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

Primary Purpose

Coronavirus Infection

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Nitazoxanide 500Mg Oral Tablet
Sponsored by
Materno-Perinatal Hospital of the State of Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring evolution, nitazoxanide

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COVID-19 positive patients by clinical criteria.

Exclusion Criteria:

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

Sites / Locations

  • Materno-Perinatal Hospital "Mónica Pretelini"

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nitazoxanide early treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 24, 2020
Last Updated
March 29, 2021
Sponsor
Materno-Perinatal Hospital of the State of Mexico
Collaborators
Laboratorios Liomont
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1. Study Identification

Unique Protocol Identification Number
NCT04406246
Brief Title
Prevention of Coronavirus Disease (COVID-19) Outbreaks With Nitazoxanide
Official Title
Prevention of Coronavirus Disease (COVID-19) Outbreaks by Prophylactic Treatment With Nitazoxanide
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Materno-Perinatal Hospital of the State of Mexico
Collaborators
Laboratorios Liomont

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection
Keywords
evolution, nitazoxanide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitazoxanide early treatment
Arm Type
Experimental
Arm Description
Health workers with symptoms of COVID-19 not requiring hospitalization will receive an early treatment with nitazoxanide.
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide 500Mg Oral Tablet
Other Intervention Name(s)
Paramix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health workers that require hospitalization
Description
The percentage of health workers that require hospitalization after beginning an early treatment with nitazoxanide in case of referring symptoms of COVID-19.
Time Frame
Two weeks since the begining of symptoms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Meneses Calderón, MD.
Organizational Affiliation
Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Materno-Perinatal Hospital "Mónica Pretelini"
City
Toluca
ZIP/Postal Code
50130
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The Data will be available upon request after a publication is reached.
Citations:
PubMed Identifier
32186952
Citation
Dhama K, Sharun K, Tiwari R, Dadar M, Malik YS, Singh KP, Chaicumpa W. COVID-19, an emerging coronavirus infection: advances and prospects in designing and developing vaccines, immunotherapeutics, and therapeutics. Hum Vaccin Immunother. 2020 Jun 2;16(6):1232-1238. doi: 10.1080/21645515.2020.1735227. Epub 2020 Mar 18.
Results Reference
background
PubMed Identifier
32088248
Citation
Mifsud EJ, Tilmanis D, Oh DY, Ming-Kay Tai C, Rossignol JF, Hurt AC. Prophylaxis of ferrets with nitazoxanide and oseltamivir combinations is more effective at reducing the impact of influenza a virus infection compared to oseltamivir monotherapy. Antiviral Res. 2020 Apr;176:104751. doi: 10.1016/j.antiviral.2020.104751. Epub 2020 Feb 20.
Results Reference
background
PubMed Identifier
27095301
Citation
Rossignol JF. Nitazoxanide, a new drug candidate for the treatment of Middle East respiratory syndrome coronavirus. J Infect Public Health. 2016 May-Jun;9(3):227-30. doi: 10.1016/j.jiph.2016.04.001. Epub 2016 Apr 16.
Results Reference
background
PubMed Identifier
25108173
Citation
Rossignol JF. Nitazoxanide: a first-in-class broad-spectrum antiviral agent. Antiviral Res. 2014 Oct;110:94-103. doi: 10.1016/j.antiviral.2014.07.014. Epub 2014 Aug 7.
Results Reference
background

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

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