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

NCT04406246 | Completed Phase 4 DMC

• 1 other identifier: 2020-04-682
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection

Keywords

evolution; nitazoxanide

Outcome Measures

Primary Outcomes (1)

• 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.

  Two weeks since the begining of symptoms

Study Arms (1)

Nitazoxanide early treatment

EXPERIMENTAL

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

Drug: Nitazoxanide 500Mg Oral Tablet

Interventions

Nitazoxanide 500Mg Oral Tablet DRUG

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.

Also known as: Paramix

Nitazoxanide early treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COVID-19 positive patients by clinical criteria.

You may not qualify if:

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

Sponsors & Collaborators

• Materno-Perinatal Hospital of the State of Mexico: lead
• Laboratorios Liomont: collaborator

Study Sites (1)

Materno-Perinatal Hospital "Mónica Pretelini"

Toluca, 50130, Mexico

Location

Related Publications (4)

• 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.

  PMID: 32186952 BACKGROUND

• 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.

  PMID: 32088248 BACKGROUND

• 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.

  PMID: 27095301 BACKGROUND

• 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.

  PMID: 25108173 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections

Interventions

nitazoxanide; Tablets

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• José Meneses Calderón, MD.

  Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Research Department

Model Details: 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.

Study Record Dates

• First Submitted: May 24, 2020
• First Posted: May 28, 2020
• Study Start: May 21, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

ME (1)