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Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically Ill

2020年12月20日 更新者：Cadila Pharnmaceuticals

A Randomized, Double-blind, Two Arm, Controlled Clinical Trial to Compare the Efficacy and Safety of Mycobacterium w (Mw) Administered Along With Standard of Care Versus Placebo Administered Along With Standard of Care, in Adult, COVID 19 Positive Patients Hospitalized But Not Critically Ill.

This is a randomized, double blind, two arms, placebo controlled, clinical trial to study to evaluate the the safety and efficacy of Mycobacterium w in combination with standard of care versus placebo with standard of care for preventing the progression of COVID-19 disease and for reduction in transfer to ICU in COVID-19 infected patients admitted to the hospital.

研究概览

地位

未知

条件

干预/治疗

详细说明

Total 480 hospitalized adult eligible patients will be randomized in 1:1 ratio to receive either Mw+SOC or placebo+SOC for first 3 days post-randomization.

Daily clinical evaluation of patient will be performed till discharge from hospital or till ICU admission.

Study duration for each patient will be approximately up to 28 days, or discharge from hospital or transfer to ICU, whichever is earlier.

研究类型

介入性

注册 (预期的)

480

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。

学习地点

  • 印度
      • Bhopal、印度
        • 招聘中
        • All India Institute of Medical Sciences, Bhopal
        • 接触：
        • 首席研究员：
          • Sarman Singh, MD
      • Chandigarh、印度、160012.
        • 招聘中
        • Post Graduate Institute of Medical Education and Research
        • 接触：
          • Inderpaul Singh Sehgal, DM(Pulmonary Medicine)
          • 电话号码：01722756823
          • 邮箱：inderpgi@outlook.com
        • 首席研究员：
          • Inderpaul Singh Sehgal, DM(Pulmonary Medicine)
      • Delhi、印度、110029
        • 招聘中
        • All India Institute of Medical Sciences, Delhi
        • 接触：
        • 首席研究员：
          • Anant Mohan, MD
    • Chhattisgarh
      • Raipur、Chhattisgarh、印度、492099
        • 招聘中
        • All India Institute of Medical Science, Raipur
        • 接触：
        • 首席研究员：
          • Sajal De, MD

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

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • COVID-19 positive patients with ordinal scale score of 3.
  • Patients of either gender, age ≥ 18 years at the time of enrollment.
  • Female patients 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 3 months post-dosing.
  • The patients 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:

  • Patient with ordinal scale of ≥4 at the time of hospital admission and randomization.
  • Pregnant and / or lactating female patients.
  • A family history of congenital or hereditary immunodeficiency.
  • Any disease condition requiring ICU admission.
  • History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator.
  • History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period.
  • History of allergic reactions or anaphylaxis to Mw or its component.
  • Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patient's health or is likely to result nonconformance to the protocol or a patient's ability to give written informed consent.

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：治疗
  • 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
实验性的：Suspension of Mw + Standard therapy of COVID-19
0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days + Standard therapy of COVID-19
药品：Suspension of heat killed (autoclaved) Mycobacterium w
Suspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19
安慰剂比较：Placebo
0.3 ml (0.1ml x 3 Injection) of intradermal Placebo for 3 consecutive days + Standard therapy of COVID-19
其他：Placebo
Placebo along with Standard of care (SOC) treatment for COVID-19

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 patients with increased disease severity
大体时间：From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
To compare the difference in proportion of patients with increased disease severity
From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.

次要结果测量

结果测量
措施说明
大体时间
Incidence of adverse events and serious adverse events (Safety)
大体时间：Till day 28
To evaluate safety of Mw in COVID-19 patients admitted to hospital
Till day 28
Number of COVID-19 patients discharged from hospital
大体时间：From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
To compare the proportion of patients discharged from hospital
From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
Number of COVID-19 patients transfer to ICU
大体时间：From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
To compare the proportion of patients transfer to ICU
From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
Number of COVID-19 patients with reduction in disease severity by 1 ordinal scale
大体时间：From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
To compare the proportion of patients with reduction in disease severity by 1 ordinal scale
From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
Number of of symptom free patients
大体时间：From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
To compare the proportion of symptom free patients
From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.

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。

赞助

Cadila Pharnmaceuticals

合作者

Council of Scientific and Industrial Research, India

调查人员

  • 学习椅：Sanjay Patel, 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2月28日

研究完成 (预期的)

2021年4月30日

研究注册日期

首次提交

2020年4月21日

首先提交符合 QC 标准的

2020年4月21日

首次发布 (实际的)

2020年4月24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12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CRSC20006

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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