Official Title
Prevention of Coronavirus Disease (COVID-19) Outbreaks by Prophylactic Treatment With Nitazoxanide
Brief 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.

Completed
Coronavirus Infection

Drug: Nitazoxanide 500Mg Oral Tablet

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 Name: Paramix

Eligibility Criteria

Inclusion Criteria:

- COVID-19 positive patients by clinical criteria.

Exclusion Criteria:

- Patients who have inherent contraindications to nitazoxanide.

- Patients with inflammatory bowel disease.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Mexico
Locations

Materno-Perinatal Hospital "Mónica Pretelini"
Toluca, Mexico

José Meneses Calderón, MD., Principal Investigator
Research Unit

Laboratorios Liomont
NCT Number
Keywords
Evolution
Nitazoxanide
MeSH Terms
Coronavirus Infections
Nitazoxanide