A randomized, double blind, placebo controlled, comparative study to investigate the efficacy of N-acetylcysteine in COVID-19 patients with standard therapy.
试验速览
- 阶段
- 不适用
- 状态
- Other
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 2.Rate of cure from the disease as measured by negative results of RT-PCR test on nasopharyngeal swabs
研究概览
简要总结
| COVID-19 is a universal emergency, and is characterized by high morbidity and mortality. In this project we aim to examine the effect of N-acetycysteine on alleviating signs and symptoms of SARS CoV-2 infection. This study will be a randomized, double blind, placebo-controlled clinical trial conducted in the corona isolation wards of Index hospital, Indore which is already designated as ‘Red Zone’ hospital for treatment of the COVID patients. |
Subjects:
100 patients will be selected from the admitted patients undergoing COVID-19 treatment in corona ward after signing the informed consent. Stratified patients will be randomly assigned in either NAC group (n=50) or control group (placebo) (n=50). The NAC group will receive N-acetyl cysteine along with the conventional treatment for SARS CoV-2 infection whereas placebo group will be given sugar coated tablets added up with regular conventional treatment.
The symptomatic treatment containing of an expectorant, and will be given to both the groups as and when required. Diary record of all the medications given will be maintained. Patients in the NAC group will receive 600mg/day oral NAC doses for 10 days. Patients will be monitored for the incidence of NAC related side effects and drug interaction. Increase and decrease of NAC doses will be done during the pilot experiment. RT PCR of nasopharyngeal swabs will be performed. Data will be recorded and analyzed for primary and secondary outcomes and interpretations will be made in concern with effectiveness of NAC in COVID treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 10.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •patients of both genders who aged between 10 years to 55 years with confirmation of COVID-19 infection through RT-PCR test.
- •Mild to moderate severity of disease who are willing to participate in study by giving written informed consent.
排除标准
- •seriously ill patients requiring ventilators support.
- •Children below 10 years, adults > 55 years of age.
结局指标
主要结局
2.Rate of cure from the disease as measured by negative results of RT-PCR test on nasopharyngeal swabs
时间窗: 5-7days from start of dose administration
1.Effect of NAC in the study group on alleviating patient’s signs and Symptoms of COVID-19 in forms of severity and duration.
时间窗: 5-7days from start of dose administration
次要结局
- 1.Incidence of the adverse effects in both the group.(2.Association of age and gender with the clinical outcome in COVID-19 patients.)