 'sequence': 'additional', 'affiliation': [ { 'name': 'The Traditional Chinese Medicine Hospital of Shijiazhuang, ' 'Shijiazhuang, China'}]}, { 'given': 'Fengshuang', 'family': 'Liu', 'sequence': 'additional', 'affiliation': [{'name': 'Hebei Academy of Chinese Medical Sciences, Shijiazhuang, China'}]}, { 'given': 'Yinuo', 'family': 'Zhao', 'sequence': 'additional', 'affiliation': [ { 'name': 'School of Biological Sciences, Faculty of Biology, Medicine and ' 'Health, The University of Manchester, Manchester, UK'}]}, { 'given': 'Hongmin', 'family': 'Zang', 'sequence': 'additional', 'affiliation': [ { 'name': 'The Traditional Chinese Medicine Hospital of Shijiazhuang, ' 'Shijiazhuang, China'}]}, { 'ORCID': 'http://orcid.org/0000-0003-1981-9297', 'authenticated-orcid': False, 'given': 'Yubin', 'family': 'Zhao', 'sequence': 'additional', '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.'}]}], 'member': '276', 'reference': [ { 'key': 'R1-20231222', 'first-page': '2012', 'article-title': 'Novel coronavirus 2019-nCoV: prevalence, biological and clinical ' 'characteristics comparison with SARS-CoV and MERS-CoV.', 'volume': '24', 'author': 'Meo', 'year': '2020', 'journal-title': 'Eur Rev Med Pharmacol Sci'}, { 'key': 'R2-20231222', 'doi-asserted-by': 'crossref', 'first-page': '1', 'DOI': '10.1007/s00199-019-01214-7', 'article-title': 'Infectious diseases, human capital and economic growth.', 'volume': '70', 'author': 'Goenka', 'year': '2020', 'journal-title': 'Econ Theory'}, { 'key': 'R4-20231222', 'doi-asserted-by': 'crossref', 'first-page': 'e28138', 'DOI': '10.1002/jmv.28138', 'article-title': 'The outbreak of SARS-CoV-2 Omicron lineages, immune escape, and vaccine ' 'effectivity.', 'volume': '95', 'author': 'Zhou', 'year': '2023', 'journal-title': 'J Med Virol'}, { 'key': 'R5-20231222', 'doi-asserted-by': 'crossref', 'first-page': '141', 'DOI': '10.1038/s41392-022-00997-x', 'article-title': 'SARS-CoV-2 Omicron variant: recent progress and future perspectives.', 'volume': '7', 'author': 'Fan', 'year': '2022', 'journal-title': 'Signal Transduct Target Ther'}, { 'key': 'R6-20231222', 'doi-asserted-by': 'crossref', 'first-page': '1627', 'DOI': '10.1002/jmv.27515', 'article-title': 'Omicron variant genome evolution and phylogenetics.', 'volume': '94', 'author': 'Kandeel', 'year': '2022', 'journal-title': 'J Med Virol'}, { 'key': 'R7-20231222', 'doi-asserted-by': 'crossref', 'first-page': '1551', 'DOI': '10.3390/v15071551', 'article-title': 'SARS-CoV-2 reinfections in health-care workers, 1 March 2020–31 January ' '2023.', 'volume': '15', 'author': 'Cegolon', 'year': '2023', 'journal-title': 'Viruses'}, { 'key': 'R8-20231222', 'doi-asserted-by': 'crossref', 'first-page': '337', 'DOI': '10.1080/22221751.2021.2022440', 'article-title': 'Omicron variant showed lower neutralizing sensitivity than other ' 'SARS-CoV-2 variants to immune sera elicited by vaccines after boost.', 'volume': '11', 'author': 'Ai', 'year': '2022', 'journal-title': 'Emerg Microbes Infect'}, { 'key': 'R9-20231222', 'doi-asserted-by': 'crossref', 'first-page': '202', 'DOI': '10.1016/j.cmi.2021.10.005', 'article-title': 'Comparing COVID-19 vaccines for their characteristics, efficacy and ' 'effectiveness against SARS-CoV-2 and variants of concern: a narrative ' 'review.', 'volume': '28', 'author': 'Fiolet', 'year': '2022', 'journal-title': 'Clin Microbiol Infect'}, { 'key': 'R10-20231222', 'doi-asserted-by': 'crossref', 'first-page': '721', 'DOI': '10.3390/ph16050721', 'article-title': 'Molnupiravir, nirmatrelvir/ritonavir, or sotrovimab for high-risk ' 'COVID-19 patients infected by the omicron variant: hospitalization, ' 'mortality, and time until negative swab test in real life.', 'volume': '16', 'author': 'Cegolon', 'year': '2023', 'journal-title': 'Pharmaceuticals (Basel)'}, { 'key': 'R11-20231222', 'doi-asserted-by': 'crossref', 