JPRN-jRCT2031220558招募中2 期
A placebo-controlled, double-blind, randomized controlled trial on the effect of fluvoxamine to prevent exacerbation of novel coronavirus infection (COVID-19) (Investigator-initiated clinical trial: FLVOCCO study) Phase II study - FLVOCCO study
iitsu Tomihisa0 个研究点目标入组 80 人开始时间: 2023年1月6日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 25age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients who meet all of the following conditions are eligible.
- •1) Patients with symptoms of mild to moderate I (no respiratory failure) (corresponding to scores 1 and 2 of the primary endpoint) in the Guidelines for medical care for new coronavirus infection (COVID-19) (version 8.1).
- •2) Patients with confirmed fever (37.5 degree or higher) within 72 hours prior to obtaining consent.
- •3) Patients with one or more of the following symptoms at the time of screening
- •Cough, shortness of breath, myalgia, nasal discharge, sore throat, headache, nausea/vomiting, abdominal pain, diarrhea, anosmia (loss of sense of smell), loss of taste (loss of taste)
- •4) Patients whose SARS-CoV-2 was detected by PCR test (nucleic acid amplification method) or antigen test from samples derived from the upper and lower respiratory tract within 3 days before obtaining informed consent.
- •5) Patients of Japanese nationality who are at least 25 years of age at the time of consent.
- •6) Patients who have given their voluntary written informed consent after receiving a sufficient explanation regarding their participation in this clinical trial.
排除标准
- •Those who meet any of the following conditions are not eligible.
- •1) Patients who have passed more than 8 days from symptom onset to registration.
- •2) Patients with a percutaneous arterial oxygen saturation (SpO2) of 93% or less.
- •3) Suicidal patients who meet any of the following criteria:
- •- Subjects who currently or within the past 6 months had suicidal ideation with any form of suicidal intention according to the Columbia Suicide Rating Scale (C-SSRS). (Item 4 [Some intention to commit suicide but no specific plan] or Item 5 [Active suicidal ideation - with specific plan and intention] equals YES. Only subjects who meet only Item 1 to Item 3 in the suicidal ideation section can be enrolled at the discretion of the investigator or subinvestigator.)
- •- Subjects who have experienced any suicidal behavior according to C-SSRS within the past year.
- •4) Patients with psychiatric disorders such as schizophrenia, mood disorders (bipolar disorder and depression), and personality disorders, and patients with a history of them.
- •5) Patients with convulsive diseases such as epilepsy or a history of these diseases.
- •6) Patients with cerebral organic disorders or comorbid disorders with high impulsivity.
- •7) Patients with severe heart disease (fatal arrhythmia, pacemaker-introduced patients).
- •8) Patients with a history or complication of malignant tumor. However, patients who have a history but have not recurred for 5 years or more can be registered.
- •9) Patients with a history of bleeding disorders or a bleeding diathesis.
- •10) Patients with glaucoma or intraocular hypertension.
- •11) Dialysis patients with severe renal dysfunction.
- •12) Patients with severe hepatic dysfunction (AST or ALT exceeding 5 times the institution standard).
- •13) Patients with uncontrolled diabetes mellitus (diabetic patients with HbA1c 9.0% or more despite being treated for diabetes).
- •14) Women who are breastfeeding, pregnant, or may become pregnant.
- •15) Immunocompromised (organ transplantation, bone marrow transplantation, AIDS, biologics and/or high-dose steroids (>20 mg prednisolone per day)).
- •16)Patients who are receiving drugs that are contraindicated for fluvoxamine (pimozide, tizanidine hydrochloride, ramelteon, melatonin).
- •17) Patients within 4 weeks after discontinuation of fluvoxamine.
- •18) Patients with a history of serotonin syndrome.
- •19) Patients who are receiving monoamine oxidase (MAO) inhibitors (selegiline hydrochloride, rasagiline mesylate, safinamide mesylate), drugs with serotonergic effects that may cause serotonin syndrome, or within 2 weeks after discontinuation .
- •20)Patients who are on or within 2 weeks after discontinuation of psychotropic drugs that have or may have agonist/antagonist effects on sigma-1 receptors.
- •21)Patients who are receiving approved drugs for the treatment of COVID-19 mild to moderate I, or within 2 weeks after discontinuing the drug.
- •22) Patients who are otherwise judged by the investigator or subinvestigator to be unsuitable for the safe conduct of this study.
研究者
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