Ivermectin and Doxycycline in Combination or Ivermectin Alone for the Treatment of Adult Bangladeshi Patients Hospitalized for COVID-19: a Randomised, Double-blind, Placebo-controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Remission of cough
研究概览
简要总结
Burden:
Initial outbreak of corona virus disease 2019 (COVID-19) was reported from Wuhan, China in early December 2019.Presently known to be caused by a novel beta-corona virus, named as Severe acute respiratory syndrome corona virus 2 ( SARS-CoV-2).
World Health Organization (WHO) declared a pandemic on March.
The clinical characteristics of COVID-19 include respiratory symptoms, fever, cough, dyspnoea and pneumonia
Infected individuals exhibit:
- Mostly mild illness (80% +) recover without any treatment (~80%)
- Moderate illness that needs hospitalization and recovers after standard
- supportive treatment (~14%)
- Critical illness (~5%) needs ICU support
- Death (1-2% )
COVID-19 has now spread >210 countries and territories globally. SARS-CoV-2 is a respiratory virus which spreads primarily through droplets generalized when an infected person coughs or sneezes or through droplets of saliva or discharge from the nose.
Symptomatic management remains the mainstay of treatment strategy. Mortality appears to be more common in older individuals and those with co-morbidities, such as chronic lung disease, cardiovascular disease and diabetes. Young people with no comorbidities also appear to be at risk for critical illness including multi-organ failure and death. Seen more in Bangladesh between 21-40 yrs of age.
Knowledge Gap:
There is no specific treatment against this new virus that WHO has officially declared until now.There are many pharmacologic therapies that are being used or considered for treatment of COVID-19. National Guidelines on Clinical Management of Corona virus Disease 2019 (Covid-19): V 5.0 date 9th April 2020) CDC, DGHS, GoB
Thus an RCT is urgently needed in Bangladesh: Based on recent literatures on Rx studies in COVID-19 patients from other countries as well as its availability & affordability of those repurposed medicines
详细描述
Objectives:
General Objective:
The aim of the study is to evaluate efficacy and safety of ivermectin in combination with doxycycline or ivermectin alone for the treatment of hospitalized SARS-CoV-2 infected adult Bangladeshi COVID-19 +ve patients and to compare with placebo; where all three arms will receive the standard care of treatment of COVID-19 infected patients in the hospital. By successful demonstration of the safety and efficacy of these repurposed medicines, it may have the potential to play an important role in the treatment of COVID-19+ve patients.
Specific Objective:
- Duration of the virological clearance rate
- Days required for remission of fever and cough
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Allergy to ivermectin or doxycycline; or other contraindications to any of the study medications
- •History of chronic heart disease (IHD, heart failure, documented cardiomyopathy etc)
- •History of chronic liver disease (SGPT value more than 3 times of normal value)
- •History of chronic kidney disease (S. Creatinine for male >1.3 mg/dL or >115 µmol/L and for female >1.2 mg/dL or >106.1 µmol/L)
- •Pregnant or lactating women
- •Participated in any other clinical trial within last 4 weeks
- •H/o received Ivermectin/Doxycycline within last 7 days
研究组 & 干预措施
Tab Ivermectin +Cap Doxycycline
200 mcg/kg (12 mg tablet) ivermectin (IVERA) single dose and 200 mg stat doxycycline day-1 followed by 100mg doxycycline 12hrly for 4 day (i.e. day2-day5)
- Placebo one tablet D2-5
干预措施: Ivermectin + Doxycycline + Placebo (Drug)
Tab Ivermectin
Ivermectin - 200 mcg/kg (12 mg tablet) once per day D1-D5
- Placebo two tablets D1 followed by Placebo one tablet D2-5
干预措施: Ivermectin + Placebo (Drug)
Placebo
Drug: Placebo
3 Placebo tablets D1 followed by 2 tablets D2-5
干预措施: Placebo (Drug)
结局指标
主要结局
Remission of cough
时间窗: within 7 days after enrollment
• Remission of cough: No signs of cough showing respiratory rate within 12-20/ min, on day7
Virological clearance
时间窗: within 7 days after enrollment
• Presence of virus will be negative on Day 7 detected by RT PCR
Remission of fever
时间窗: within 7 days after enrollment
• Body temperature will be \< 37.5 C by day 7 detected by Infrared thermometer
次要结局
- Patients requiring oxygen(within 7 days after enrollment)
- Patients failing to maintain SpO2 >93% despite oxygenation(within 7 days after enrollment)
- Number of days on oxygen support(within 7 days after enrollment)
- Duration of hospitalization(within 14 days after enrollment)
- All causes of mortality(within 14 days after enrollment)