Administration of Chlorpromazine as a Treatment for COVID-19
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical improvement
研究概览
简要总结
In this study, defined cases of COVID-19 confirmed with PCR, with a mild, moderate or severe pneumonia will be treated with chlorpromazine. The improvement in clinical & laboratory manifestations will be evaluated in treated patient compared to control group.
详细描述
Introduction The COVID-19 pandemic has resulted in over 6 million confirmed infected cases worldwide and over 397,000 deaths as of June 8th, 2020 according to the World Health Organization. Currently, there is no specific medication for COVID-19, as there are different protocols of treatments that is not fully tested to prove its effectiveness by randomized control trials.
Due to high infectious potentials of COVID-19, all healthcare facilities are burdened out by an extra ordinary load which is reflected on the economy of the health sector. In Addition to public health measures like self-quarantine, isolation and social distancing, coming up with proved effective treatment for Covid-19 will help markedly in restoration of normal daily activity of people. In Egypt, public health measures are not much fruitful due to lack of people awareness to properly perform self-quarantine, economic burden for performing mass nasal swabs, some other factors such as uncertainty regarding the survival of the virus in air are subsequently adding much concern to the vast quarantine task.
Hence, the focus has now been directed toward evaluating and implementing other strategies like chemoprophylaxis and vaccination. In fact, the development of vaccine will take around two years as current human trials are being employed. Thus, the hope will be shifted towards the repurposing of an actually used drug to target the viral replication cycle.
Chlorpromazine is an antagonist of the dopamine receptor D2 (DRD2) and has been effectively and safely employed for over half a century in the treatment of psychiatric disorders (Adams, Awad, Rathbone, Thornley, & Soares-Weiser, 2014). The USA Food and Drug Administration approved the chlorpromazine as a first-generation antipsychotic. It is classified as a phenothiazine as its primary use is in the management of mental disorders to control mania and treatment of schizophrenia and it has several additional approved and off-label uses. Heart conduction abnormalities related to chlorpromazine use is only related to high doses. The most commonly reported signs and symptoms of acute toxicity are severe extrapyramidal reactions, hypotension, and sedation (Beckett, 2014).
Significance of the study Globally COVID-19 has led to large numbers of infection and death. In Egypt, number of confirmed cases increased above 30,000 according to the Egyptian Ministry of Health by 8th of June 2020. Furthermore, there is a change of the treatment protocol according to the severity of signs and symptoms aiming to decrease the load on the health facilities in Egypt.
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
- Single (Participant)
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
- •Adult conscious male and female (non-pregnant, non-breast feeder), level of consciousness is assessed by Glasgow Coma Scale ≥
- •Diagnosed initially with COVID-19 confirmed with PCR prior to any interference.
- •Follow the treatment regimen for COVID-19 according to The Ministry of Health in Egypt.
- •Exclusion criteria:
- •Patients having allergy to chlorpromazine which will be assessed by asking the patient or relative.
- •Patients with hypotension(<90/60mmHg).
- •Pregnant and breast feeder female patients.
- •Hepatic patients.
- •Patients already receiving chlorpromazine.
排除标准
- 未提供
研究组 & 干预措施
Group A
The group of 50 patients are going to receive Chlorpromazine (oral dose of 50 mg/ day for 3 days then doubled to 100mg/day for further 11 days) every 24 hours for 14 days in addition to the convential treatment of COVID-19 according to the Egyptian Ministry of Health protocol.
干预措施: Chlorpromazine (Drug)
结局指标
主要结局
Clinical improvement
时间窗: 2 weeks
In the current study, the clinical improvement will be determined by: 1. Temperature 2. Heart rate (pulse) 3. Respiratory rate 4. Oxygen saturation 5. Need for oxygen 6. Hospital stay time. 7. CT lung involvement at day 0 and day 14.
次要结局
未报告次要终点
研究者
Ahmed Rezk
Clinical Instructor
Cairo University
