EUCTR2021-003237-11-DE进行中（未招募）1 期
Effect of Bronchipret on antiviral immune response in patients with mild COVID-19 (BroVID) - BroVID
Fraunhofer Gesellschaft for its Institute for translationale Medicine and Pharmacology ITMP0 个研究点目标入组 30 人开始时间: 2021年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients = 18 years and = 75 years
- •If > 50 years, complete COVID-19 vaccination mandatory
- •2. SARS-CoV-2 infection confirmed by PCR test = 4 days before screening/baseline visit
- •3. Onset of symptoms < 7 days before screening/baseline visit
- •4. Mild COVID-19 with the following symptoms (outpatient management/non hospitalized patients):
- •? Cough and
- •? At least one other symptom (e.g., sore throat, nasal congestion, headache, nausea, low energy/fatigue, muscle or body ache, shortness of breath, fever, diarrhea, altered sense of smell or taste)
- •5. Written informed consent obtained prior to the initiation of any protocol-required procedures by the patient
- •6. Willingness to comply to study procedures and study protocol
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. WHO score = 3
- •2. Other advanced or chronic lung diseases (COPD, silicosis, bronchial asthma)
- •3. Unable to take oral medication
- •4. BMI > 35 or = 43 kg
- •5. Requirement for oxygen administration
- •6. Current hospitalization
- •7. Known hypersensitivity to the active substances ivy, thyme, plants of the aralia family or other labiates (Lamiaceae), birch, mugwort, celery or to any of the excipients
- •8. Patients with rare hereditary fructose intolerance
- •9. Inability to monitor body temperature
- •10. Patients regularily taking immune suprressive medication, NSARs or steroids (e.g., because of underlying disease)
- •11. Known significant concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient’s safety and with the study outcome such as stem cell or organ transplantation within the last 5 years, cardiovascular disease, diabetes mellitus, chronic liver disease, chronic kidney disease including dialysis patients, sickle cell anemia or thalassemia, and other forms of immunosuppression (e.g. tumor patients, HIV-infected patients with weakened immune system, iatrogenic immunosuppression) as judged by the study physician according to patient’s
- •reports 12. COVID-19 vaccination planned within study period and/or COVID-19 vaccination within the last 28 days
- •13. Women pregnant (patient reported at pre-SCR and confirmation via pregnancy test at BL) or nursing
- •14. Males or females of reproductive potential not willing to use effective contraception (defined as PEARL index <1 - e.g. contraceptive pill, IUD)
- •15. Alcohol, drug or chemical abuse
- •16. Current participation in another interventional clinical trial
研究者
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