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

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ClinicalTrials.gov Identifier: NCT04406246
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
Laboratorios Liomont
Information provided by (Responsible Party):
Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico

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.


Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: Nitazoxanide 500Mg Oral Tablet Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
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
Official Title: Prevention of Coronavirus Disease (COVID-19) Outbreaks by Prophylactic Treatment With Nitazoxanide
Actual Study Start Date : May 21, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nitazoxanide early treatment
Health workers with symptoms of COVID-19 not requiring hospitalization will receive an early treatment with nitazoxanide.
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




Primary Outcome Measures :
  1. Health workers that require hospitalization [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COVID-19 positive patients by clinical criteria.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406246


Contacts
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Contact: Hugo Mendieta Zerón, MD., PhD. +52-722-276-5540 inv.maternoperinatal@gmail.com
Contact: Marlen Santamaría Benhumea, PhD. +52-722-276-5540 marlen_benhumea04@hotmail.com

Locations
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Mexico
Materno-Perinatal Hospital "Mónica Pretelini" Recruiting
Toluca, Mexico, 50130
Contact: Nancy Santamaría Benhumea, Bachelor in Law    +52-722-276-5540    nysbeth@hotmail.com   
Principal Investigator: Hugo Mendieta Zeron, PhD         
Principal Investigator: José Meneses Calderón, MD         
Sponsors and Collaborators
Materno-Perinatal Hospital of the State of Mexico
Laboratorios Liomont
Investigators
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Principal Investigator: José Meneses Calderón, MD. Research Unit
Publications:
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Responsible Party: Hugo Mendieta Zeron, Chief of the Research Department, Materno-Perinatal Hospital of the State of Mexico
ClinicalTrials.gov Identifier: NCT04406246    
Other Study ID Numbers: 2020-04-682
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The Data will be available upon request after a publication is reached.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico:
evolution
nitazoxanide
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents