EUCTR2022-001097-64-LT进行中（未招募）1 期
An open-label, randomized, parallel-controlled, phase II clinical trial to evaluate the tolerability, efficacy and safety of Aesculus Hippocastanum L seed extract in COVID-19 patients with mild pneumonia - Aesculus Hippocastanum L seed extract in Covid-19 patients
AB Švencioniu vaistažoles0 个研究点目标入组 60 人开始时间: 2022年4月22日最近更新:
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
- 60
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. Patient age: 18 to 65 years
- •2. The patient gave informed consent; patients who understand the essence of the study
- •and can independently give the informed consent
- •3. A positive SARS-CoV-2 sample (nasopharyngeal swab) was determined by RT-PCR
- •4. Patients diagnosed with mild pneumonia with no identified lesions by chest X-ray
- •5. Patients who have a fever
- •6. Premenopausal women who had a negative pregnancy test
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Fever 37.5 °C more than 14 days after the onset of fever
- •2. Patients with SpO2 less than 95 % and not treated with O2 therapy
- •3. Patients with suspected co-fungal infection
- •4. Patients with congestive heart failure
- •5. Patients with severe hepatic impairment.
- •6. Patients with renal insufficiency
- •7. Patients with impaired consciousness, such as those with dementia
- •8. Pregnant women
- •9. Women patients intending to breast-feed
- •10. Patients with a gout or with hyperuricemia
- •11. Patients taking immunosuppressants, cancer patients
- •12. Patients with a recurrent SARS-CoV-2 infection
- •13. Patients with epilepsy, bronchial asthma
- •14. Unstable angina pectoris or myocardial infarction within 30 days prior to screening
- •15. Patients participating in another clinical trial or if participation finished before 3
- •16. Patients have blood purification therapies (hemodialysis, hemofiltration,
- •hemadsorption, plasma exchange, plasma adsorption, peritoneal dialysis, etc.)
- •17. Patients who develops a disease with diarrhea syndrome
- •18. Other patients who have been assessed as unfit by the principal investigator or
- •designated physician
研究者
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