Role of Ivermectin and Colchicine in Treatment of COVID-19: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- duration and number of symptoms
研究概览
简要总结
Corona virus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), a new corona virus that emerged in Wuhan, China, in December 2019. It spread rapidly throughout the world causing great mortality. Till date, there is no specific treatment for COVID-19; Ivermectin and colchicine were proposed as therapeutic options for treatment of COVID-19. Our randomised controlled clinical trial aims to assess the effectiveness of ivermectin and colchicine for treating COVID-19.
详细描述
Patients will be selected from Triage/COVID-19 Outpatient Clinic and every patients will be subjected to the following:
- Clinical history will be obtained about socio-demographic data such as age, gender, residence, marital status, smoking history...etc, medical history including (weight, current medication, symptoms (onset, course, duration) and presence of Co-morbidities.
- Full general examination including: temperature, heart rate, blood pressure, respiratory rate and oxygen saturation.
Suspected patients according to CDC criteria will be subjected to laboratory and radiological confirmation with (PCR-COVID-19, Complete Blood Count, CRP, Ferritin and D-Dimer) and High resolution CT chest.
After confirmation of the diagnosis and patients are classified as moderate with laboratory and radiological findings.
o Grouping: All patients enrolled in the study according the calculated sample size will be equally divided randomly into 3 groups using sealed envelope contain code for each group.
- Group A (Ivermectin group): COVID-19 patients with moderate severity who will receive standard treatment according to the protocol of the Egyptian Supreme Council of University Hospitals plus Ivermectin in the form of oral tablets e.g. (Iverzine 6mg) (200 mcg/kg/day) (4 tablets in the first day and then 2 tablet in the second and third day) on an empty stomach (Kaur et al., 2021).
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
- Single (Participant)
盲法说明
Using sealed envelopes for either participants or controls
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged (18-64) years with confirmed criteria of COVID-19 infection.
- •Moderate Cases: Patients have symptoms (such as fever, respiratory tract symptoms), pneumonic manifestations can be seen in chest imaging and oxygen saturation more than 94% (Egyptian Ministry of Health and Population, 2020).
排除标准
- •Pregnant or lactating female.
- •Any co-morbidities (DM, hypertension, Asthma......etc.).
- •Participants receiving immunosuppressive or chemotherapy drugs.
- •Active malignancy.
研究组 & 干预措施
Ivermectin group
received standard treatment plus Ivermectin in the form of oral tablets (0.2 mg/kg/day) single dose on an empty stomach for three successive days
干预措施: Ivermectin Tablets (Drug)
Colchicine group
received standard treatment plus Colchicine 0.5mg tablets (3times/day after meal for 3 days then twice daily for 4 days)
干预措施: Colchicine 0.5 MG (Drug)
Control group
received the standard treatment according to the protocol of the Egyptian Supreme Council of University Hospitals (http://scu.eg/pages/university_hospitals) (Vitamin C 500mg tablet twice daily, Vitamin D3 2000-4000 IU/day, Zinc 75mg tablet once daily for two weeks and needed protocol of management according to case assessment and severity)
干预措施: Standared managment (Drug)
结局指标
主要结局
duration and number of symptoms
时间窗: one month
Participants were followed up twice weekly for one month. They were called by phone to ask about their symptoms e.g: they were asked about symptoms relief, number of symptoms, duration of symptoms e.g cough, fever (temperature measurement by thermometer)
Concentration of inflammatory markers (CBC, CRP, Ferritin and D-dimer )
时间窗: one month
Patients were asked to do inflammatory markers (CBC, CRP, Ferritin and D-dimer ) in the first 5 days as initial labs . Two weeks later, patients were followed up in the clinic. They were asked to repeat the primary investigations (CBC, CRP, Ferritin and D-dimer). After one month of symptoms onset, patients were followed up in the clinic and the previous investigations (CBC, CRP, Ferritin and D-dimer) were re-tested
need for oxygen inhalation
时间窗: one month
Patients were asked to measure oxygen saturation daily and according to the measurement, the need for oxygen was determined.
need for hospital admission, ICU admission, mechanical ventilation and mortality.
时间窗: one month
Patients were assessed for the need of hospital admission, ICU admission, mechanical ventilation or if mortality documented. all these measures were done according to oxygen saturation measurement , investigations and assessment of symptoms if they improve or deteriorate
次要结局
未报告次要终点
研究者
hemat abdelsalam ahmed
Assistant lecturer of family medicine
Ain Shams University