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
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- 1. To evaluate the efficacy of Mw by measuring the improvement in Ordinal scale.
研究概览
简要总结
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 water for injection, 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
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Critically ill COVID-19 patients who have been tested positive by RT-PCR for SARS-CoV-2 on the nasopharyngeal or throat swabs.
- •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:.
- •SpO2 ≤90% 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, leukemia 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.
结局指标
主要结局
1. To evaluate the efficacy of Mw by measuring the improvement in Ordinal scale.
时间窗: 1. From baseline to day 3, 7, 14, 21 and 28 and day of transfer from ICU, if earlier than 28 days. | 2.Till day 28, post-randomization or death or discharge, whichever is earlier.
2. To evaluate 28-day mortality.
时间窗: 1. From baseline to day 3, 7, 14, 21 and 28 and day of transfer from ICU, if earlier than 28 days. | 2.Till day 28, post-randomization or death or discharge, whichever is earlier.
次要结局
- To evaluate Change in Sequential Organ Failure Assessment (SOFA) score(Baseline to day 3, 7, 14, 21 and 28 and day of transfer from ICU, if earlier than 28 days post-randomization.)
- To evaluate the safety/tolerability by determining the incidence of adverse events in the Mw(Any AE / SAE or event of clinical significance observed during the study.)