CTRI/2020/04/024883已完成4 期
Randomized controlled Single blinded prospective multi centre clinical trial toinvestigate the safety and efficacy of ZingiVir-H as an adjuvant therapy in hospitalized adultsdiagnosed with coronavirus disease 2019 (COVID-19)
Pankajakasthuri herbal research foundation0 个研究点目标入组 116 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 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
入选标准
- •1. Patients of both sexes aged from 18 years to 60 years old.
- •Willing and able to provide written informed consent prior to performing study
- •procedures by the subject or legal guardian willing and able to provide written informed
- •consent prior to performing study procedures
- •3. Patients with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection
- •confirmed by RT Polymerase chain reaction (RT-PCR) test between 1 and 120 Hours
- •before randomization
- •4. Currently hospitalized and requiring medical care for COVID-19
- •5. Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
- •6. Radiographic evidence of pulmonary infiltrates
排除标准
- •Candidates for the study will be excluded if ANY of the following criteria are present:
- •1. Subject or Authorized Representative is unable to provide informed consent
- •2. Subject is pregnant or breastfeeding ladies
- •3. Subject is of childbearing potential and has a positive pregnancy test since admission to
- •the hospital
- •4. Subject is < 18 years of age
- •5. Subject has a known allergy to herbal compounds or ZingiVir-H or any components of
- •the drug product
- •6. Subject has had previous treatment with ZingiVir-H
- •7. Body weight >= 175 kg
- •8. Intra-thoracic or intra-abdominal surgery within the 12 hours prior to consent, or ongoing
- •impairment of hemostasis as a result of one of these procedures
- •9. A history of head trauma, spinal trauma, or other acute trauma with an increased risk of
- •10. Cerebral Vascular Accident (CVA) or Intracerebral Arteriovenous Malformation (AVM),
- •cerebral aneurysm, or mass lesions of the central nervous system or melena,
- •hematemesis.
- •11. Inability to take oral medication
- •12. Prolonged QTc-interval in baseline ECG ( >500 ms)
- •13. History of solid organ, allogeneic bone marrow, or stem cell transplantation.
- •14. Severe renal failure characterized by chronic or acute need of hemodialysis,
- •hemofiltration or peritoneal dialysis
- •15. Need of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics during the
- •treatment period.
- •16. Participation in another research study involving an investigational agent within 30 days prior to consent
研究者
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