A Pilot Study for COVID-19 Outpatient Treatment With the Combination of Ivermectin-azithromycin-cholecalciferol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Viral clearance
研究概览
简要总结
As the world faces COVID-19, the search for effective treatments against the disease and its complications has turned its gaze to drugs that are classically used in other infectious diseases. Some drugs are being examined for the recent evidence on its effects on viral replication and inflammation, one is Azithromycin, used to treat a wide variety of bacterial infections, Ivermectin, an anti-parasitic drug and the other is Cholecalciferol to increase serum concentration of 25-hydroxyvitamin D.
详细描述
The aim of the study is to assess the efficacy of Ivermectin-Azithromycin-Cholecalciferol combination in COVID-19 in early stages of the disease with outpatient management.
Enrollment of subject into the trial shall only occur after providing written permission to voluntarily participate into the study by signing and dating the informed consent form before starting any trial related treatment. 30 cases of COVID-19 will be enrolled into the trial with a 3:1 proportion, divided into two groups. First group with confirmed cases of COVID-19 shall be treated with Ivermectin (6mg once daily in day 0,1,7 and 8) plus Azithromycin (500mg once daily for 4 days) plus Cholecalciferol (400 IU twice daily for 30 days) in an outpatient regimen. The second group with confirmed cases of COVID-19 who refused treatment were shall be allocated as the control group for monitoring.
Test for virus at day 1 and 14 from beginning of trial drug started for the outpatient regimen.
Clinical symptoms, oxygen saturation and oxygenation index will be monitored every day of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed infection of SARS-CoV2 virus
- •Mild COVID-19
- •Symptoms of respiratory illness
- •Fever (T >38 °C)
排除标准
- •Allergy to any of the drugs treatment
研究组 & 干预措施
Combination
Ivermectin (6mg once daily in day 0,1,7 and 8) plus Azithromycin (500mg once daily for 4 days) plus Cholecalciferol (400 IU twice daily for 30 days).
干预措施: Ivermectin (Drug)
Combination
Ivermectin (6mg once daily in day 0,1,7 and 8) plus Azithromycin (500mg once daily for 4 days) plus Cholecalciferol (400 IU twice daily for 30 days).
干预措施: Azithromycin (Drug)
Combination
Ivermectin (6mg once daily in day 0,1,7 and 8) plus Azithromycin (500mg once daily for 4 days) plus Cholecalciferol (400 IU twice daily for 30 days).
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Viral clearance
时间窗: 14 days
Test for virus at day 1 and 14 from beginning of trial drug started
次要结局
- Symptoms duration(14 days)
- SpO2/FiO2(14 days)
- SpO2(14 days)
研究者
Guadalupe Espitia Hernandez, MD, PhD
Investigator
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado