ISRCTN72088243进行中（未招募）Unknown
A pre- and post-intervention study to assess the efficacy of tocilizumab in reducing mortality in hantavirus pulmonary syndrome
Ministerio de Salud de Rio Negro0 个研究点目标入组 30 人开始时间: 2024年6月26日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- 性别
- All
入选标准
- •1. Diagnosis confirmation: participants must be clinically diagnosed with Hantavirus Pulmonary Syndrome. Diagnosis should be confirmed through one or more of the following:
- •1.1. Detection of hantavirus-specific IgM antibodies in serum.
- •1.2. A four-fold rise in hantavirus-specific IgG antibody titers in paired serum samples.
- •1.3. Positive RT-PCR test for hantavirus RNA in blood or tissue samples.
- •2. Age: participants must be aged 18 years or older. This age criterion ensures that all participants can legally consent to the study and are within the adult age range most commonly affected by HPS.
- •3. Severity of condition: participants must be exhibiting symptoms severe enough to require hospitalization, ensuring the study targets those most likely to benefit from tocilizumab treatment.
- •4. Ability to provide informed consent: participants must be capable of giving informed consent or have a legal guardian who can consent on their behalf if they are incapacitated.
- •5. Treatment window: participants must be eligible to receive the study intervention (tocilizumab) within 24 hours of hospital admission to ensure the treatment is administered in a timely manner, which is critical for its potential efficacy.
- •6. Health status: participants must have no known allergies to tocilizumab or its excipients.
- •7. No severe co-morbid conditions that could interfere with the study outcomes or significantly increase the risk of adverse effects from tocilizumab, such as severe chronic liver disease, known active tuberculosis, or other severe active infections.
- •8. No prior treatment: participants must not have received tocilizumab or other investigational treatments for HPS before enrollment in this study to ensure that any observed effects can be attributed to the study drug.
排除标准
- •1. Previous treatment with tocilizumab or related therapies: participants who have previously received tocilizumab or other monoclonal antibodies targeting IL-6 or IL-6 receptors for any condition.
- •2. Severe allergic reactions: individuals with a history of severe allergic reactions to tocilizumab or any of its excipients.
- •3. Active or latent infections: participants with active, severe infections at the time of screening, such as tuberculosis, HIV, or hepatitis.
- •4. Individuals with a known history of chronic or recurrent infections.
- •5. Pregnancy or lactation: pregnant or breastfeeding women due to the unknown effects of tocilizumab on fetuses or infants.
- •6. Severe comorbid conditions: individuals with uncontrolled cardiovascular, liver, renal, or metabolic diseases that could complicate treatment outcomes.
- •7. Patients with a known history of gastrointestinal perforation within the last 6 months.
- •8. Recent vaccinations: participants who have received live vaccines within 30 days prior to the intended start of treatment.
- •9. Participation in other clinical trials: individuals currently participating in another clinical trial or who have participated in a clinical trial involving an investigational product within the last 30 days.
- •10. Substance abuse: current or recent (within the last year) history of significant alcohol or drug abuse that could interfere with adherence to study protocols.
- •11. Immunosuppression: patients with conditions or on treatments that significantly suppress immune function, such as chemotherapy or high-dose corticosteroids.
- •12. Psychiatric illness: individuals with psychiatric illnesses or conditions that could interfere with their ability to understand or comply with the requirements of the study.
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