CTRI/2021/04/032989已完成未知
A study to assess the safety and efficacy of pHoxvedic, an ayurvedic nasal drop in prevention COVID-19 infection in healthy high-risk healthcare professionals
RAPHAEL LABS LTD0 个研究点目标入组 640 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 640
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. Healthcare professionals at high risk of SARS-CoV-2 exposure.
- •2. Normal or clinically insignificant findings during screening, medical
- •history, medical examination, laboratory evaluations.
- •3. Subjects agree to refrain from taking over the counter products
- •intended to prevent, intervene in, or treat colds/flu, starting at study
- •entry and continuing through out study.
- •4. Able to give voluntary informed consent for participation in the study.
排除标准
- •1. Laboratory confirmed SARS-CoV-2 positive.
- •2. Laboratory confirmed IgG positive for SARS-CoV-2
- •3. Proven history of SARS-CoV-2 infection (laboratory confirmation by PCR
- •4. Previous participation in any clinical trial of a SARS-CoV-2 candidate
- •5. Subjects, who have been partially or fully vaccinated against SARS-CoV2 with any approved vaccine.
- •6. History of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy.
- •7. Subjects with confirmed immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy.
- •8. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, psychiatric, or immunological disorder or any other
- •symptoms or disorder that may interfere with study objectives as per Principal Investigator discretion.
- •9. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration
- •during the study.
- •10. SARS-CoV-2 vaccine planned to be administered during the study
- •11. Pregnant and lactating women.
- •12. Participation in another clinical trial in the past 3 months.
- •13. History of drug / alcohol abuse.
- •14. Unable to complete the daily symptom tracker.
- •15. Unable/unwilling to follow local standard SARS-CoV-2 infection prevention measures e.g., PPE, face shield, masks etc.
- •16. Any nasal/sinus anatomy that will make use of the nasal spray difficult
- •or is symptomatic to the point where it will interfere with the study.
研究者
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