'first-page': '1397', 'DOI': '10.1056/NEJMoa2118542', 'article-title': 'Oral nirmatrelvir for high-risk, nonhospitalized adults with Covid-19.', 'volume': '386', 'author': 'Hammond', 'year': '2022', 'journal-title': 'N Engl J Med'}, { 'key': 'R12-20231222', 'doi-asserted-by': 'crossref', 'first-page': '5349', 'DOI': '10.1021/acsomega.2c06384', 'article-title': 'Scalable inhibitors of the Nsp3-Nsp4 coupling in SARS-CoV-2.', 'volume': '8', 'author': 'Azizogli', 'year': '2023', 'journal-title': 'ACS Omega'}, { 'key': 'R13-20231222', 'doi-asserted-by': 'crossref', 'first-page': '1191', 'DOI': '10.1002/cpt.2646', 'article-title': 'Recommendations for the management of drug-drug interactions between ' 'the COVID-19 antiviral nirmatrelvir/ritonavir (Paxlovid) and ' 'comedications.', 'volume': '112', 'author': 'Marzolini', 'year': '2022', 'journal-title': 'Clin Pharmacol Ther'}, { 'key': 'R14-20231222', 'doi-asserted-by': 'crossref', 'first-page': 'e342', 'DOI': '10.1093/cid/ciac443', 'article-title': 'Effectiveness of Paxlovid in reducing severe coronavirus disease 2019 ' 'and mortality in high-risk patients.', 'volume': '76', 'author': 'Najjar-Debbiny', 'year': '2023', 'journal-title': 'Clin Infect Dis'}, { 'key': 'R15-20231222', 'doi-asserted-by': 'crossref', 'first-page': '516', 'DOI': '10.1080/07853890.2022.2034936', 'article-title': 'Efficacy and safety of three new oral antiviral treatment ' '(Molnupiravir, fluvoxamine and Paxlovid) for COVID-19: a meta-analysis.', 'volume': '54', 'author': 'Wen', 'year': '2022', 'journal-title': 'Ann Med'}, { 'key': 'R16-20231222', 'doi-asserted-by': 'crossref', 'first-page': '406', 'DOI': '10.1056/NEJMoa2208822', 'article-title': 'VV116 versus nirmatrelvir-ritonavir for oral treatment of Covid-19.', 'volume': '388', 'author': 'Cao', 'year': '2023', 'journal-title': 'N Engl J Med'}, { 'key': 'R17-20231222', 'doi-asserted-by': 'crossref', 'first-page': '66', 'DOI': '10.1016/j.jinf.2022.09.027', 'article-title': 'Efficacy and safety of Paxlovid for COVID-19:a meta-analysis.', 'volume': '86', 'author': 'Zheng', 'year': '2023', 'journal-title': 'J Infect'}, { 'key': 'R18-20231222', 'doi-asserted-by': 'crossref', 'first-page': 'e102', 'DOI': '10.1016/S1473-3099(21)00703-9', 'article-title': 'A clinical case definition of post-COVID-19 condition by a Delphi ' 'consensus.', 'volume': '22', 'author': 'Soriano', 'year': '2022', 'journal-title': 'Lancet Infect Dis'}, { 'key': 'R19-20231222', 'doi-asserted-by': 'crossref', 'first-page': '1045', 'DOI': '10.1056/NEJMc2206449', 'article-title': 'Rebound of SARS-CoV-2 infection after nirmatrelvir-ritonavir treatment.', 'volume': '387', 'author': 'Charness', 'year': '2022', 'journal-title': 'N Engl J Med'}, { 'key': 'R20-20231222', 'doi-asserted-by': 'crossref', 'first-page': '211', 'DOI': '10.3390/pathogens12020211', 'article-title': 'Supporting the aspecific physiological defenses of upper airways ' 'against emerging SARS-CoV-2 variants.', 'volume': '12', 'author': 'Cegolon', 'year': '2023', 'journal-title': 'Pathogens'}, { 'key': 'R21-20231222', 'doi-asserted-by': 'crossref', 'first-page': '2502', 'DOI': '10.3390/pharmaceutics14112502', 'article-title': 'Early negativization of SARS-CoV-2 infection by nasal spray of seawater ' 'plus additives: the RENAISSANCE open-label controlled clinical trial.', 'volume': '14', 'author': 'Cegolon', 'year': '2022', 'journal-title': 'Pharmaceutics'}, { 'key': 'R22-20231222', 'doi-asserted-by': 'crossref', 'first-page': '863', 'DOI': '10.1016/S2213-2600(22)00126-6', 'article-title': 'Health outcomes in people 2 years after surviving hospitalisation with ' 'COVID-19: a longitudinal cohort study.', 'volume': '10', 'author': 'Huang', 'year': '2022', 'journal-title': 'Lancet Respir Med'}, { 'key': 'R23-20231222', 'doi-asserted-by': 'crossref', 'first-page': '1191', 'DOI': '10.1093/cid/ciab611', 'article-title': 