Official Title
Treatment With Hydroxychloroquine vs Nitazoxanide + Hydroxychloroquine in Patients With COVID-19 With Risk Factors for Poor Outcome
Brief Summary

Coronaviruses (CoV) are positive-sense single-stranded RNA viruses that infect a wide range of hosts producing diseases ranging from the common cold to serious / fatal events. Nitazoxanide (NTZx) is a derivative of 5-nitrothiazole, synthesized in 1974 by Rosignol - Cavier. NTZx has 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. The purpose of this study is to contrast the beneficial effect of NTZx vs NTZx plus hydroxychloroquine in patients Coronavirus Disease (COVID-19) as well as against other treatments.

Detailed Description

Introduction The current pandemic caused by the SARS-COV2 coronavirus (COVID-19) is life-threatening and is challenging the world's best health systems. Accelerated spread of this pandemia led physicians to try a variety of treatments without a well established sequence due to ignorance about this new disease. The case fatality rate has been calculated at 2.2% but there are differences depending on the country affected.

Perspective When comparing the evolution of cases between Spain and Mexico, an apparently less pronounced trend is observed in Mexico, but this may be due to underdiagnosis. In calculations by the Mexican Ministry of Health, around 6% of the patients (approximately 10,500) who contract COVID-19 could be found serious and in need of hospitalization in intensive care.

NTZx NTZx and its circulating active metabolite, tizoxanide, inhibit the replication of a wide range of viruses, both RNA and DNA. It has action against 16 strains of Influenza A virus subtypes H1N1, H3N2, H3N2v, H3N8, H5N9, H7N1 and a strain of influenza B. It also works against respiratory syncytial virus, norovirus, dengue, yellow fever, Japanese encephalitis virus, rotavirus , hepatitis B and C, even against the human immunodeficiency virus (Severe Acute Respiratory Syndrome (SARS) and Middle East respiratory syndrome (MERS).

Problem Mexico is in Phase 2 according to the World Health Organization (WHO) and more local infections due to coronaviruses are expected. To date, various COVID-19 treatment schemes are being tested, but the usefulness of none can be assured.

When reviewing the drug schemes that are being carried out in the world, it calls the attention that developing countries are not included, beyond the fact that the tested alternatives are economically inaccessible.

This clinical survey aims to test the possible utility of NTZx against COVID-19, alone or in combination with hydroxychloroquine.

Recruiting
Coronavirus Infection

Drug: Nitazoxanide 500 MG
Clinical evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using this option with two drugs
Nitazoxanide + hydroxychloroquine
Other Name: hydroxychloroquine

Drug: Hydroxychloroquine
Clinical evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using this option with one drug
Hydroxychloroquine
Nitazoxanide + hydroxychloroquine

Eligibility Criteria

Inclusion Criteria:

- COVID-19 positive patients

- Treated at the Health Institute of the State of Mexico (ISEM).

- With risk factors to get complicated: age more than 60 years old, diabetes mellitus or obesity grade II or more.

Exclusion Criteria:

- Patients who have inherent contraindications to each drug.

Eligibility Gender
All
Eligibility Age
Minimum: 5 Years
Countries
Mexico
Contacts

Hugo Mendieta Zerón, MD, PhD.
+52-722-276-5540 90712
drmendietaz@yahoo.com

Acela Marlén Santamaría Benhumea, PhD.
+52-722-276-5540 90712
inv.maternoperinatal@gmail.com

José Meneses Calderón, MD
Principal Investigator
Hospital Materno-Perinatal "Mónica Pretelini Sáenz"

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Srivatsan Padmanabhan, MD, PhD
Principal Investigator
St. Joseph Medical Center

Hugo Mendieta Zeron
NCT Number
Keywords
treatment
Evolution
MeSH Terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Hydroxychloroquine
Nitazoxanide