CTRI/2021/03/032471已完成不适用
A Non-Interventional, Retrospective, Observational Study to Analyze Safety, Efficacy and Tolerability of THINQURE 20 in COVID-19 Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Reduction in viral load from baseline to end of study visit.
研究概览
简要总结
A Non-Interventional, Retrospective, Observational study to analyze safety, efficacy and tolerability of THINQURE 20 in COVID-19 patients.
Base on data available we want to analyze THINQURE 20 in COVID-19 patients.
Based on data analysis we will go for a pivotal study
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •We will consider the following criteria for retrospective analysis.
- •Male or Female subjects of age 18 to 75 years (both inclusive).
- •Subjects diagnosed with COVID-19 by RT-PCR.
- •Patients provided oral & nasal swabs for test
- •Females of child-bearing potential (i.e., who were not chemically or surgically sterilized or who were not post-menopause) must have had a negative urine pregnancy test.
- •Females of child-bearing potential who have used a medically accepted method of contraception that was considered reliable in the judgment of the investigator.
- •Subjects who have taken Thinqure 20 as prescribed by Investigator.
排除标准
- •Subjects were excluded on the following basis:
- •Patients with a history of intracranial bleeding
- •Patients without a completed medical history
- •Patients, who were suffering from any haemoglobinopathies such as thalassemia that could interfere with oxygen carriage in the blood.
- •Patients, who were smokers or consumed alcohol.
- •Patients, who were suffering from active malignancy along with squamous cell or basal cell skin cancer.
- •Females who were not ready to use acceptable contraceptive methods during the course of study.
结局指标
主要结局
Reduction in viral load from baseline to end of study visit.
时间窗: Day 1 to Day 5
次要结局
- The assessment of safety and tolerability of Investigational Product.(Day 1 to Day 5)
研究者
研究点 (1)
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