A Phase II B III, Multi Centre Open label Randomized Controlled trial to assess Clinical Benefits of Chlorpromazine and Standard of Care Versus Standard of Care alone in the management of moderate SARS COV 2 infection
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 176
- 试验地点
- 7
- 主要终点
- Time To Response TTR measured as the number of days since randomization in which there is reduction of at least one severity level of the disease measured using a World Health Organization 8 Point Ordinal Scale for Clinical Improvement WHO OSCI.
研究概览
简要总结
**Study Design:**Open-label, Multicentre, Randomized, Parallel-Group, Two arm study
To compare the Time to Response to treatment with Standard of Care Chlorpromazine CPZ Versus SOC alone
TTR is defined as the reduction of at least one level of severity relative to the baseline as per the World Health Organization [WHO] 8 - point ordinal scale for clinical improvement. The median time to produce the first response measured as a reduction in severity will be compared between the treatment arm SOC PLUS CPZ and the comparator
The primary measure of the efficacy of the drug chlorpromazine will be the reduction in the number of days required to produce the first response. This response is defined as the reduction in the severity of the disease
To demonstrate that greater clinical improvement is seen on treatment with SOC PLUS Chlorpromazine versus SOC alone. Clinical improvement will be monitored post-dosing and will be assessed based on the following parameters
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A decrease in the swab viral load of SARS COV 2
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A decrease in inflammatory markers will be measured at screening and End of Treatment EOT. The inflammatory markers which will be evaluated are: C Reactive Protein , lymphocytes, Interleukin-6 , Lactate dehydrogenase , inflammatory cytokines, NT-ProBNP, hScTn, Platelet count, Sr. Ferritin and coagulation factors like platelets, D-Dimer
The study population will comprise male & non-pregnant, non-lactating female patients between 18-65 years who are evaluated as moderate cases of COVID19. Moderate cases will be defined as per the ICMR guidelines and treating Investigator assessment. The selection of the participants will be strict as per the eligibility criteria described in the protocol. The recruitment will be voluntary and without any coercion. Participants will be fairly selected and no particular group will be coerced to participate. All participants will be enrolled only after obtaining valid written informed consent. In case a vulnerable population is to be enrolled, the enrolment will be properly justified so that at all times safety, wellbeing, and rights of the
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Documented COVID-19 infection as observed by positive RT-PCR for SARS-CoV-2 on the day of screening.
- •Adult having moderate form of infection defined as presence of clinical features of dyspnea, and or hypoxia, fever, cough including spO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute.
排除标准
- •Patients suffering from severe Covid-19 disease as per the physician’s discretion.
- •History of Chronic illness will be obtained and those with a history of active, ongoing disease will be excluded.
结局指标
主要结局
Time To Response TTR measured as the number of days since randomization in which there is reduction of at least one severity level of the disease measured using a World Health Organization 8 Point Ordinal Scale for Clinical Improvement WHO OSCI.
时间窗: Baseline and 3 weeks (21 days)
次要结局
- A decrease in the swab viral load of SARSCOV2(Reduction in the need for intensive care in the treatment arm versus SOC A decrease in inflammatory markers will be measured at screening and End of Treatment)