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临床试验/NCT04341493
NCT04341493终止4 期

Treatment With Hydroxychloroquine vs Nitazoxanide + Hydroxychloroquine in Patients With COVID-19 With Risk Factors for Poor Outcome

Hugo Mendieta Zeron1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年4月6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
终止
发起方
入组人数
44
试验地点
1
主要终点
Mechanical ventilation requirement

研究概览

简要总结

Coronaviruses (CoV) are positive-sense single-stranded RNA viruses that infect a wide range of hosts producing diseases ranging from the common cold to serious / fatal events. Nitazoxanide (NTZx) is a derivative of 5-nitrothiazole, synthesized in 1974 by Rosignol - Cavier. NTZx has 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. The purpose of this study is to contrast the beneficial effect of NTZx vs NTZx plus hydroxychloroquine in patients Coronavirus Disease (COVID-19) as well as against other treatments.

详细描述

Introduction The current pandemic caused by the SARS-COV2 coronavirus (COVID-19) is life-threatening and is challenging the world's best health systems. Accelerated spread of this pandemia led physicians to try a variety of treatments without a well established sequence due to ignorance about this new disease. The case fatality rate has been calculated at 2.2% but there are differences depending on the country affected.

Perspective When comparing the evolution of cases between Spain and Mexico, an apparently less pronounced trend is observed in Mexico, but this may be due to underdiagnosis. In calculations by the Mexican Ministry of Health, around 6% of the patients (approximately 10,500) who contract COVID-19 could be found serious and in need of hospitalization in intensive care.

NTZx NTZx and its circulating active metabolite, tizoxanide, inhibit the replication of a wide range of viruses, both RNA and DNA. It has action against 16 strains of Influenza A virus subtypes H1N1, H3N2, H3N2v, H3N8, H5N9, H7N1 and a strain of influenza B. It also works against respiratory syncytial virus, norovirus, dengue, yellow fever, Japanese encephalitis virus, rotavirus , hepatitis B and C, even against the human immunodeficiency virus (Severe Acute Respiratory Syndrome (SARS) and Middle East respiratory syndrome (MERS).

Problem Mexico is in Phase 2 according to the World Health Organization (WHO) and more local infections due to coronaviruses are expected. To date, various COVID-19 treatment schemes are being tested, but the usefulness of none can be assured.

When reviewing the drug schemes that are being carried out in the world, it calls the attention that developing countries are not included, beyond the fact that the tested alternatives are economically inaccessible.

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)

盲法说明

Patients won´t know whether the treatment they receive is hydroxychloroquine or nitazoxanide + hydroxychloroquine.

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COVID-19 positive patients
  • Treated at the Health Institute of the State of Mexico (ISEM).
  • With risk factors to get complicated: age more than 60 years old, diabetes mellitus or obesity grade II or more.

排除标准

  • Patients who have inherent contraindications to each drug.

研究组 & 干预措施

Nitazoxanide + hydroxychloroquine

Experimental

Hydroxychloroquine 400 mg PO every 12 hours for two days and then 200 mg PO every 12 hours for four days + Nitazoxanide 500 mg PO every 6 hours for six days

干预措施: Nitazoxanide 500 MG (Drug)

Nitazoxanide + hydroxychloroquine

Experimental

Hydroxychloroquine 400 mg PO every 12 hours for two days and then 200 mg PO every 12 hours for four days + Nitazoxanide 500 mg PO every 6 hours for six days

干预措施: Hydroxychloroquine (Drug)

Hydroxychloroquine

Active Comparator

Hydroxychloroquine 200 mg PO every 12 hours for 7 days

干预措施: Hydroxychloroquine (Drug)

结局指标

主要结局

Mechanical ventilation requirement

时间窗: Since the diagnosis until two weeks after

Percentage of patients COVID-19 positive that required mechanical ventilation

次要结局

未报告次要终点

研究者

发起方
Hugo Mendieta Zeron
申办方类型
Other
责任方
Sponsor 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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