CTRI/2020/09/028044招募中4 期
A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19
Windlas Biotech Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
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
- •1.Male or female subjects of >=18 to 60 years of age both inclusive
- •2.Subjects willing to give informed consent and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •3.Confirmed case of COVID-19 infection by RT-PCR and mild and moderate (without oxygen therapy or assisted ventilation) cases of COVID-19. Scores of 2-4 on the WHO Clinical Progression Scale
- •4.Time interval between symptoms onset and randomization of no more than 7 days
- •5.One or more of the following symptoms:
- •Sore throat
- •Nasal congestion
- •Loss of smell
- •Loss of taste
- •6.Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
排除标准
- •1. Subjects with history of severe infections (pneumonia, septicemia, etc.), severe cardiac or pulmonary diseases, or received immunosuppressive therapy or other investigational drugs within the previous 30 days of screening
- •2. Known or suspected hypersensitivity to Artemisinin
- •3. Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study
- •4. Men who are unwilling to use contraception while receiving investigational product
- •5. Subjects with history of severe disease other than COVID-19 which is expected to prevent compliance with the present protocol
- •6. Subjects with history of severe renal and hepatic impairment. (creatine >=2 mg/dl; liver enzymes and bilirubin 2.5 times ULN; alkaline phosphatase 1.5 times ULN)
- •7. Recent treatment with Artemisinin or Artemisinin based antimalarials in the past 7 days
- •8. Known history of failure to control systemic fungal, bacterial or viral infection
- •9. Patients with the history of following co-morbidities: diabetes, hypertension with or without cardiac symptoms, morbid obesity with diabetes and/or hypertension or any other metabolic syndrome
- •10. Subjects with known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection
- •11. Have a history of neurological or psychiatric disorders, including epilepsy or dementia
- •12. Subjects for whom ventilator support is required at screening
- •13. Patients not willing to stay in hospital for 5 days of isolation following diagnosis of Covid-19
- •14. Subjects not willing to give their informed consent to participate in the clinical trial
- •15. According to the investigator judgment there are concomitant diseases with a serious safety hazard or affect the subject
- •16. Using other experimental drugs or participating in other clinical trials in the prior one month
研究者
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