Efficacy of Mefloquine as Prophylaxis Against COVID-19: A Placebo-control, Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- The efficacy of Mefloquine
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of Mefloquine as a prophylaxis against SARS-Cov-2 infection in household contacts of COVID 19 confirmed. This study is an open-label, randomized, placebo controlled trial.
A total of 1500 household contacts of COVID-19 confirmed cases who will attend triaging clinic of 5 Egyptian university centers (Helwan university hospital, Ain Shams university hospital, Assiut University Hospital, Fayoum university hospital and Tanta university hospital). The household contacts of COVID-19 confirmed subjects with a decision for home-isolation will be recruited to participate into this study. The recruited subjects from each center will be randomly assigned (locally in that center) into 2 groups (750 volunteer in each group). The 1st group will receive Mefloquine (1100-1650 mg according to body weight), orally, while the other group will receive the same number of placebo tablets (control group). Previous infection will be excluded for all recruited subjects by testing for the presence of anti-bodies against COVID-19 to exclude previous infection. Subjects who are tested negative will be allocated into one of the 2 study groups after randomization, and treatment will be started immediately (either mefloquine or placebo). In addition, a nasopharyngeal swap will be taken from each recruited subject and tested by PCR for COVID-19 to exclude current infection. After having the PCR results, positive cases will be analyzed separately to test for the disease severity.
Neurological and cardiac assessment will be done for all volunteers before recruitment to exclude the presence of any contraindication for Mefloquine intake. Both groups will be followed up clinically to detect any symptom or sign of COVID-19 infection for 2 weeks (during the period of home isolation). Nasopharyngeal swap with PCR for COVID-19 will be done for all included subjects at the end of the follow-up period (14 days), or at the appearance of symptoms or signs suggesting COVID-19 infection.
Primary end points of the study are either:
- End of follow up period (2 weeks)
- Confirmed diagnosis of COVID-19 infection during the study time Initial severity assessment of COVID-19 infection will be done in all infected subjects in both groups to compare severity, in addition to following up of the fate of the infected subjects.
详细描述
Aim:
To evaluate the efficacy and safety of Mefloquine as a prophylaxis against SARS-Cov-2 infection in household contacts of COVID 19 confirmed cases.
Primary objectives:
- Evaluating the role of Mefloquine in preventing SARS-Cov-2 infection
- Evaluation of the side effects that may result from the usage of Mefloquine.
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The participants will be assigned randomly (locally in each center) in a 1:1 ratio to receive either Mefloquine (1100-1650 mg according to body weight), orally, or to receive the same number of placebo tablets (control group).Patients will be sequentially assigned a randomization number that was generated by an independent statistician. Randomization sequence will be provided in pre-sealed envelopes by the central co-ordination committee of the study. Individuals involved in randomization and masking will have no involvement in the rest of the trial.
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
- 是
入选标准
- •This study will include volunteers household contact of COVID 19 confirmed cases who attend the triage clinic in the participating centers. Included persons should be > 18 years old and below 65 years, without any contraindications for Mefloquine usage.
排除标准
- •• People with history of previous confirmed COVID-19 infection.
- •Pregnant and lactating females.
- •People with neuropsychiatric disorders: myasthenia gravis, epilepsy, psychotic disorder, schizophrenia, repeated episodes of anxiety, depression.
- •People with liver cirrhosis or raised liver enzymes.
- •People with arrhythmias or prolonged QT interval on EKG.
- •People with a history of Quinidine-Quinine analogs allergy.
研究组 & 干预措施
Mefloquine arm
Mefloquine hydrochloride will be given in a dose of 1100-1650 mg, according to body weight (BW), splitted into two to three doses.
- 30kg≤BW<45kg: 825mg followed by 275mg after 6-8 hours
- 45kg≤BW<60kg: 825mg followed by 550mg after 6-8 hours
- 60kg≤BW: 825mg followed by 550mg after 6-8 hours and then 275mg 6-8 hours after the second dose
干预措施: Mefloquine as a prophylaxis against SARS-Cov-2 infection in household contacts of COVID 19 confirmed cases (Drug)
Control arm
A similar tablet of non-active gradients was specifically manufactured for the study by EVA Pharma company. The placebo tablets exactly resemble the active treatment mefloquine tablets (the same shape, size and color).
干预措施: Mefloquine as a prophylaxis against SARS-Cov-2 infection in household contacts of COVID 19 confirmed cases (Drug)
结局指标
主要结局
The efficacy of Mefloquine
时间窗: 2 weeks from randomization
will be measured by the detection of the difference in the rate of COVID-19 infection in both groups from the time of randomization
Severity of COVID-19
时间窗: 2 weeks from randomization
for those infected during the study period
次要结局
未报告次要终点
研究者
Mohamed El Kassas
Associate professor and chief of Endemic Medicine Department
Helwan University