Ivermectin Treatment Efficacy in Covid-19 High Risk Patients (I-TECH Study): A Multicenter Open-label Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 21
- 主要终点
- Number of Patients who Progressed to Severe Disease (Clinical stage 4 or 5)
研究概览
简要总结
This is a multicenter study, which is aimed to investigate the efficacy of the Ivermectin drug in high risk COVID-19 patients. This study will compare Ivermectin treatment efficacy with standard of care alone. Target cohort is mild to moderate symptomatic Covid-19 (Stage 2-3), high risk patients aged 50 years and above with comorbidity, who presented to hospitals within first 7 days of illness.
详细描述
Objectives
Primary Objective:
To assess the effectiveness of Ivermectin in preventing progression of Covid-19 to severe disease (clinical stage 4 or 5), which is defined as severe pneumonia requiring oxygen supplement or critically ill requiring intensive care.
Secondary Objectives:
- To assess the efficacy of Ivermectin in reducing mortality rate among high risk COVID-19 patients.
- To compare difference in resolution of symptoms, chest radiograph, laboratory investigations, ICU admission, mechanical ventilation and length of hospital stay.
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 (Investigator)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RT-PCR or antigen test confirmed COVID-19 cases
- •Aged 50 years and above,with at least one co-morbidities*
- •Within the first 7 days of illness (from symptom onset)
- •Mild to moderate clinical severity
排除标准
- •Asymptomatic stage 1 patients
- •Patients with SpO2 less than 95% at rest. (unless it is an expected baseline SpO2 due to preexisting disease, eg. COAD or pulmonary fibrosis)
- •Patients who need oxygen supplements
- •Patients with concomitant bacterial, fungal, parasitic or other viral infections prior to enrollment.
- •Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal limit)
- •Malabsorptionsyndromeorotherclinicallysignificantgastrointestinaldisease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
- •Pregnant or nursing women.
- •Female patients of reproductive age who cannot consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices from the start of ivermectin administration to 7 days after the end of ivermectin administration.
- •Male patient who has female partner of reproductive age and he cannot agree to use contraception from the start of ivermectin treatment till 7 days after treatment.
- •Patients receiving chemotherapy
- •Patients who received interferon or drugs with reported antiviral activity against COVID-19 (favipiravir, hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, remdesivir) in the past 7 days before enrollment.
- •Patients in whom this episode of infection is a recurrence or reinfection of COVID-
- •Patients who have previously received ivermectin.
- •Patient receiving warfarin or any medications known to interact with ivermectin.
- •Acute medical or surgical emergency (eg. DKA/MI/stroke).
- •Other patients judged ineligible by the principal investigator or sub-investigator.
研究组 & 干预措施
Treatment group
Ivermectin 0.4mg/kg/day for 5 days + standard-of-care
干预措施: Ivermectin 0.4mg/kg/day for 5 days (Drug)
结局指标
主要结局
Number of Patients who Progressed to Severe Disease (Clinical stage 4 or 5)
时间窗: Within 28 days since administered Ivermectin
The number of patients recruited who clinically deteriorated to clinical stage 4 or 5. The differences between two study arms will be assessed via chi-square test. Estimates will be reported in proportions and 95% confidence intervals, together with their corresponding p-values. A logistic regression will also be performed, to enable estimates to be presented in the form of odds ratio and its corresponding 95% confidence interval, potentially adjusting for clinically relevant and statistically significant variable
Time Required for Patients on Treatment Arm to Progressed to Severe Disease (Clinical stage 4 or 5)
时间窗: Within 28 days since administered Ivermectin
The time duration for patients in the treatment arm to deteriorated to clinical stage 4 or 5. The differences between two study arms will be assessed via chi-square test. Estimates will be reported in proportions and 95% confidence intervals, together with their corresponding p-values. A logistic regression will also be performed, to enable estimates to be presented in the form of odds ratio and its corresponding 95% confidence interval, potentially adjusting for clinically relevant and statistically significant variable
次要结局
- Number of Participants with Complete Resolution of Symptoms by day 5 of Enrolment(5 days since time of recruitment)
- Chest Radiograph Changes Pertaining to COVID-19 by Day 5 of Enrolment(5 days since time of recruitment)
- Changes in Serum Absolute Lymphocyte Count(From starting to the end of ivermectin therapy (0 to end of 5th day))
- Changes in Serum Absolute Neutrophil Counts(From starting to the end of ivermectin therapy (0 to end of 5th day))
- Changes in Serum C-Reative Protein (CRP)(From starting to the end of ivermectin therapy (0 to end of 5th day))
- Changes in Serum Creatinine(From starting to the end of ivermectin therapy (0 to end of 5th day))
- Mortality(Through study completion, an average of 28 days)
- Changes in Serum Alanine Aminotransferase (ALT)(From starting to the end of ivermectin therapy (0 to end of 5th day))
- Numbers of Participants Admitted to the Intensive Care Unit(Through study completion, an average of 28 days)
- Numbers of Participants who Require Mechanical Ventilation(Through study completion, an average of 28 days)
- The Length of Hospital Stay (in Calendar days)(Through study completion, an average of 28 days)
- Treatment-Related Adverse Events as Assessed by CTCAE v4.0(From the 6th day of study to the 28th day of study)