Abstract:
This exploratory post hoc analysis assessed the incidence of respiratory viral coinfections and their impact on clinical outcomes in non-hospitalized adults with mild-to-moderate coronavirus disease-2019 (COVID-19) treated with molnupiravir versus placebo for 5 days in the Phase 2/3 MOVe-OUT trial (NCT04575597), which took place in October 2020 to January 2021 (Phase 2, n = 302) and May 2021 to October 2021 (Phase 3, n = 1,433). Among 1,735 total randomized participants, 1,674 had a baseline respiratory pathogen panel (NxTAG Respiratory Pathogen Panel for the Luminex MAGPIX instrument) performed and 69 (4.1%) were coinfected with at least one additional respiratory viral pathogen. Human rhinovirus/enterovirus (39/69, 56.5%) was the most common coinfection detected at baseline. In the modified intention-to-treat population, two participants with coinfecting respiratory RNA viruses were hospitalized and received respiratory interventions through Day 29, and none died; one participant in the molnupiravir group was coinfected with human rhinovirus/enterovirus, and one participant in the placebo group was coinfected with human metapneumovirus. Hospitalization or death occurred in 6.2% and 9.0% of non-coinfected participants in the molnupiravir versus placebo group, respectively, and over 90% did not require respiratory interventions. Most coinfecting respiratory RNA viruses detected at baseline were not detected at the end of therapy in both the molnupiravir and placebo groups. In summary, participants coinfected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and another respiratory RNA virus were not more likely to be hospitalized or die, or require respiratory interventions, compared to participants who were not coinfected with another respiratory RNA virus at baseline in both groups.
OBJECTIVE: Respiratory viral coinfections are known to occur with coronavirus disease-2019 (COVID-19). In a cohort of non-hospitalized adults with mild-to-moderate COVID-19 treated with molnupiravir versus placebo in the MOVe-OUT trial during October 2020 to October 2021, 4.1% of participants had a documented viral coinfection; human rhinovirus/enterovirus was the most common pathogen detected with the NxTAG Respiratory Pathogen Panel assay. Participants who had a coinfection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and another respiratory RNA virus were not more likely to have worse clinical outcomes compared to those participants without a viral coinfection, and many coinfecting respiratory RNA viruses were no longer detected at the end of the 5-day treatment period in both groups.
摘要:
这项探索性事后分析评估了在第2/3阶段MOVe-OUT试验(NCT04575597)中,2019年轻度至中度冠状病毒病(COVID-19)非住院成年人接受莫尼皮拉韦与安慰剂治疗5天的呼吸道病毒感染的发生率及其对临床结局的影响,它发生在2020年10月至2021年1月(第二阶段,n=302)和2021年5月至2021年10月(第三阶段,n=1,433)。在1735名随机参与者中,1,674进行了基线呼吸道病原体面板(LuminexMAGPIX仪器的NxTAG呼吸道病原体面板),并且69(4.1%)与至少一种其他呼吸道病毒病原体共感染。人鼻病毒/肠道病毒(39/69,56.5%)是基线检测到的最常见的合并感染。在修改后的意向治疗人群中,两名同时感染呼吸道RNA病毒的参与者住院,并在第29天接受呼吸道干预,没有人死亡;莫努比拉韦组的一名参与者同时感染了人鼻病毒/肠道病毒,安慰剂组的一名参与者同时感染了人类偏肺病毒。与安慰剂组相比,莫努比拉韦组中6.2%和9.0%的非共感染参与者住院或死亡,分别,超过90%的患者不需要呼吸干预.在治疗结束时,莫那普拉韦和安慰剂组均未检测到基线时检测到的大多数共感染呼吸道RNA病毒。总之,合并感染严重急性呼吸道综合征冠状病毒2(SARS-CoV-2)和另一种呼吸道RNA病毒的参与者住院或死亡的可能性并不高,或者需要呼吸干预,与基线时未同时感染另一种呼吸道RNA病毒的参与者进行比较.已知重要呼吸道病毒感染与2019年冠状病毒病(COVID-19)一起发生。在2020年10月至2021年10月的MOVe-OUT试验中,接受莫努比拉韦与安慰剂治疗的轻度至中度COVID-19的非住院成年人队列中,有4.1%的参与者有记录的病毒性合并感染;人鼻病毒/肠道病毒是NxTAG呼吸道病原体小组检测中最常见的病原体。与没有病毒感染的参与者相比,合并感染严重急性呼吸道综合症冠状病毒2(SARS-CoV-2)和另一种呼吸道RNA病毒的参与者的临床结果并不会更差。在5天治疗期结束时,两组均未检测到许多合并感染的呼吸道RNA病毒.