Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19
2020年12月20日 更新者：Cadila Pharnmaceuticals
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.
This clinical trial is a randomized, blinded, two arms, placebo controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice to prevent 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
介入性
注册 (预期的)
4000
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Sanjay Patel, MBBS
- 电话号码：270 +912714221481
- 邮箱：sanjay.p@cadilapharma.co.in
研究联系人备份
- 姓名：Ashish Amarsheda, M.Pharm
- 电话号码：+919898073861
- 邮箱：ashish.a@cadilapharma.co.in
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
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
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
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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.
|
|
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 |
|---|---|---|
|
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
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Anil Avhad, MBBS、Cadila Pharmaceuticals Limited
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年6月30日
初级完成 (预期的)
2021年3月30日
研究完成 (预期的)
2021年5月30日
研究注册日期
首次提交
2020年4月16日
首先提交符合 QC 标准的
2020年4月16日
首次发布 (实际的)
2020年4月20日
研究记录更新
最后更新发布 (实际的)
2020年12月22日
上次提交的符合 QC 标准的更新
2020年12月20日
最后验证
2020年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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