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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Vydáno v:PloS one Ročník 20; číslo 11; s. e0335609
Hlavní autoři: Konishi, Keiji, Yamamoto, Shungo, Sada, Ryuichi Minoda, Asano, Kento, Onozuka, Daisuke, Tanaka, Shintaro, Miyazawa, Shogo, Kinoshita, Masahiro, Kutsuna, Satoshi
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States Public Library of Science 03.11.2025
Public Library of Science (PLoS)
Témata:
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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Popis
Shrnutí: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.
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SourceType-Scholarly Journals-1
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ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0335609