Research to evaluate safety and impact of long COVID intervention with Ensitrelvir for National Cohort (RESILIENCE Study): A protocol for a randomized, double-blind, placebo-controlled trial

Long COVID, characterized by persistent symptoms following acute coronavirus disease (COVID-19), presents a substantial challenge to global health. Ensitrelvir fumarate, a novel oral antiviral agent, has demonstrated efficacy in treating of mild-to-moderate COVID-19. This study aims to evaluate the...

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Published in:	PloS one Vol. 20; no. 11; p. e0335609
Main Authors:	Konishi, Keiji, Yamamoto, Shungo, Sada, Ryuichi Minoda, Asano, Kento, Onozuka, Daisuke, Tanaka, Shintaro, Miyazawa, Shogo, Kinoshita, Masahiro, Kutsuna, Satoshi
Format:	Journal Article
Language:	English
Published:	United States Public Library of Science 03.11.2025 Public Library of Science (PLoS)
Subjects:	Antiviral agents Antiviral drugs Clinical trials Cohort Studies Consent Contraindications Coronaviruses COVID-19 COVID-19 - virology COVID-19 Drug Treatment Data collection Double-Blind Method Drug dosages Dyspnea Effectiveness Global health Health services Humans Indazoles Infections Japan - epidemiology Kinases Long COVID Medical treatment Memory Monoclonal antibodies Olfaction Patient outcomes Patients Placebos Public health Quality of life Questionnaires Randomized Controlled Trials as Topic Registries Regulatory approval Risk factors Safety Safety and security measures SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 Signs and symptoms Testing Triazines Triazoles Japan
ISSN:	1932-6203, 1932-6203
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Abstract	Long COVID, characterized by persistent symptoms following acute coronavirus disease (COVID-19), presents a substantial challenge to global health. Ensitrelvir fumarate, a novel oral antiviral agent, has demonstrated efficacy in treating of mild-to-moderate COVID-19. This study aims to evaluate the efficacy and safety of ensitrelvir in the prevention of Long COVID in patients without risk factors for severe COVID-19. This multi-center, randomized, double-blind, placebo-controlled trial adopts a decentralized clinical trial design, with participants recruited through partner healthcare institutions. Adults with mild COVID-19 will be randomized within 72 hours of symptom onset in a ratio of 1:1 to receive ensitrelvir (375 mg on day 1, followed by 125 mg once daily on days 2–5) or placebo. The primary efficacy endpoint is the proportion of patients with either “symptoms of fatigue, shortness of breath, difficulty breathing, or disturbances in smell or taste at 1 and 3 months post-treatment initiation” or “symptoms of difficulty with concentration and thinking, difficulty of reasoning and solving problems, or memory loss at 3 months post-treatment initiation”. Secondary endpoints include combinations of various symptoms, quality of life, and work productivity. The target sample size is 2,000 participants. This trial will generate data on the potential of ensitrelvir to prevent Long COVID, with important implications for patient care and public health. The decentralized design enables efficient data collection and minimizes participant burden.
AbstractList	Long COVID, characterized by persistent symptoms following acute coronavirus disease (COVID-19), presents a substantial challenge to global health. Ensitrelvir fumarate, a novel oral antiviral agent, has demonstrated efficacy in treating of mild-to-moderate COVID-19. This study aims to evaluate the efficacy and safety of ensitrelvir in the prevention of Long COVID in patients without risk factors for severe COVID-19. This multi-center, randomized, double-blind, placebo-controlled trial adopts a decentralized clinical trial design, with participants recruited through partner healthcare institutions. Adults with mild COVID-19 will be randomized within 72 hours of symptom onset in a ratio of 1:1 to receive ensitrelvir (375 mg on day 1, followed by 125 mg once daily on days 2-5) or placebo. The primary efficacy endpoint is the proportion of patients with either "symptoms of fatigue, shortness of breath, difficulty breathing, or disturbances in smell or taste at 1 and 3 months post-treatment initiation" or "symptoms of difficulty with concentration and thinking, difficulty of reasoning and solving problems, or memory loss at 3 months post-treatment initiation". Secondary endpoints include combinations of various symptoms, quality of life, and work productivity. The target sample size is 2,000 participants. This trial will generate data on the potential of ensitrelvir to prevent Long COVID, with important implications for patient care and public health. The decentralized design enables efficient data collection and minimizes participant burden. Trial registration This study was registered with the Japan Registry of Clinical Trials on February 16, 2024 (jRCTs051230184, Long COVID, characterized by persistent symptoms following acute coronavirus disease (COVID-19), presents a substantial challenge to global health. Ensitrelvir fumarate, a novel oral antiviral agent, has demonstrated efficacy in treating of mild-to-moderate COVID-19. This study aims to evaluate the efficacy and safety of ensitrelvir in the prevention of Long COVID in patients without risk factors for severe COVID-19. This multi-center, randomized, double-blind, placebo-controlled trial adopts a decentralized clinical trial design, with participants recruited through partner healthcare institutions. Adults with mild COVID-19 will be randomized within 72 hours of symptom onset in a ratio of 1:1 to receive ensitrelvir (375 mg on day 1, followed by 125 mg once daily on days 2–5) or placebo. The primary efficacy endpoint is the proportion of patients with either “symptoms of fatigue, shortness of breath, difficulty breathing, or disturbances in smell or taste at 1 and 3 months post-treatment initiation” or “symptoms of difficulty with concentration and thinking, difficulty of reasoning and solving problems, or memory loss at 3 months post-treatment initiation”. Secondary endpoints include combinations of various symptoms, quality of life, and work productivity. The target sample size is 2,000 participants. This