'Persistent symptoms in adult patients 1 year after coronavirus disease ' '2019 (COVID-19): a prospective cohort Study.', 'volume': '74', 'author': 'Seeßle', 'year': '2022', 'journal-title': 'Clin Infect Dis'}, { 'key': 'R24-20231222', 'doi-asserted-by': 'crossref', 'first-page': 'e069761', 'DOI': '10.1136/bmj-2021-069761', 'article-title': 'Clinical severity of, and effectiveness of mRNA vaccines against, ' 'covid-19 from omicron, delta, and alpha SARS-CoV-2 variants in the ' 'United States: prospective observational study.', 'volume': '376', 'author': 'Lauring', 'year': '2022', 'journal-title': 'BMJ'}, { 'key': 'R25-20231222', 'doi-asserted-by': 'crossref', 'first-page': '1943', 'DOI': '10.1007/s11606-021-07242-1', 'article-title': 'Post-COVID-19 syndrome in outpatients: a cohort study.', 'volume': '37', 'author': 'Desgranges', 'year': '2022', 'journal-title': 'J Gen Intern Med'}, { 'key': 'R26-20231222', 'doi-asserted-by': 'crossref', 'first-page': '66', 'DOI': '10.1007/s12016-021-08848-3', 'article-title': 'A review of persistent post-COVID syndrome (PPCS).', 'volume': '64', 'author': 'Oronsky', 'year': '2023', 'journal-title': 'Clin Rev Allergy Immunol'}, { 'key': 'R27-20231222', 'doi-asserted-by': 'crossref', 'first-page': '1', 'DOI': '10.1016/j.jmii.2022.10.003', 'article-title': 'Long COVID: an inevitable sequela of SARS-CoV-2 infection.', 'volume': '56', 'author': 'Lai', 'year': '2023', 'journal-title': 'J Microbiol Immunol Infect'}, { 'key': 'R28-20231222', 'doi-asserted-by': 'crossref', 'first-page': '497', 'DOI': '10.1016/S0140-6736(20)30183-5', 'article-title': 'Clinical features of patients infected with 2019 novel coronavirus in ' 'Wuhan, China.', 'volume': '395', 'author': 'Huang', 'year': '2020', 'journal-title': 'Lancet'}, { 'key': 'R29-20231222', 'doi-asserted-by': 'crossref', 'first-page': '277', 'DOI': '10.1080/22221751.2021.2023329', 'article-title': 'SARS-CoV-2 Omicron variant shows less efficient replication and fusion ' 'activity when compared with Delta variant in TMPRSS2-expressed cells.', 'volume': '11', 'author': 'Zhao', 'year': '2022', 'journal-title': 'Emerg Microbes Infect'}, { 'key': 'R30-20231222', 'doi-asserted-by': 'crossref', 'first-page': '3', 'DOI': '10.1038/s41580-021-00418-x', 'article-title': 'Mechanisms of SARS-CoV-2 entry into cells.', 'volume': '23', 'author': 'Jackson', 'year': '2022', 'journal-title': 'Nat Rev Mol Cell Biol'}, { 'key': 'R31-20231222', 'doi-asserted-by': 'crossref', 'first-page': '1016', 'DOI': '10.1016/j.cell.2020.04.035', 'article-title': 'SARS-CoV-2 receptor ACE2 is an interferon-stimulated gene in human ' 'airway epithelial cells and is detected in specific cell subsets across ' 'tissues.', 'volume': '181', 'author': 'Ziegler', 'year': '2020', 'journal-title': 'Cell'}, { 'key': 'R32-20231222', 'doi-asserted-by': 'crossref', 'first-page': '830', 'DOI': '10.15585/mmwr.mm7125e2', 'article-title': 'Hospitalization and emergency department encounters for COVID-19 after ' 'Paxlovid treatment – California, December 2021-May 2022.', 'volume': '71', 'author': 'Malden', 'year': '2022', 'journal-title': 'MMWR Morb Mortal Wkly Rep'}], 'container-title': 'Medicine', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://journals.lww.com/10.1097/MD.0000000000036714', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2023, 12, 22]], 'date-time': '2023-12-22T19:01:37Z', 'timestamp': 1703271697000}, 'score': 1, 'resource': {'primary': {'URL': 'https://journals.lww.com/10.1097/MD.0000000000036714'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2023, 12, 22]]}, 'references-count': 31, 'journal-issue': {'issue': '51', 'published-print': {'date-parts': [[2023]]}}, 'URL': 'http://dx.doi.org/10.1097/MD.0000000000036714', 'relation': {}, 'ISSN': ['0025-7974', '1536-5964'], 'subject': ['General Medicine'], 'published': {'date-parts': [[2023, 12, 22]]}}