EUCTR2017-003252-24-BG进行中（未招募）1 期
A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ- 53718678 at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female.
- •2. =18 years of age.
- •Note: If the legal age of consent in the jurisdiction in which the study is taking place is >18 years, this respective legal age is binding for
- •eligibility.
- •3. Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and is willing to participate in the study.
- •Note: Prior to signing the main consent form for the study, subjects may specifically allow for the collection and testing of nasal mid-turbinate swabs by signing the pre screening (diagnostic) ICF.
- •4. Subjects must have an acute respiratory illness with signs and symptoms consistent with a viral infection (example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset =5 days from the anticipated time of randomization. Onset of symptoms is defined as the time the subject becomes aware of the first sign and/or symptom consistent with a viral infection. Efforts should be made to determine the time of onset of symptoms as accurately as possible (in relation to routine daily activities).
- •Note: The viral infection may present in any way as long as the underlying precipitant of the illness is considered by the investigator to be due to RSV infection. Examples of such an illness include:
- •- An upper or lower viral respiratory tract infection (eg, flu-like illness”);
- •- Pneumonia;
- •- Respiratory distress;
- •- Asthma exacerbation;
- •- COPD exacerbation.
- •5. Subject has been diagnosed with RSV infection using a rapid polymerase chain reaction (PCR) based (preferably locally available) or rapid-antigen-detection test.
- •Note: If a patient has a positive similar diagnostic test from another study and meets all eligibility criteria for inclusion in this study, this diagnostic test result can be used for confirmation of eligibility.
- •Please refer to the protocol for other inclusion criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •Any potential subject who meets any of the following criteria will be excluded from participating in the study:
- •1. Hospitalized subjects or subjects expected to be hospitalized within 24 hours of screening.
- •Note: Any stay in the emergency room or in the observational unit of at least 24 hours will be considered hospitalization for the purposes of the study.
- •2. History of or concurrent illness (beyond a comorbid condition) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol-specified assessments.
- •3. Subjects who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study.
- •4. Subjects who are considered by the investigator to be immunocompromised within the past 12 months, whether due to underlying medical condition (eg, malignancy or genetic disorder other than immunoglobulin A deficiency, or human immunodeficiency virus [HIV] infection) or medical therapy (eg, medications other than corticosteroids for the treatment of chronic obstructive pulmonary disease (COPD) or asthma exacerbations, chemotherapy, radiation, stem cell or solid organ transplant).
- •5. Subject has known or suspected chronic or acute hepatitis B or C infection.
- •Please refer to the protocol for other exclusion criteria
研究者
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