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Research Evaluation of Safety and Impact in Long COVID Intervention with Ensitrelvir for National Cohort Efficacy (RESILIENCE study)

Ensitrelvir for Long COVID (RESILIENCE study)

Kutsuna Satoshi

The University of Osaka Hospital

2-15, Yamadaoka, Suita-shi, Osaka

kutsuna@hp-infect.med.osaka-u.ac.jp

Kutsuna Satoshi

Osaka University Hospital

2-15, Yamadaoka, Suita-shi, Osaka

+81-6-6879-5111

kutsuna@hp-infect.med.osaka-u.ac.jp

Not Recruiting

Feb. 16, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1) Patients with SARS-CoV-2 infection diagnosed at a partner site based on result of nucleic acid (e.g., reverse-transcriptase PCR, Loop-mediated Isothermal Amplification) or antigen test
2) Patients with mild COVID-19 infection based on severity classification definition by New Coronavirus Infectious Disease (COVID-19) Medical Treatment Guide Version 10.0
3) Patients who are expected to start the study drug within 72 hours from onset of COVID-19
4) Patients with pyrexia of >= 37.0 degree Celsius at diagnosis of COVID-19 at a partner site
5) Patients who can be pregnant must agree to use effective contraception in sexual activity from study entry through 14 days after the last dose of study drug
6) Patients with age >=18 years at informed consent
7) Patients who can provide a written informed consent

1) Patients at high risk of developing severe COVID-19
2) Patients who have taken any of the following drugs for COVID-19 from onset of COVID-19 or within 15 days prior to informed consent
-Antiviral drug: e.g., remdesivir, molnupiravir, nirmatrelvir/ritonavir, ensitrelvir fumaric acid
-Anti-SARS-CoV-2 monoclonal antibody: e.g., casirivimab and imdevimab, sotrovimab, tixagevimab and cilgavimab
3) Patients who have taken any of the humanized anti-interleukin-6 receptor (IL-6R) monoclonal antibody (e.g., tocilizumab) or inhibitor of janus kinase (e.g., baricitinib. (excluding topical application)) or corticosteroids [oral, Suppository, or injection] within 2 weeks prior to Informed consent
4) Patients who have participated in a clinical trial for a COVID-19 treatment drugs after onset of current COVID-19 episode
5) Patients who are unable to have an online interview with the investigator/subinvestigator using a cell phone
6) Patients who are unable to enter the electronic patient reported outcome system via a cell phone
7) Patients with allergy/sensitivity or any hypersensitivity to components of ensitrelvir
8) Patients who are currently taking contraindicated drugs with ensiterelvir fumaric acid, or patients who are scheduled to take contraindicated drugs during the treatment period of or within 2 weeks after the last dose of study drug
9) Patients with renal or hepatic dysfunction who are receiving colchicine
10) Patients who are pregnant.
11) Patients who are breastfeeding
12) Patients with sever hepatic dysfunction
13) Patients with immunocompromised condition or undergoing hemodialysis
14) Patients with other infectious diseases
15) Patients who are participating in other intervention studies or have history of participating this study
16) Patients who have participated in clinical trial for drugs within the past 1 year
17) Patients who are considered ineligible for the study by the investigator/subinvestigator for any other reasons

Both

COVID-19

Ensitrelvir
375 mg (3 tablets) for Day 1 and 125 mg (1 tablet) for Day 2 to 5 once daily

Placebo
3 tablets on Day 1 and 1 tablet on Day 2 to 5

Proportion of patients with either "any of symptoms of fatigue, shortness of breath or difficulty breathing, smell disturbance, taste disturbance at consecutive 1 and 3 months after the start of treatment" or "any of symptoms of difficulty with concentration and thinking, difficulty reasoning and solving problems, memory loss (short or long term) at 3 months after the start of treatment".

1) Proportion of patients with either "any of symptoms of fatigue, shortness of breath or difficulty breathing, smell disturbance, taste disturbance at consecutive 1 and 3 months after the start of treatment" or "any of symptoms of difficulty with concentration and thinking, difficulty reasoning and solving problems, memory loss (short or long term) at 3 months after the start of treatment" (regarded as COVID-19-related).
2) Proportion of patients with either "any of symptoms of fatigue, shortness of breath or difficulty breathing, smell disturbance, and taste disturbance at consecutive 1, 3 and 6 months after the start of treatment" or "any of symptoms of difficulty with concentration and thinking, difficulty reasoning and solving problems, and memory loss (short or long term) at 6 months after the start of treatment".
3) Proportion of patients with either "any of symptoms of fatigue, shortness of breath or difficulty breathing, smell disturbance, and taste disturbance at consecutive 1, 3 and 6 months after the start of treatment" or "any of symptoms of difficulty with concentration and thinking, difficulty reasoning and solving problems, and memory loss (short or long term) at 6 months after the start of treatment" (regarded as COVID-19-related).
4) Proportion of patients with any of symptoms of fatigue, shortness of breath or difficulty breathing, smell disturbance, and taste disturbance at consecutive 1 and 3 months after the start of treatment.
5) Proportion of patients with any of symptoms of fatigue, shortness of breath or difficulty breathing, smell disturbance, and taste disturbance at consecutive 1 and 3 months after the start of treatment (regarded as COVID-19-related).
6) Proportion of patients with each symptom of fatigue, shortness of breath or difficulty breathing, smell disturbance, and taste disturbance at consecutive 1 and 3 months after the start of treatment.
7) Proportion of patients with each symptom of fatigue, shortness of breath or difficulty breathing, smell disturbance, and taste disturbance at consecutive 1 and 3 months after the start of treatment (regarded as COVID-19-related).
8) Proportion of patients with any of symptoms of difficulty with concentration and thinking, difficulty reasoning and solving problems, and memory loss (short or long term) at 3 months after the start of treatment.
9) Proportion of patients with any of symptoms of difficulty with concentration and thinking, difficulty reasoning and solving problems, and memory loss (short or long term) at 3 months after the start of treatment (regarded as COVID-19-related).
10) Proportion of patients with each symptom of difficulty with concentration and thinking, difficulty reasoning and solving problems, and memory loss (short or long term) at 3 months after the start of treatment.
11) Proportion of patients with each symptom of difficulty with concentration and thinking, difficulty reasoning and solving problems, and memory loss (short or long term) at 3 months after the start of treatment (regarded as COVID-19-related).
12) Proportion of patients who do not returned to their usual (pre-COVID-19) health and have any of 14 COVID-19 symptoms (fatigue, body pain or muscle pain or aches, headache, chills, feeling feverish, stuffy nose or runny nose, sore throat, cough, shortness of breath or difficulty breathing, nausea, vomiting, diarrhea, smell disturbance, taste disturbance) at 3 months after starting treatment.
13) Proportion of patients who do not return to their usual (pre-COVID-19) health and have any of 4 neurological symptoms (difficulty with concentration and thinking, difficulty reasoning and solving problems, memory loss (short or long term), insomnia) at 3 months after starting treatment.
14) Proportion of patients who do not return to their usual (pre-COVID-19) health and have any of symptoms of fatigue, body pain or muscle pain or aches, headache, chills, feeling feverish, stuffy nose or runny nose, sore throat, cough, shortness of breath or difficulty breathing, nausea, vomiting, diarrhea, smell disturbance, taste disturbance, difficulty with concentration and thinking, difficulty reasoning and solving problems, memory loss (short or long term), insomnia, hair loss, palpitations or fast heartbeat, joint pain, decreased appetite, dizziness/balance issues, chest pain, skin rash at 3 months after starting treatment.

+81-6-6210-8296

Feb. 08, 2024

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