An open label, prospective comparative study to evaluate potential of the proposed therapy (Tablet Cefixime 200 mg/Tablet Ivermectin 12 mg/Tablet Montelukast 10mg/Syrup Ascoril LS 5 ml) in adults with mild symptomatic COVID-19 patients receiving the standard treatment (Tablet Cefixime 200 mg/Vitamin C, MVBC/Antacids) of COVID infection.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Compared to standard of treatment receiving in COVID -19 infection, proposed regimen if consumed as an add on therapy prescribed by physician as per the clinical conditions and disease outcome will be efficacious in reducing medically attended lung infection caused by RT-PCR-confirmed COVID-19 virus in COVID Positive adults more than age 18 yrs .
研究概览
简要总结
Thepopulation of adult patients more than the the age of 18 yrs admitted to ahospital or in Quarantine setup with symptoms suggestive of COVID-19 infectionshall be screened for the study. PCR positive insample collected < 96 hours prior to randomization; OR PCR positive insample collected >/= 96 hours prior to randomization, documented inabilityto obtain a repeat sample (e.g. due to lack of testing supplies, limitedtesting capacity, results taking >24 hours, or any documented reason etc.)AND progressive disease suggestive of ongoing SARS-CoV-2 infection shall beconsidered as important criteria for enrollment in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
入选标准
- •1.Patients of both Gender aged more than 18 years old.
- •2.Willing and able to provide written informed consent.
- •3.Patients with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV2 / COVID) infection confirmed by RT Polymerase chain reaction (RT-PCR) test 4.Currently hospitalized and requiring medical care for COVID-19 5.Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening.
排除标准
- •1.Subjects having less than 18 years of age 2.Drug atopy subjects 3.Private positive patients/ Truenaat positive/ Antigen positive 4.Critical comorbities.
结局指标
主要结局
Compared to standard of treatment receiving in COVID -19 infection, proposed regimen if consumed as an add on therapy prescribed by physician as per the clinical conditions and disease outcome will be efficacious in reducing medically attended lung infection caused by RT-PCR-confirmed COVID-19 virus in COVID Positive adults more than age 18 yrs .
时间窗: 14 Days
次要结局
- There will be a reduction in the incidence of hospitalizations attributable to COVID-19 in patients treated with proposed regimen(There will be minimal chances of respiratory failure in patients due to COVID-19 in patients treated with proposed regimen)