Efficacy and safety of molnupiravir in patients with Omicron variant vaccine breakthrough COVID-19 infection: a randomized, controlled trial
Introduction: Randomized, controlled trials of molnupiravir in real-world use during the Omicron wave are scarce. The frequency of hospitalization and death is low, so further research is needed to confirm the virological efficacy of molnupiravir.Methods: A single-center, randomized, controlled clin...
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| Format: | Article |
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Frontiers Media S.A.
2023-11-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1197671/full |
| _version_ | 1797626578790776832 |
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| author | Yayun Liu Shiyong Fan Aijing Xu Lingling Ge Xinyu Wang Xu Dong Mingxiao Xu Wenhan Fan Wu Zhong Xuesong Liang |
| author_facet | Yayun Liu Shiyong Fan Aijing Xu Lingling Ge Xinyu Wang Xu Dong Mingxiao Xu Wenhan Fan Wu Zhong Xuesong Liang |
| author_sort | Yayun Liu |
| collection | DOAJ |
| description | Introduction: Randomized, controlled trials of molnupiravir in real-world use during the Omicron wave are scarce. The frequency of hospitalization and death is low, so further research is needed to confirm the virological efficacy of molnupiravir.Methods: A single-center, randomized, controlled clinical trial was conducted, and 111 hospitalized coronavirus disease 2019 (COVID-19) patients were randomly assigned at a ratio of 1:1. Fifty-three patients in the molnupiravir group were administered 800 mg of molnupiravir twice daily for 5 days in addition to the standard therapy, and 58 patients in the control group only received the standard therapy in accordance with local guidelines. The antiviral effect and adverse events were evaluated during the follow-up.Results: The median viral clearance time in the molnupiravir group was significantly shorter than that in the control group (p = 0.003). Furthermore, patients who started molnupiravir therapy within 3 days had significantly shorter viral clearance time than the controls (p = 0.003). In the vaccinated subgroup, molnupiravir therapy was also associated with a shorter viral clearance time (p = 0.003). A total of three adverse events, which were minor, were reported in the molnupiravir group. One of the patients had mild liver function abnormalities, and all of them were resolved without intervention. However, the remission time was similar between the two tested groups.Conclusion: Molnupiravir exhibited good viral replication inhibitor efficacy in patients with Omicron variant vaccine breakthrough COVID-19 infection.Clinical Trial Registration: [https://www.chictr.org.cn/], identifier [ChiCTR2200059796]. |
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| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-11T10:13:25Z |
| publishDate | 2023-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-0a49eb89eaea42b084c18736f48a5f842023-11-16T12:46:35ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-11-011410.3389/fphar.2023.11976711197671Efficacy and safety of molnupiravir in patients with Omicron variant vaccine breakthrough COVID-19 infection: a randomized, controlled trialYayun Liu0Shiyong Fan1Aijing Xu2Lingling Ge3Xinyu Wang4Xu Dong5Mingxiao Xu6Wenhan Fan7Wu Zhong8Xuesong Liang9Department of Infectious Diseases, First Hospital of Navy Military Medical University, Shanghai, ChinaNational Engineering Research Center for the Emergency Drug, Beijing Institute of Pharmacology and Toxicology, Beijing, ChinaDepartment of Infectious Diseases, First Hospital of Navy Military Medical University, Shanghai, ChinaDepartment of Infectious Diseases, First Hospital of Navy Military Medical University, Shanghai, ChinaDepartment of Infectious Diseases, First Hospital of Navy Military Medical University, Shanghai, ChinaDepartment of Infectious Diseases, First Hospital of Navy Military Medical University, Shanghai, ChinaDepartment of Infectious Diseases, First Hospital of Navy Military Medical University, Shanghai, ChinaDepartment of Infectious Diseases, First Hospital of Navy Military Medical University, Shanghai, ChinaNational Engineering Research Center for the Emergency Drug, Beijing Institute of Pharmacology and Toxicology, Beijing, ChinaDepartment of Infectious Diseases, First Hospital of Navy Military Medical University, Shanghai, ChinaIntroduction: Randomized, controlled trials of molnupiravir in real-world use during the Omicron wave are scarce. The frequency of hospitalization and death is low, so further research is needed to confirm the virological efficacy of molnupiravir.Methods: A single-center, randomized, controlled clinical trial was conducted, and 111 hospitalized coronavirus disease 2019 (COVID-19) patients were randomly assigned at a ratio of 1:1. Fifty-three patients in the molnupiravir group were administered 800 mg of molnupiravir twice daily for 5 days in addition to the standard therapy, and 58 patients in the control group only received the standard therapy in accordance with local guidelines. The antiviral effect and adverse events were evaluated during the follow-up.Results: The median viral clearance time in the molnupiravir group was significantly shorter than that in the control group (p = 0.003). Furthermore, patients who started molnupiravir therapy within 3 days had significantly shorter viral clearance time than the controls (p = 0.003). In the vaccinated subgroup, molnupiravir therapy was also associated with a shorter viral clearance time (p = 0.003). A total of three adverse events, which were minor, were reported in the molnupiravir group. One of the patients had mild liver function abnormalities, and all of them were resolved without intervention. However, the remission time was similar between the two tested groups.Conclusion: Molnupiravir exhibited good viral replication inhibitor efficacy in patients with Omicron variant vaccine breakthrough COVID-19 infection.Clinical Trial Registration: [https://www.chictr.org.cn/], identifier [ChiCTR2200059796].https://www.frontiersin.org/articles/10.3389/fphar.2023.1197671/fullantiviral drugsmolnupiravirsevere acute respiratory syndrome coronavirus 2Omicron variantvaccine breakthrough infection |
| spellingShingle | Yayun Liu Shiyong Fan Aijing Xu Lingling Ge Xinyu Wang Xu Dong Mingxiao Xu Wenhan Fan Wu Zhong Xuesong Liang Efficacy and safety of molnupiravir in patients with Omicron variant vaccine breakthrough COVID-19 infection: a randomized, controlled trial Frontiers in Pharmacology antiviral drugs molnupiravir severe acute respiratory syndrome coronavirus 2 Omicron variant vaccine breakthrough infection |
| title | Efficacy and safety of molnupiravir in patients with Omicron variant vaccine breakthrough COVID-19 infection: a randomized, controlled trial |
| title_full | Efficacy and safety of molnupiravir in patients with Omicron variant vaccine breakthrough COVID-19 infection: a randomized, controlled trial |
| title_fullStr | Efficacy and safety of molnupiravir in patients with Omicron variant vaccine breakthrough COVID-19 infection: a randomized, controlled trial |
| title_full_unstemmed | Efficacy and safety of molnupiravir in patients with Omicron variant vaccine breakthrough COVID-19 infection: a randomized, controlled trial |
| title_short | Efficacy and safety of molnupiravir in patients with Omicron variant vaccine breakthrough COVID-19 infection: a randomized, controlled trial |
| title_sort | efficacy and safety of molnupiravir in patients with omicron variant vaccine breakthrough covid 19 infection a randomized controlled trial |
| topic | antiviral drugs molnupiravir severe acute respiratory syndrome coronavirus 2 Omicron variant vaccine breakthrough infection |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1197671/full |
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