trial will generate data on the potential of ensitrelvir to prevent Long COVID, with important implications for patient care and public health. The decentralized design enables efficient data collection and minimizes participant burden. This study was registered with the Japan Registry of Clinical Trials on February 16, 2024 (jRCTs051230184, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs051230184). Long COVID, characterized by persistent symptoms following acute coronavirus disease (COVID-19), presents a substantial challenge to global health. Ensitrelvir fumarate, a novel oral antiviral agent, has demonstrated efficacy in treating of mild-to-moderate COVID-19. This study aims to evaluate the efficacy and safety of ensitrelvir in the prevention of Long COVID in patients without risk factors for severe COVID-19. This multi-center, randomized, double-blind, placebo-controlled trial adopts a decentralized clinical trial design, with participants recruited through partner healthcare institutions. Adults with mild COVID-19 will be randomized within 72 hours of symptom onset in a ratio of 1:1 to receive ensitrelvir (375 mg on day 1, followed by 125 mg once daily on days 2–5) or placebo. The primary efficacy endpoint is the proportion of patients with either “symptoms of fatigue, shortness of breath, difficulty breathing, or disturbances in smell or taste at 1 and 3 months post-treatment initiation” or “symptoms of difficulty with concentration and thinking, difficulty of reasoning and solving problems, or memory loss at 3 months post-treatment initiation”. Secondary endpoints include combinations of various symptoms, quality of life, and work productivity. The target sample size is 2,000 participants. This trial will generate data on the potential of ensitrelvir to prevent Long COVID, with important implications for patient care and public health. The decentralized design enables efficient data collection and minimizes participant burden.Trial registrationThis study was registered with the Japan Registry of Clinical Trials on February 16, 2024 (jRCTs051230184, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs051230184). This study was registered with the Japan Registry of Clinical Trials on February 16, 2024 (jRCTs051230184, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs051230184).TRIAL REGISTRATIONThis study was registered with the Japan Registry of Clinical Trials on February 16, 2024 (jRCTs051230184, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs051230184). Long COVID, characterized by persistent symptoms following acute coronavirus disease (COVID-19), presents a substantial challenge to global health. Ensitrelvir fumarate, a novel oral antiviral agent, has demonstrated efficacy in treating of mild-to-moderate COVID-19. This study aims to evaluate the efficacy and safety of ensitrelvir in the prevention of Long COVID in patients without risk factors for severe COVID-19. This multi-center, randomized, double-blind, placebo-controlled trial adopts a decentralized clinical trial design, with participants recruited through partner healthcare institutions. Adults with mild COVID-19 will be randomized within 72 hours of symptom onset in a ratio of 1:1 to receive ensitrelvir (375 mg on day 1, followed by 125 mg once daily on days 2–5) or placebo. The primary efficacy endpoint is the proportion of patients with either “symptoms of fatigue, shortness of breath, difficulty breathing, or disturbances in smell or taste at 1 and 3 months post-treatment initiation” or “symptoms of difficulty with concentration and thinking, difficulty of reasoning and solving problems, or memory loss at 3 months post-treatment initiation”. Secondary endpoints include combinations of various symptoms, quality of life, and work productivity. The target sample size is 2,000 participants. This trial will generate data on the potential of ensitrelvir to prevent Long COVID, with important implications for patient care and public health. The decentralized design enables efficient data collection and minimizes participant burden. Trial registration This study was registered with the Japan Registry of Clinical Trials on February 16, 2024 (jRCTs051230184, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs051230184).
Audience	Academic
Author	Kinoshita, Masahiro Konishi, Keiji Onozuka, Daisuke Yamamoto, Shungo Asano, Kento Kutsuna, Satoshi Tanaka, Shintaro Sada, Ryuichi Minoda Miyazawa, Shogo
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Cites_doi	10.1016/S0140-6736(23)00810-3 10.1007/s40261-023-01309-z 10.1016/j.eclinm.2021.101019 10.1038/s41598-023-36995-4 10.1016/j.antiviral.2024.105958 10.1021/acs.jmedchem.2c00117 10.1001/jamanetworkopen.2021.28568 10.1128/aac.00697-22 10.1001/jamainternmed.2023.0743 10.1001/jamanetworkopen.2023.54991 10.1080/23744235.2021.1924397 10.1038/s41598-021-95565-8 10.1001/jama.2023.8823
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Snippet	Long COVID, characterized by persistent symptoms following acute coronavirus disease (COVID-19), presents a substantial challenge to global health. Ensitrelvir... This study was registered with the Japan Registry of Clinical Trials on February 16, 2024 (jRCTs051230184,...
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SubjectTerms	Antiviral agents Antiviral drugs Clinical trials Cohort Studies Consent Contraindications Coronaviruses COVID-19 COVID-19 - virology COVID-19 Drug Treatment Data collection Double-Blind Method Drug dosages Dyspnea Effectiveness Global health Health services Humans Indazoles Infections Japan - epidemiology Kinases Long COVID Medical treatment Memory Monoclonal antibodies Olfaction Patient outcomes Patients Placebos Public health Quality of life Questionnaires Randomized Controlled Trials as Topic Registries Regulatory approval Risk factors Safety Safety and security measures SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 Signs and symptoms Testing Triazines Triazoles
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Title	Research to evaluate safety and impact of long COVID intervention with Ensitrelvir for National Cohort (RESILIENCE Study): A protocol for a randomized, double-blind, placebo-controlled trial
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