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

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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.

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Most cited references 31

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Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China

Chaolin Huang, Yeming Wang, Xingwang Li … (2020)

Summary Background A recent cluster of pneumonia cases in Wuhan, China, was caused by a novel betacoronavirus, the 2019 novel coronavirus (2019-nCoV). We report the epidemiological, clinical, laboratory, and radiological characteristics and treatment and clinical outcomes of these patients. Methods All patients with suspected 2019-nCoV were admitted to a designated hospital in Wuhan. We prospectively collected and analysed data on patients with laboratory-confirmed 2019-nCoV infection by real-time RT-PCR and next-generation sequencing. Data were obtained with standardised data collection forms shared by WHO and the International Severe Acute Respiratory and Emerging Infection Consortium from electronic medical records. Researchers also directly communicated with patients or their families to ascertain epidemiological and symptom data. Outcomes were also compared between patients who had been admitted to the intensive care unit (ICU) and those who had not. Findings By Jan 2, 2020, 41 admitted hospital patients had been identified as having laboratory-confirmed 2019-nCoV infection. Most of the infected patients were men (30 [73%] of 41); less than half had underlying diseases (13 [32%]), including diabetes (eight [20%]), hypertension (six [15%]), and cardiovascular disease (six [15%]). Median age was 49·0 years (IQR 41·0–58·0). 27 (66%) of 41 patients had been exposed to Huanan seafood market. One family cluster was found. Common symptoms at onset of illness were fever (40 [98%] of 41 patients), cough (31 [76%]), and myalgia or fatigue (18 [44%]); less common symptoms were sputum production (11 [28%] of 39), headache (three [8%] of 38), haemoptysis (two [5%] of 39), and diarrhoea (one [3%] of 38). Dyspnoea developed in 22 (55%) of 40 patients (median time from illness onset to dyspnoea 8·0 days [IQR 5·0–13·0]). 26 (63%) of 41 patients had lymphopenia. All 41 patients had pneumonia with abnormal findings on chest CT. Complications included acute respiratory distress syndrome (12 [29%]), RNAaemia (six [15%]), acute cardiac injury (five [12%]) and secondary infection (four [10%]). 13 (32%) patients were admitted to an ICU and six (15%) died. Compared with non-ICU patients, ICU patients had higher plasma levels of IL2, IL7, IL10, GSCF, IP10, MCP1, MIP1A, and TNFα. Interpretation The 2019-nCoV infection caused clusters of severe respiratory illness similar to severe acute respiratory syndrome coronavirus and was associated with ICU admission and high mortality. Major gaps in our knowledge of the origin, epidemiology, duration of human transmission, and clinical spectrum of disease need fulfilment by future studies. Funding Ministry of Science and Technology, Chinese Academy of Medical Sciences, National Natural Science Foundation of China, and Beijing Municipal Science and Technology Commission.

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SARS-CoV-2 Receptor ACE2 Is an Interferon-Stimulated Gene in Human Airway Epithelial Cells and Is Detected in Specific Cell Subsets across Tissues

Carly Ziegler, Samuel J Allon, Sarah K Nyquist … (2020)

Summary There is pressing urgency to understand the pathogenesis of the severe acute respiratory syndrome coronavirus clade 2 (SARS-CoV-2), which causes the disease COVID-19. SARS-CoV-2 spike (S) protein binds angiotensin-converting enzyme 2 (ACE2), and in concert with host proteases, principally transmembrane serine protease 2 (TMPRSS2), promotes cellular entry. The cell subsets targeted by SARS-CoV-2 in host tissues and the factors that regulate ACE2 expression remain unknown. Here, we leverage human, non-human primate, and mouse single-cell RNA-sequencing (scRNA-seq) datasets across health and disease to uncover putative targets of SARS-CoV-2 among tissue-resident cell subsets. We identify ACE2 and TMPRSS2 co-expressing cells within lung type II pneumocytes, ileal absorptive enterocytes, and nasal goblet secretory cells. Strikingly, we discovered that ACE2 is a human interferon-stimulated gene (ISG) in vitro using airway epithelial cells and extend our findings to in vivo viral infections. Our data suggest that SARS-CoV-2 could exploit species-specific interferon-driven upregulation of ACE2, a tissue-protective mediator during lung injury, to enhance infection.

