Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19

Coronavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04341493
• Other study ID #: 2020-03-681
• Status: Terminated
• Phase: Phase 4
• Start date: April 6, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2021
• Source: Materno-Perinatal Hospital of the State of Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: December 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Nitazoxanide 500 MG
Clinical evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using this option with two drugs
• Hydroxychloroquine
Clinical evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using this option with one drug

Locations

Country	Name	City	State
Mexico	Materno-Perinatal Hospital "Mónica Pretelini"	Toluca

Sponsors (1)

Lead Sponsor	Collaborator
Hugo Mendieta Zeron

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Li H, Wang YM, Xu JY, Cao B. [Potential antiviral therapeutics for 2019 Novel Coronavirus]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Mar 12;43(3):170-172. doi: 10.3760/cma.j.issn.1001-0939.2020.03.004. Chinese. — View Citation

Mo Y, Fisher D. A review of treatment modalities for Middle East Respiratory Syndrome. J Antimicrob Chemother. 2016 Dec;71(12):3340-3350. Epub 2016 Sep 1. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical ventilation requirement	Percentage of patients COVID-19 positive that required mechanical ventilation	Since the diagnosis until two weeks after