Merck & Co., Inc., Rahway, New Jersey, USA.
Jadestone Clinical Research, LLC, Rockville, Maryland, USA.
Microbiol Spectr. 2024 Mar 5;12(3):e0356323. doi: 10.1128/spectrum.03563-23. Epub 2024 Feb 1.
This exploratory 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, = 302) and May 2021 to October 2021 (Phase 3, = 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.
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.
已知冠状病毒病 2019（COVID-19）会发生呼吸道病毒合并感染。在 2020 年 10 月至 2021 年 10 月期间进行的 MOVe-OUT 试验中，对接受莫努匹韦与安慰剂治疗的非住院轻中度 COVID-19 成年患者进行了一项探索性分析，评估了呼吸道病毒合并感染的发生率及其对临床结局的影响，试验中患者接受 5 天莫努匹韦或安慰剂治疗（NCT04575597）。该试验分为 2 期（n=302）和 3 期（n=1,433），2 期于 2020 年 10 月至 2021 年 1 月进行，3 期于 2021 年 5 月至 10 月进行。在总计 1735 名随机分组的参与者中，有 1674 名进行了基线呼吸道病原体检测（采用 Luminex MAGPIX 仪器的 NxTAG 呼吸道病原体检测试剂盒），69 名（4.1%）存在至少一种其他呼吸道病毒合并感染。在基线时最常检测到的合并感染病原体是人鼻病毒/肠道病毒（39/69，56.5%）。在改良意向治疗人群中，有 2 名合并感染呼吸道 RNA 病毒的患者在第 29 天前住院并接受了呼吸道干预，无患者死亡；莫努匹韦组的 1 名患者合并感染人鼻病毒/肠道病毒，安慰剂组的 1 名患者合并感染人偏肺病毒。莫努匹韦组与安慰剂组中无合并感染的参与者分别有 6.2%和 9.0%住院或死亡，超过 90%的参与者无需进行呼吸道干预。在莫努匹韦组和安慰剂组中，基线时检测到的大多数合并感染呼吸道 RNA 病毒在治疗结束时均未被检测到。总之，与基线时未合并感染另一种呼吸道 RNA 病毒的参与者相比，合并感染 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、需要呼吸道干预的可能性均无差异。
已知冠状病毒病 2019（COVID-19）会发生呼吸道病毒合并感染。在 2020 年 10 月至 2021 年 10 月期间进行的 MOVe-OUT 试验中，对接受莫努匹韦与安慰剂治疗的非住院轻中度 COVID-19 成年患者进行了一项队列研究，在接受治疗的患者中，4.1%的患者存在经确认的病毒合并感染；采用 NxTAG 呼吸道病原体检测试剂盒检测到最常见的病原体为人鼻病毒/肠道病毒。与未合并感染病毒的参与者相比，合并感染 SARS-CoV-2 和另一种呼吸道 RNA 病毒的参与者临床结局更差的可能性并无差异，且在两组中，许多合并感染的呼吸道 RNA 病毒在 5 天治疗期结束时已不再被检测到。
