CTRI/2021/10/037502尚未招募不适用
A randomized, placebo controlled, double-blind study to evaluate the safety and efficacy of oral Ambroxol in hospitalized patients with COVID-19
ICMR1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of patients showing clinical improvement: Clinical improvement is defined as the patients meeting the discharge criteria or a 2-point improvement in the disease severity on the 8-point ordinal scale. Discharge criteria includes resolution of clinical symptoms, biochemical tests or radiological improvement, as per discretion of the Investigator.
研究概览
简要总结
| This randomized, placebo controlled, double blind study comparing safety and efficacy of Ambroxol with current standard of care versus Placebo and standard of care in hospitalized patients with moderate COVID-19 will be conducted for a duration of 6 months at the Department of Clinical Pharmacology in collaboration with Department of Medicine, Seth GSMC and KEMH, Mumbai only after Ethics Committee approval. Patients who are diagnosed to have COVID -19 per RT PCR and admitted with moderate COVID-19. Based on eligibility criteria, they will be screened, counselled and enrolled in the study. A total of 60 patients (30 in Ambroxol group and 30 in Placebo group) will be recruited. They will be randomized by Sequentially Numbered Opaque Sealed Envelope (SNOSE) technique with an allocation of 1:1 maintained for both groups. A pre-designed case record from will be used to capture all the relevant parameters during the study. Chest X ray will be performed at the baseline and again before the discharge. In Group A: 30 patients will be given Tablet Ambroxol 60 mg orally TDS till discharge or for 14 days whichever is earlier along with SOC. In Group B: 30 patients will be given matching placebo tablets + SOC till discharge or for 14 days whichever is earlier. They will be evaluated for proportion of patients showing clinical improvement, time to clinical improvement and overall survival of patients. A Clinical Improvement Scale [ordinal 8-point scale ( Ranging from ambulatory to death and acknowledges the severity of illness over time] will be administered at baseline, day 1, day 3, day 5, day 7 and day 10 or at discharge, whichever is earlier. In case the patient is admitted beyond day 10, the scale will be administered till day 10 as per the above-mentioned schedule and again at discharge. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants who are able to provide a written informed consent or have a legally accepted representative to provide the same.
- •Participants who are between 18 years and 75 years of age.
- •Participants who are proven to be positive for SARS-CoV-2 infection, as confirmed by the RT-PCR test.
- •Participants who are admitted with moderate COVID-19 for treatment at the hospital.
- •Female participants with a negative urine pregnancy test at screening.
- •Participants who are able to take the study drug orally and comply with the study procedures.
排除标准
- •Participants who are participating in any other clinical trial or experimental treatment for COVID-
- •Participants with pre-existing respiratory illness.
- •Participants with persistent vomiting (more than three episodes of vomiting in 12 hours) and who cannot tolerate oral drugs.
- •Participants requiring concomitant use of invasive or non-invasive mechanical ventilation.
- •Participants requiring vasopressors or ionotropic medications.
- •Female Participants who are lactating.
- •Participants who are known to be HIV positive or positive for Hepatitis B or C.
- •(The same may be noted based on history given by the subject or standards of care followed at the individual sites.) Participants who are not deemed fit as per the investigator or his/her team for any other medical reason.
- •Past history of allergy to Ambroxol.
结局指标
主要结局
Proportion of patients showing clinical improvement: Clinical improvement is defined as the patients meeting the discharge criteria or a 2-point improvement in the disease severity on the 8-point ordinal scale. Discharge criteria includes resolution of clinical symptoms, biochemical tests or radiological improvement, as per discretion of the Investigator.
时间窗: Timepoints: Baseline, day 1, day 3, day 5, day 7 and day 10 or at discharge, whichever is earlier. | (In case the patient is admitted beyond day 10, the scale will be administered till day 10 as per the above-mentioned schedule and again at discharge.)
次要结局
- Overall survival of the subjects: [Time Frame: 14 days]: 14-Day Overall Survival is defined as the status of the subject at the end of 14 days, beginning from the time of study in both the treatment groups.(Proportion of patients with progression of COVID-19 associated pneumonitis)
研究者
研究点 (1)
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