Efficacy and safety of Paxlovid in severe adult patients with SARS-Cov-2 infection: a multicenter randomized controlled study

Liu, Jiao; Pan, Xiaojun; Zhang, Sheng; Li, Ming; Ma, Ke; Fan, Cunyi; Lv, Ying; Guan, Xiangdong; Yang, Yi; Ye, Xiaofei; Deng, Xingqi; Wang, Yunfeng; Qin, Lun–Xiu; Xia, Zhijie; Ge, Zi; Zhou, Quanhong; Zhang, Xian; Ling, Yun; Qi, Tangkai; Wen, Zhenliang; Huang, Sisi; Zhang, Lidi; Wang, Tao; Liu, Yongan; Huang, Yanxia; Li, Wenzhe; Du, Hangxiang; Chen, Yizhu; Xu, Yan; Zhao, Qiang; Zhao, Ren; Annane, Djillali; Qu, Jieming; Chen, Dechang

doi:10.1016/j.lanwpc.2023.100694

Cited by 57 publications

(62 citation statements)

References 18 publications

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“…Hence, we think it would be useful to conduct and improve randomized trials involving vaccinated patients infected by Omicron variant [35]. This is of particular relevance since a newly published multicenter randomized controlled study that aimed at evaluating the efficacy and safety of Paxlovid in hospitalized adult patients with Omicron variant infection showed no significant reduction in the risk of all-cause mortality on day 28 and the duration of SARS-CoV-2 RNA clearance in hospitalized adult COVID-19 patients with severe comorbidities, in discordance with the results obtained previously [36]. Paxlovid consists of two active principles: nirmatrelvir, which is an inhibitor of the SARS-CoV-2 3-chymotrypsin-like cysteine protease enzyme, and ritonavir, a protease inhibitor.…”

Section: Discussionsupporting

confidence: 49%

Use of Remdesivir in Patients with SARS-CoV-2 Pneumonia in a Real-Life Setting during the Second and Third COVID-19 Epidemic Waves

Marocco

Borgo

Tortellini

et al. 2023

Viruses

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In this retrospective comparative study, we evaluated the effectiveness of remdesivir (RDSV) in patients with SARS-CoV-2 pneumonia. Individuals hospitalized between March 2020 and August 2022 at S.M. Goretti Hospital, Latina, with a positive test for SARS-CoV-2 and, concomitantly, pneumonia, were included. The overall survival was the primary endpoint. The composite secondary endpoint included death or progression in severe ARDS at 40 days. The study population was stratified according to treatment into two groups: the RDSV group (patients treated with RDSV-based regimens) and the no-RDSV group (patients treated with any other, not RDSV-based, regimens). Factors associated with death and progression to severe ARDS or death were assessed by multivariable analysis. A total of 1153 patients (632 belonging to the RDSV group and 521 to the no-RDSV group) were studied. The groups were comparable in terms of sex, PaO2/FiO2 at admission, and duration of symptoms before hospitalization. Further, 54 patients (8.5%) in the RDSV group and 113 (21.7%) in the no-RDSV group (p < 0.001) died. RDSV was associated with a significantly reduced hazard ratio (HR) of death (HR, 0.69 [95% CI, 0.49–0.97]; p = 0.03), compared to the no-RDSV group, as well as a significantly reduced OR of progression in severe ARDS or death (OR, 0.70 [95% CI 0.49–0.98]; p = 0.04). An overall significantly higher survival rate was observed in the RDSV group (p < 0.001, by log-rank test). These findings reinforce the survival benefit of RDSV and support its routine clinical use for the treatment of COVID-19 patients.

