An Open Randomized Study of the Effectiveness of the Drug Mefloquine, Tablets 250 mg, Produced by FSUE SPC "Farmzashita" of the Federal Medical Biological Agency, FMBA of Russia (Russia) for the Treatment of Patients With COVID19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- 1st primary endpoint for group 2
研究概览
简要总结
Study of the effectiveness and safety of the drug Mefloquine, tablets 250 mg, produced by FSUE "SPC" Farmzaschita " FMBA of Russia (Russia), in comparison with the drug Hydroxychloroquine, tablets 200 mg, for the treatment of patients with coronavirus infection, in the "off-label" mode, to make a decision on the possibility of expanding the indications for use.
详细描述
Purpose of the study:
Study of the effectiveness and safety of the drug Mefloquine, tablets 250 mg, produced by FSUE "SPC" farmzaschita " FMBA of Russia (Russia), in comparison with the drug Hydroxychloroquine, tablets 200 mg, for the treatment of patients with coronavirus infection, in the "off-label" mode, to make a decision on the possibility of expanding the indications for use.
Study aims:
- To study the efficacy of the drug Mefloquine, tablet 250 mg, for the treatment of patients with coronavirus infection (light and medium-heavy form), the appointment in the "off-label" in comparison with the drug Hydroxychloroquine tablets 200 mg, when administered in the mode "off label".
- To study the effectiveness of the drug Mefloquine, tablet 250 mg, when administered in the mode "off label", in comparison with the drug Hydroxychloroquine tablets 200 mg, when administered in the mode "off label" when applied to a schema for the treatment of patients with severe coronavirus infection.
- Evaluate the safety and tolerability of Mefloquine, 250 mg tablets, and Hydroxychloroquine, 200 mg tablets, for the treatment of patients with coronavirus infection (mild and moderate-severe forms).
- Evaluate the safety and tolerability of Mefloquine, 250 mg tablets, and Hydroxychloroquine, 200 mg tablets, for the treatment of patients with coronavirus infection (severe forms), when used as part of a regimen for the treatment of patients with severe coronavirus infection.
Study design:
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18 years and older COVID19 positive confirmed by PCR, without ARDS and sepsis.
- •Hospitalization of the patient.
- •Signed informed consent for participation in the study.
排除标准
- •The criteria for retiring a volunteer during the screening period are:
- •Revoking informed consent of patients.
- •Non-compliance of the volunteer with the inclusion criteria.
- •First identified the condition and/or disease described in the criteria for inclusion.
- •Positive test for HIV infection, Hepatitis B, C, syphilis.
- •The criteria for early termination of participation of volunteers in the study during the period of use of the study drug are:
- •Withdrawal of informed consent by a volunteer.
- •First identified the condition and/or disease described in the criteria for inclusion.
- •Occurrence of serious adverse events.
- •Adverse events that do not meet the criteria of severity, in the development of which, in the opinion of the researcher, further participation in the study may be harmful to the health or well-being of the volunteer.
- •The need for patients included in the study, antibiotics of the fluoroquinolone group.
- •Administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as gross violations of the Protocol that may affect the results of the study.
- •the Patient receives / needs additional treatment that may affect the outcome of the study or the patient's safety
- •Individual intolerance to research drugs
- •Erroneous inclusion (for example, the patient was included in violation of the criteria for inclusion/non-inclusion of the Protocol).
研究组 & 干预措施
group 1 cohort 1
80 patients who receive Mefloquine prescribed according to the following scheme:
- 1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day - 1 tablet every 8 hours.
- Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day - 1 tablet every 12 hours.
- 3rd - 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time.
干预措施: Mefloquine (Drug)
group 1 cohort 2
80 patients who receive Hydroxychloroquine prescribed according to the following scheme:
• 1st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day; 2nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.
干预措施: Hydroxychloroquine (Drug)
group 2 cohort 1
A concomitant therapy consisting of Mefloquine in conjunction with azithromycin and tocilizumab will be given for 80 patients. Dosage of Mefloquine is same as for group 1 cohort 1.
干预措施: Mefloquine + azithromycin + / - tocilizumab (Combination Product)
group 2 cohort 2
A concomitant therapy consisting of Hydroxychloroquine in conjunction with azithromycin and tocilizumab will be given for 80 patients. Dosage of Hydroxychloroquine is same as for group 1 cohort 2.
干预措施: Hydroxychloroquine + azithromycin + / - tocilizumab (Combination Product)
结局指标
主要结局
1st primary endpoint for group 2
时间窗: up to 10 days
The period of clinical recovery.
2nd primary endpoint for group 2
时间窗: through study completion, an average of 3 months
Frequency of fatal outcomes associated with coronavirus infection disease (COVID19)
1st primary endpoint for group 1
时间窗: up to 10 days
The number of patients with development of respiratory failure requiring transfer to the ICU.
2nd primary endpoint for group 1
时间窗: up to 10 days
The period of clinical recovery.
次要结局
- 1st secondary endpoint for group 1(on days 5 and 10)
- 2nd secondary endpoint for group 1(on day 10)
- 3d secondary endpoint for group 1(up to 10 days)
- 4th secondary endpoint for group 1(up to 10 days)
- 5th secondary endpoint for group 1(up to 10 days)
- 6th secondary endpoint for group 1(up to 10 days)
- 1st secondary endpoint for group 2(on days 5 and 10)
- 2nd secondary endpoint for group 2(up to 10 days)
- 3d secondary endpoint for group 2(up to 10 days)
- 4th secondary endpoint for group 2(up to 10 days)
- 5th secondary endpoint for group 2(up to 10 days)
- 6th secondary endpoint for group 2(up to 10 days)
研究者
Tatyana Astrelina
MD PhD, DSc (medicine), Head of Center for Biomedical Technologies State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia
Burnasyan Federal Medical Biophysical Center