JPRN-jRCTs031230490招募中Unknown
A randomized controlled trial of anti-inflammatory analgesics after COVID-19 vaccination in Japan
Kobashi Hiroe0 个研究点目标入组 104 人开始时间: 2023年12月4日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 104
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Those who meet all of the following selection criteria and who have obtained consent from the person himself/herself.
- •1) Over 18 years old
- •2) Gender: Any
- •3) Eligible for COVID-19 vaccine booster in accordance with the instructions of the Ministry of Health, Labor and Welfare
- •4) Healthy or stable chronic condition without major changes in treatment or hospitalization over the past 6 weeks
- •5) Those who can agree to contraception in order to take drugs on the day of COVID-19 vaccination and the day after that
排除标准
- •Those who meet even one of the following exclusion criteria will be excluded from the target.
- •(1) Persons who have not received mRNA or COVID-19 vaccine
- •(2) Persons who have taken antipyretic analgesics or acetaminophen within 24 hours prior to booster vaccination
- •(3) Patients with a contraindication or history of severe adverse reaction to mRNA or COVID-19 vaccine
- •(4) Allergy or intolerance to acetaminophen
- •5) Patients on chronic treatment with NSAIDs
- •6) Patients with peptic ulcer
- •(7) Patients with aspirin asthma or with a history of aspirin asthma
- •(8) Patients with severe cardiac dysfunction
- •(9) Patients with a history of immunodeficiency (including but not limited to CD4 count below 200, progressive hypogammaglobulinemia, CVID)
- •(10) Patients with a history of systemic steroid therapy, active treatment with immunosuppressive agents including DMAR, small molecule drugs used to suppress immune response, biologics, or human blood products in the past 12 months
- •(11) Persons with serious renal disease
- •(12) Persons with serious liver disease
- •(13) Pregnant or lactating mothers
- •(14) Persons deemed unsuitable as subjects by the doctor in charge of conducting the research
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