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Section: Discussionsupporting

confidence: 49%

Use of Remdesivir in Patients with SARS-CoV-2 Pneumonia in a Real-Life Setting during the Second and Third COVID-19 Epidemic Waves

Marocco

Borgo

Tortellini

et al. 2023

Viruses

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“… 15 Interestingly, we found that Azvudine had a stronger protective effect on severe patients with COVID-19 who were not recommended for the use of Paxlovid and molnupiravir. 20 , 21 A previous single arm clinical trial reported that all patients with severe COVID-19 were recovered after oral Azvudine. 13 Azvudine could concentrate in the thymus with its active form after oral administration, effectively inhibit the replication of SARS-CoV-2 in vivo, and protect the immune function of the thymus.…”

Section: Discussionmentioning

confidence: 99%

Oral Azvudine for hospitalised patients with COVID-19 and pre-existing conditions: a retrospective cohort study

et al. 2023

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“…This contrasts with severe cases, where the primary cause of illness is an inflammatory response (41–43). Furthermore, a randomized clinical trial conducted by Liu et al in 2023, which evaluated the efficacy of nirmatrelvir-ritonavir in adult patients hospitalized with SARS-Cov-2 (Omicron BA.2.2 variant) infection and severe comorbidities, did not show any additional benefits in terms of all-cause mortality up to day 28 when compared to standard treatment (39).…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, the Omicron variant of COVID-19 has been demonstrated to have lower rates of hospitalization and mortality compared to previous variants. These factors can affect the effect of treatment with Nirmatrelvir-ritonavir (38,39). Additionally, the efficacy of nirmatrelvir-ritonavir use within the context of the availability of bivalent COVID-19 vaccines requires further consideration and evaluation.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of Nirmatrelvir-Ritonavir for the treatment of patients with mild to moderate COVID-19 and at high risk of hospitalization: Systematic review and meta-analyses of observational studies

Souza

Carrasco²,

Rojas-Cortés

et al. 2023

Preprint

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Objective To assess the effectiveness of nirmatrelvir-ritonavir in the treatment of outpatients with mild to moderate COVID-19 who are at higher risk of developing severe illness, through a systematic review with meta-analyses of observational studies. Methods A systematic search was performed, in accordance with the Cochrane search methods, to identify observational studies that met the inclusion criteria. The outcomes of mortality and hospitalization were analyzed. Search was conducted on PubMed, EMBASE, and The Cochrane Library. Two reviewers independently screened references, selected the studies, extracted the data, assessed the risk of bias using ROBINS-I tool and evaluated the quality of evidence using the GRADE tool. This study followed the PRISMA reporting guideline. Results A total of 16 observational studies and 1,482,923 patients were finally included. The results of the meta-analysis showed that in comparison to standard treatment without antivirals, nirmatrelvir-ritonavir reduced the risk of death by 62% (OR= 0.38; 95% CI: 0.30-0.46; moderate certainty of evidence). In addition, a 53% reduction in the risk of hospital admission was observed (OR = 0.47; 95% CI: 0.36–0.60, with very low certainty of evidence). For the composite outcome of hospitalization and/or mortality, there was a 56% risk reduction (OR=0.44; 95% CI: 0.31-0.64, moderate certainty of evidence). Conclusion The results suggest that nirmatrelvir-ritonavir could be effective in reducing mortality and hospitalization. The results were valid in vaccinated or unvaccinated high-risk individuals with COVID-19. Data from ongoing and future trials may further advance our understanding of the effectiveness and safety of nirmatrelvir-ritonavir and help improve treatment guidelines for COVID-19.

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Efficacy and safety of Paxlovid in severe adult patients with SARS-Cov-2 infection: a multicenter randomized controlled study

Cited by 57 publications

References 18 publications

Use of Remdesivir in Patients with SARS-CoV-2 Pneumonia in a Real-Life Setting during the Second and Third COVID-19 Epidemic Waves

Use of Remdesivir in Patients with SARS-CoV-2 Pneumonia in a Real-Life Setting during the Second and Third COVID-19 Epidemic Waves

Oral Azvudine for hospitalised patients with COVID-19 and pre-existing conditions: a retrospective cohort study

Effectiveness of Nirmatrelvir-Ritonavir for the treatment of patients with mild to moderate COVID-19 and at high risk of hospitalization: Systematic review and meta-analyses of observational studies

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