The Safety and Efficacy Outcome of Ivermectin Plus Doxycycline in Treatment of RT-PCR Positive Adult Mild Covid-19 Cases: a Randomized Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 188
- 主要终点
- Time to outcome measure of fever (<100.40F)and cough
研究概览
简要总结
A randomized double blind control trial will be done. Total 188 Covid-19 patients will be enrolled in this trial who are RT-PCR confirmed case of mild cases. Before enrollment, base line investigations will be done and as per eligibility criteria 188 (one hundred eighty eight) patients of mild symptoms will be selected by random sampling. Ninety four diagnosed patients (Group-A) of Covid-19 will be in the experimental group and 94 Covid-19 diagnosed patients (Group-B) will be in the control group.
Group -A will be given combination treatment of Tab Ivermectin and Cap Doxycycline along with standard therapy and Group -B will be treated by standard therapy with placebo.
Follow up will be done every day in both group with all the parameters as stated above and will be documented.
On 5th day of treatment, if fever subsides final outcome will be measured by result of RT-PCR test preferably from one designated lab with sample of nasal swab for all. Subject to RT-PCR test negative result again on 6th day another RT-PCR test will be done at 24 hours apart. But if RT-PCR test result remain positive on 5th day, again on 10th day same test is to be done and also on 11th day subject to test result as negative on 10th day.
Death of the patients will be documented as well. Regarding safety issues of the drugs we shall monitor for any SAE and would report to the DSMB for proper management guideline
详细描述
A randomized double blind control trial will be done. Total 188 Covid-19 patients will be enrolled in this trial who are RT-PCR confirmed case of mild cases. Before enrollment, base line investigations will be done and as per eligibility criteria 188 (one hundred eighty eight) patients of mild symptoms will be selected by random sampling. Ninety four diagnosed patients (Group-A) of Covid-19 will be in the experimental group and 94 Covid-19 diagnosed patients (Group-B) will be in the control group.
Group -A will be given combination treatment of Tab Ivermectin and Cap Doxycycline along with standard therapy and Group -B will be treated by standard therapy with placebo.
Follow up will be done every day in both group with all the parameters as stated above and will be documented.
On 5th day of treatment, if fever subsides final outcome will be measured by result of RT-PCR test preferably from one designated lab with sample of nasal swab for all. Subject to RT-PCR test negative result again on 6th day another RT-PCR test will be done at 24 hours apart. But if RT-PCR test result remain positive on 5th day, again on 10th day same test is to be done and also on 11th day subject to test result as negative on 10th day.
Death of the patients will be documented as well. Regarding safety issues of the drugs we shall monitor for any SAE and would report to the DSMB for proper management guideline
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects within age group 18 years to onward
- •With either sex, male or female
- •Confirmed mild cases of Covid-19 by RT-PCR test
- •patients who are classified as mild cases with typical symptoms
- •patients who are not already treated with any other antiviral drugs
排除标准
- •Patients who are asymptomatic,moderate, severe and critically ill (resting respiratory rate more than 30, O2 saturation below 93%).
- •Patients with co-morbidities (diabetes, hypertension, chronic liver and kidney diseases obesity, pre-existing ischemic heart disease, COPD,other severe disease)
- •Patients with pregnancy and on lactation
- •Patients with previous allergic reaction to Ivermectin or Doxycycline
研究组 & 干预措施
Placebo plus standard care
- Standard symptomatic and supportive treatment with placebo; Standard treatment includes tab paracetamol, tab antihistamine, tab montelukast will be mostly used as symptomatic treatment, vitamin C and vitamin D as supplements.
Placebo (1) 2 tab stat then again 2 tab after 12 hours Placebo (2) will be given as 1+0+1 for 10 days
干预措施: Placebo (Other)
Ivermectin plus Doxycycline plus standard care
Tab Ivermectin (6mg): 12mg first dose then one more dose of 12mgafter 12 hours 2) Cap. Doxycycline (100mg): 1+0+1 after meal for 10 days. To be taken with half glass of water and sit up for 20 minutes 3) Standard symptomatic and supportive treatment; Tab paracetamol, tab antihistamine, tab montelukast will be mostly used as symptomatic treatment, vitamin C and vitamin D as supplements
干预措施: Ivermectin and Doxycycline (Drug)
结局指标
主要结局
Time to outcome measure of fever (<100.40F)and cough
时间窗: 10 days
Outcome measure of symptoms associated with covid, fever and cough
Negative RT-PCR test on day 5 of treatment
时间窗: 10 days
If the result of RT-PCR test is negative, then 24 hours apart another RT-PCR test will be done. Subject to 2 consecutive negative tests patient will be declared as cured
次要结局
未报告次要终点