Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19
A Randomized, Double-blind, Two Arm, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19.
研究概览
详细说明
Approximately eligible 4000 subjects who are at risk of getting infected with COVID-19 (i.e. person living in same household as COVID-19 patients / healthcare workers providing direct care to COVID-19 patients) will be enrolled in to the study after due consent and based on the eligibility criteria.
Initially, 400 subjects at risk of getting infected with COVID-19 will be enrolled in the study and randomized in 1:1 ratio to receive either Mw (n=200) or placebo (n=200). After the interim analysis from the data of these 400 subjects for safety and efficacy and based on review and recommendations from DSMB / MC, modification in study design, objective or sample size will be considered.
Study duration for each subject will be of 8 weeks.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Chandigarh、印度、160012.
- 招聘中
- Post Graduate Institute of Medical Education and Research
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接触：
- Inderpaul Singh Sehgal, DM (Pulmonary Medicine)
- 电话号码：01722756823
- 邮箱：inderpgi@outlook.com
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首席研究员：
- Inderpaul Singh Sehgal, DM (Pulmonary Medicine)
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Delhi、印度、110029
- 招聘中
- All lndia Institute of Medical Science, Delhi
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接触：
- Sushma Bhatnagar, MD (Anaesthesiology)
- 电话号码：919811326453
- 邮箱：sushmabhatnagar1@gmail.com
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首席研究员：
- Sushma Bhatnagar, MD (Anaesthesiology)
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Madhya Pradesh
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Bhopal、Madhya Pradesh、印度、462024
- 招聘中
- All India Institute of Medical Sciences, Bhopal
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接触：
- Sarman Singh, MD
- 电话号码：917552672317
- 邮箱：director@aiimsbhopal.edu.in
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首席研究员：
- Sarman Singh, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy subjects of either gender, age ≥ 18 years, with recent history of close contact with COVID-19 patients.
- Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit.
- Female subject who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least months post-dosing.
- The subject must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.
Exclusion Criteria:
- Any febrile illness with oral temperature > 100°F within 3 days prior to randomization.
- Subject with past history of COVID-19 infection.
- Pregnant and / or lactating female subjects.
- Presence of any illness requiring hospital referral.
- Any confirmed or suspected immune-deficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency or Individuals on immunosuppressant's as Azathioprine, Cyclosporine, Mycophenolate etc.
- History of allergic reactions or anaphylaxis to Mw or its component.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Suspension of Mw
Intradermal suspension of Mw will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal Mw in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal Mw administered. |
Subjects randomized to Test arm will receive intraderma Mw in divided doses at least 2 cm away from first injection site in the deltoid region.
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安慰剂比较：Placebo
Placebo will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal placebo in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal placebo. |
Subjects randomized to placebo arm will receive intraderma Placebo in divided doses at least 2 cm away from first injection site in the deltoid region.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of subject acquiring COVID-19 infection
大体时间：From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing..
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To compare proportion of subjects acquiring COVID-19 infection between two arms over the time till 8 weeks from administration of 1st dose
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From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing..
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)
大体时间：Till 8 weeks
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Any AE / SAE observed during the study.
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Till 8 weeks
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Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms
大体时间：From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing.
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Whether administration of Mw prevents development of Upper Respiratory Tract Infection (URTI) symptoms in close contacts of COVID-19 patients.
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From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing.
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Number of subject developing severe COVID-19 infection based on ordinal scale
大体时间：From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing
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Whether administration of Mw prevents development of severe COVID-19 infection.
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From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing
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合作者和调查者
调查人员
- 学习椅：Anil Avhad, MBBS、Cadila Pharmaceuticals Limited
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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