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Mechanisms of SARS-CoV-2 entry into cells

Cody B. Jackson, Michael Farzan, Bing Chen … (2021)

The unprecedented public health and economic impact of the COVID-19 pandemic caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been met with an equally unprecedented scientific response. Much of this response has focused, appropriately, on the mechanisms of SARS-CoV-2 entry into host cells, and in particular the binding of the spike (S) protein to its receptor, angiotensin-converting enzyme 2 (ACE2), and subsequent membrane fusion. This Review provides the structural and cellular foundations for understanding the multistep SARS-CoV-2 entry process, including S protein synthesis, S protein structure, conformational transitions necessary for association of the S protein with ACE2, engagement of the receptor-binding domain of the S protein with ACE2, proteolytic activation of the S protein, endocytosis and membrane fusion. We define the roles of furin-like proteases, transmembrane protease, serine 2 (TMPRSS2) and cathepsin L in these processes, and delineate the features of ACE2 orthologues in reservoir animal species and S protein adaptations that facilitate efficient human transmission. We also examine the utility of vaccines, antibodies and other potential therapeutics targeting SARS-CoV-2 entry mechanisms. Finally, we present key outstanding questions associated with this critical process. Entry of SARS-CoV-2 into host cells is mediated by the interaction between the viral spike protein and its receptor angiotensin-converting enzyme 2, followed by virus–cell membrane fusion. Worldwide research efforts have provided a detailed understanding of this process at the structural and cellular levels, enabling successful vaccine development for a rapid response to the COVID-19 pandemic.

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Author and article information

Contributors

Jianchao Xu

Jinzhong Song

Ziyu Xie

Jie Yang

Di Wu

Fengshuang Liu

Yinuo Zhao

Hongmin Zang

Journal

Journal ID (nlm-ta): Medicine (Baltimore)

Journal ID (iso-abbrev): Medicine (Baltimore)

Journal ID (publisher-id): MD

Title: Medicine

Publisher: Lippincott Williams & Wilkins (Hagerstown, MD )

ISSN (Print): 0025-7974

ISSN (Electronic): 1536-5964

Publication date Collection: 22 December 2023

Publication date (Electronic): 22 December 2023

Volume: 102

Issue: 51

Electronic Location Identifier: e36714

Affiliations

[a ] Hebei University of Chinese Medicine, Shijiazhuang, China

[b ] Shijiazhuang People’s Hospital, Shijiazhuang, China

[c ] The Traditional Chinese Medicine Hospital of Shijiazhuang, Shijiazhuang, China

[d ] Hebei Medical University, Shijiazhuang, China

[e ] Hebei General Hospital, Shijiazhuang, China

[f ] Hebei Academy of Chinese Medical Sciences, Shijiazhuang, China

[g ] School of Biological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK

[h ] North China University of Science and Technology, Tangshan, China.

Author notes

[* ]Correspondence: Yubin Zhao, Hebei University of Chinese Medicine, Shijiazhuang 050091, ChinaShijiazhuang People’s Hospital, Shijiazhuang 050000, ChinaNorth China University of Science and Technology, Tangshan 063210, China (e-mail: drzhyubin@ 123456163.com ).

Author information

Yubin Zhao https://orcid.org/0000-0003-1981-9297

Article

Accession ID: 00056

DOI: 10.1097/MD.0000000000036714

PMC ID: 10735069

PubMed ID: 38134107

SO-VID: ded995b9-ac1e-4bc7-bee4-2cbe760a4e35

License:

This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

History

Date received : 21 August 2023

Date received : 23 November 2023

Date accepted : 28 November 2023

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Keywords: adult,clinical trial,covid-19,omicron,paxlovid,sars-cov-2

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Keywords: adult, clinical trial, covid-19, omicron, paxlovid, sars-cov-2

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

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Most cited references 31

Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China

SARS-CoV-2 Receptor ACE2 Is an Interferon-Stimulated Gene in Human Airway Epithelial Cells and Is Detected in Specific Cell Subsets across Tissues

Mechanisms of SARS-CoV-2 entry into cells

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