A Clinical Trial to Evaluate the Safety and Efficacy of Mycobacterium W in Critically Ill Patients Suffering From COVID 19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigator, patient and study staff will be blinded to the study treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Suspension of heat killed (autoclaved) Mycobacterium w (Drug)
Standard therapy of COVID-19
0.3 ml (0.1ml x 3 Injection) of Placebo intra-dermal for 3 consecutive days
干预措施: Placebo (Drug)
结局指标
主要结局
7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death)
时间窗: 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.
To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Sequential Organ Failure Assessment (SOFA) scores
时间窗: 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.
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
次要结局
- ICU length of stay(Till day 28)
- Duration of mechanical ventilation(Till day 28)
- Incidence of AE / SAE or event of clinical significance(Till day 28)
- SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample(At days 3, 7, 14, 21, and 28)
- Duration of hospitalization(Till day 28)
- Time (in days) from treatment initiation to death(Till day 28)
- Clinical improvement(From baseline to day 14 & Day 28)
- All-cause mortality(Till day 28)