Prevention of Coronavirus Disease (COVID-19) Outbreaks With Nitazoxanide
Condition: Coronavirus Infection
MeSH terms: Coronavirus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Nitazoxanide 500Mg Oral Tablet
Intervention type(s): Drug
Intervention description(s): Health workers affected by SARS-CoV-2 will receive the next doses of nitazoxanide: 500 mg every 6 hour for two days and then every 12 hours for four days.
Other intervention name(s): Paramix
Intervention MeSH terms: Nitazoxanide
Intervention model: Single Group Assignment
Intervention model description: In this cohort study, all health workers of the Maternal-Perinatal Hospital "Mónica Pretelini Sáenz", with symptoms of SARS-CoV-2 will be treated promptly with nitazoxanide.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: evolution; nitazoxanide