Prevention of Coronavirus Disease (COVID-19) Outbreaks With Nitazoxanide
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| ClinicalTrials.gov Identifier: NCT04406246 |
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Recruitment Status :
Recruiting
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
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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 |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Nitazoxanide early treatment
Health workers with symptoms of COVID-19 not requiring hospitalization will receive an early treatment with nitazoxanide.
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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 |
- 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.
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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 |
Inclusion Criteria:
- COVID-19 positive patients by clinical criteria.
Exclusion Criteria:
- Patients who have inherent contraindications to nitazoxanide.
- Patients with inflammatory bowel disease.
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
| 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 |
| 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 | |
| Principal Investigator: | José Meneses Calderón, MD. | Research Unit |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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evolution nitazoxanide |
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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 |