ISRCTN13311119已完成2 期
The efficacy and safety of Siddha Treatment in Symptomatic Participants with novel coronavirus infectious disease (COVID-19): A Multicenter, Randomized, Open-Label, Active-controlled Randomised Clinical Trial
Eminentlabs GmbH0 个研究点目标入组 116 人开始时间: 2020年4月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
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. Aged between 18 and 75 years
- •2. Laboratory-confirmed COVID-19
- •3. Presence of any 2 symptoms of COVID-19: fever, cough, sore throat, myalgia, fatigue, headache or dyspnea
- •4. Not currently hospitalized or under immediate consideration for hospitalization. Hospitalization is defined as admission where patients require parenteral/Intravenous (IV) medications or IV fluids, oxygen or ventilatory support in hospital. Isolation or quarantine inside the hospital premises alone will not be considered as hospitalization.
- •5. Meets clinical features of the following grades of severity:
- •5.1. Suspected/confirmed cases in COVID Care Centres, clinically assigned as mild and very mild, presenting with fever and/or upper respiratory tract illness
- •5.2. Suspected/confirmed cases in Dedicated COVID Health Centres, clinically assigned as moderate, presenting with pneumonia with no signs of severe disease (Respiratory Rate 15 to 30 breaths/minute, SpO2 90%-94%)
- •6. Willing to practice contraception during the entire study treatment period and for 3 months after the last treatment of IMP is administered, using either double barrier contraception or sexual abstinence (when this is in line with the preferred and usual lifestyle of the participant)
- •7. Patients or their legal representatives have personally signed and dated signed the informed consent form (ICF) before completing any study-related procedure, which means before any assessment or evaluation that would not have formed a part of his normal medical care
- •8. Willing to adhere and comply with the protocol-related procedures
- •9. Willing to take Siddha drug regimen for COVID-19 infection
- •10. Willing to not participate in other clinical studies within 30 days after the last administration from the first administration of the study drug
排除标准
- •1. Viral pneumonia with cause other than SARS-CoV-2
- •2. Severe or critical COVID-19 infection
- •3. Taken antibiotics/antivirals in the past 1 week
- •4. History of Asthma, COPD or any other chronic lung disease
- •5. Active malignancy
- •6. Received organ transplantation in the past 6 months or planning surgery
- •7. Unable to take food or drugs orally
- •8. Malabsorption or GI abnormalities which may affect drug absorption
- •9. Severe underlying diseases affecting survival, including but not limited to: blood diseases, dyscrasia, active bleeding, severe malnutrition, etc.
- •10. Subjects who are pregnant or lactating, have a pregnancy plan (including plans for sperm donation or egg donation), or who may fail to take effective contraceptive measures within the next 6 months
- •11. Allergic constitution, or known allergy to investigational products
- •12. Testing positive for HIV, Hepatitis B and Hepatitis C at screening
- •13. Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal.
- •14. Requiring Extracorporeal Life Support Program (ECLS), i.e. Extracorporeal Membrane Oxygenation (ECMO), Extracorporeal carbon dioxide removal (ECCO2R) or Registered Respiratory Therapist (RRT)
- •15. Life expectancy < 48 h
研究者
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