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临床试验/NCT04406246
NCT04406246已完成4 期

Prevention of Coronavirus Disease (COVID-19) Outbreaks by Prophylactic Treatment With Nitazoxanide

Materno-Perinatal Hospital of the State of Mexico1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年5月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Health workers that require hospitalization

研究概览

简要总结

The new coronavirus outbreak has led to a public health emergency of international concern, putting all health organizations on high alert. As part of the hygienic measures, isolation and reinforcement cleaning strategies have been followed. It is known that special attention and efforts should be applied to protect or reduce transmission in susceptible populations, including the elderly or those with comorbidities.It has also been proposed a semaforization to classify patients with respiratory symptoms based on: Fever (38ºC or more), dry cough, headache, dyspnea, joint pain, muscle pain, sore throat, nose discharge, conjunctivitis, chest pain, diarrhea, anosmia, ageusia.

Nitazoxanide has shown to be effective against several viruses, of both types RNA and DNA, including other coronavirus that produced the Severe Acute Respiratory Syndrome (SARS) and the Middle East Respiratory Syndrome (MERS).

Facing the lack of options against COVID-19 outbreaks for example in health workers, nitazoxanide could contribute to decrease the contagious dissemination of SARS-CoV-2, thus reducing at the same time the Hospital saturation of patients positive to this virus.

详细描述

Coronaviruses (CoV) are positive-stranded single-stranded RNA viruses that infect a wide range of hosts. The new coronavirus outbreak has led to a public health emergency of international concern, putting all health organizations on high alert.

The accelerated spread pushed physicians to try a variety of treatments without an established sequence due to ignorance of the disease. As part of the hygienic measures, isolation and reinforcement cleaning strategies have been followed. With current epidemiological data, it is known that special attention and efforts should be applied to reduce the transmission in susceptible populations, including the elderly or those with comorbidities. On the other hand it has also been proposed a semaforization to classify the severity of COVID-19 cases.

Nitazoxanide, a drug with antibacterial and anti-protozoal effects, has also powerful antiviral effects through the phosphorylation of protein-kinase activated by double-stranded RNA, which leads to an increase in phosphorylated factor 2-alpha, an intracellular protein with antiviral effects. This drug has been effective in vitro against Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome by Coronavirus (MERS), both produced by other coronavirus.

Currently all the efforts in the world have been focused on the treatment of COVID-19 since there is pneumonia, the patient being in hospitalization and even in intensive care units. Probably, focusing on these late stages has distracted the attention of the initial stage, this means early treatment to prevent the evolution to critical clinical conditions.

It is hypothesized that the use of nitazoxanide at an early stage of COVID-19 could decrease the contagious outbreaks of this virus in health workers, and at the same time will reduce the community dissemination and evolution of cases requiring intensive care units.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COVID-19 positive patients by clinical criteria.

排除标准

  • Patients who have inherent contraindications to nitazoxanide.
  • Patients with inflammatory bowel disease.

研究组 & 干预措施

Nitazoxanide early treatment

Experimental

Health workers with symptoms of COVID-19 not requiring hospitalization will receive an early treatment with nitazoxanide.

干预措施: Nitazoxanide 500Mg Oral Tablet (Drug)

结局指标

主要结局

Health workers that require hospitalization

时间窗: Two weeks since the begining of symptoms

The percentage of health workers that require hospitalization after beginning an early treatment with nitazoxanide in case of referring symptoms of COVID-19.

次要结局

未报告次要终点

研究者

发起方
Materno-Perinatal Hospital of the State of Mexico
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hugo Mendieta Zeron

Chief of the Research Department

Materno-Perinatal Hospital of the State of Mexico

研究点 (1)

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