A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients
2021年1月25日 更新者：Cadila Pharnmaceuticals
A Clinical Trial to Evaluate the Safety and Efficacy of Mycobacterium W in Critically Ill Patients Suffering From COVID 19 Infection
The trial is randomized, blinded, two arms, active comparator controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice versus standard care alone in critically ill adult patients suffering from COVID-19 infection.
研究概览
详细说明
In this study, Eligible patients will be enrolled after due consent and will be randomized in balance to receive either test drug (along with the standard of care) or Placebo (along with the standard of care). The enrolled patients will be monitored for any adverse events (AEs) or serious adverse events (SAEs) throughout the study period. All patients will continue to receive standard therapy till considered requisite by the treating physician.
In addition to the standard care for COVID-19, patients randomized to test arm will receive single daily dose of 0.3 ml of Mw, intradermal, for 3 consecutive days while patients randomized to control arm will receive single daily dose of 0.3 ml of Placebo, intradermal, for 3 consecutive days.
Study duration for each patient will be upto 28 days post-randomization.
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
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
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Chandigarh、印度、160012
- Postgraduate Institute of Medical Education and Research
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Delhi、印度、110029
- All lndia Institute of Medical Science, Delhi
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Chhattisgarh
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Raipur、Chhattisgarh、印度、492099
- All India Institute of Medical Science, Raipur
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Madhya Pradesh
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Bhopal、Madhya Pradesh、印度、462024
- All India Institute of Medical Sciences, Bhopal
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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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Critically ill patients infected with COVID-19 (clinical/confirmed)
- Patient aged 18 years or more of either gender
Illness of any duration with respiratory rate ≥25 breaths/minute, and at least one of the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or or
- SpO2 ≤94% on room air, or
- Requiring mechanical ventilation and/or supplemental oxygen
- Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication.
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedure.
Exclusion Criteria:
- Pregnant or nursing female.
- Patients with history of allergy, hypersensitivity, or any serious reaction to study medication
- Patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk.
- Patient previously enrolled into this study.
- Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or HIV.
- Patients with a life expectancy judged to be less than five days
- ALT/AST > 5 times the upper limit of normal
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
- Patients not likely to complete the trial as per judgment of the investigator.
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 |
|---|---|
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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 |
Patients will be randomized to receive either Mycobacterium w in combination with standard care as per hospital practice or standard care alone in COVID-19 as per hospital practice.
其他名称：
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安慰剂比较：Standard therapy of COVID-19
0.3 ml (0.1ml x 3 Injection) of Placebo intra-dermal for 3 consecutive days
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All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician
其他名称：
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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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7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death)
大体时间：Change in Ordinal scale from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization.
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To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
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Change in Ordinal scale from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization.
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Sequential Organ Failure Assessment (SOFA) scores
大体时间：Change in SOFA score from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization.
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To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
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Change in SOFA score from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization.
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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 AE / SAE or event of clinical significance
大体时间：Till day 28
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Any AE / SAE or event of clinical significance observed during the study.
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Till day 28
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SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample
大体时间：At days 3, 7, 14, 21, and 28
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Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.
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At days 3, 7, 14, 21, and 28
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ICU length of stay
大体时间：Till day 28
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ICU length of stay
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Till day 28
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Duration of mechanical ventilation
大体时间：Till day 28
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Duration of mechanical ventilation
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Till day 28
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Duration of hospitalization
大体时间：Till day 28
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Duration of hospitalization
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Till day 28
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Clinical improvement
大体时间：From baseline to day 14 & Day 28
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Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale.
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From baseline to day 14 & Day 28
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Time (in days) from treatment initiation to death
大体时间：Till day 28
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Time (in days) from treatment initiation to death.
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Till day 28
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All-cause mortality
大体时间：Till day 28
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All-cause mortality
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Till day 28
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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4月30日
初级完成 (实际的)
2020年8月10日
研究完成 (实际的)
2020年8月21日
研究注册日期
首次提交
2020年3月31日
首先提交符合 QC 标准的
2020年4月11日
首次发布 (实际的)
2020年4月15日
研究记录更新
最后更新发布 (实际的)
2021年1月27日
上次提交的符合 QC 标准的更新
2021年1月25日
最后验证
2021年1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.