JPRN-jRCT2031210316进行中（未招募）3 期
A Phase III Confirmatory Study of K-237-Multi-regional, Multi-center, Placebo Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients with mild COVID-19
Tanigawa Ryohei0 个研究点目标入组 1,000 人开始时间: 2021年9月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
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
- >= 12age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria will be eligible for this study.
- •(1) Males and females who are 12 years of age or older at the time of obtaining consent
- •(2) Patients who are confirmed positive for SARS-CoV-2 by antigen test or RT-PCR test using specimens (nasopharynx, nasal cavity, oropharynx, or saliva) collected within 120 hours prior to obtaining consent.
- •(3) Patients who have fevers (>= 37.5 degrees Celsius) and/or at least one of the following symptoms of Score 2 or higher at a screening test:Myalgia, sore throat, diarrhea, nausea, vomiting, cough, and shortness of breath.
- •(4) Patients with a room air oxygen saturation (SpO2) of 96% or higher at the time of the screening test.
排除标准
- •Subjects who meet any one of the following criteria will be excluded from this study.
- •(1) Patients who have had symptoms caused by COVID-19 for more than 6 days on the day of initiation of investigational drug administration (Day 1) with the day of onset of symptoms as Day 0.
- •(2) Patients who need to receive concomitant therapy or administration of prohibited drugs during the study period
- •(3) Patients who have taken or received drugs that have or may have antiviral activity against SARS-CoV-2 within 2 weeks prior to the start of study drug administration
- •(4) Patients with suspected complications of infectious diseases other than COVID-19
- •(5) Persons whose weight at the time of the screening test falls into the following categories (The first decimal place of the weight shall be rounded off.)
- •1) Those who are 18 years of age or older at the time of consent and weigh less than 25 kg or more than 127 kg
- •2) Those who are between 12 and 18 years of age and weigh less than 40 kg or 127 kg or more at the time of obtaining consent.
- •(6) Patients undergoing dialysis treatment
- •(7) Patients wno have severe liver dysfunction (hepatic dysfunction, hepatic fibrosis, etc.)
- •(8) Patients wno have complications of poorly controlled hypertension (systolic blood pressure (SBP) of 180 mmHg or more or diastolic blood pressure (DBP) of 110 mmHg or more)
- •(9) Patients requiring oxygen therapy
- •(10) Patients wno have complications of methemoglobinemia or other diseases that may cause measurement errors in the pulse oximeter
研究者
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