CTRI/2020/05/025397已完成2 期
An open label, multicenter, randomized, controlled clinical trial to evaluate the efficacy and safety of Tablets of purified aqueous extract of Cocculus hirsutus in treatment of moderate COVID -19 disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
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
入选标准
- •Subjects will be included in the study if they meet all of the following criteria:
- •1. Patient who provides written informed consent
- •2. Male or non-pregnant, non-lactating female patient aged >= 18 and <= 75 years (both inclusive)
- •3. Patients with body temperature > 37.3â?? with cough/ shortness of breath
- •4. Patient with moderate COVID-19 infection having either one of the following criteria
- •a. PaO2/ FiO2: 200-300
- •b. Respiratory Rate > 24/min and SaO2/ SpO2 <= 93% on room air
- •5. Patient with RT-PCR confirmed diagnosis of COVID-19
- •6. Patient who is able to take the drug orally and comply with study procedures
- •7. Women of childbearing potential must have a negative urine pregnancy test prior to study entry
排除标准
- •Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria:
- •1. Patient with persistent vomiting
- •2. Patient with known active hepatitis, tuberculosis and definite bacterial or fungal infections
- •3. Patient with altered mental state
- •4. Patient with multiple organ failure requiring ICU monitoring and the treatment
- •5. Patient with respiratory failure and requiring ventilation
- •6. Patient with history of retinopathy or macular degeneration
- •7. Patient with history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •8. Patient with prolonged QTc-interval at baseline ECG ( >450 ms in males or > 470 ms in females)
- •9. Patient taking concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration
- •10. Patient with history of hypersensitivity towards any drug of standard of care
- •11. Patient with history of evidence of chronic interstitial infiltration at imaging
- •12. Patient with history of hospitalization within the past six months for respiratory failure
- •13. Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., heart failure, COPD, hypertension, liver disease, chronic respiratory failure, chronic kidney disease, diabetes, anaemia etc.) that, in the opinion of the Investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results.
- •14. Patient with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.
- •15. Patient who has received specific antiviral drugs ritonavir/ lopinavir, or chloroquine,
- •hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week prior to admission
- •16. Patient who has participated in another investigational study within 3 months prior to enrolment in this study.
- •17. Investigators, study personnel, sponsorâ??s representatives and their first degree relatives.
- •Note: Persistent vomiting is more than three episodes of vomiting in 12 hours, preventing adequate oral
研究者
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