Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341493
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico

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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: Nitazoxanide 500 MG Drug: Hydroxychloroquine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this study all patients with a COVID-19 positive result attended at the Health Institute of the State of Mexico (ISEM), will be invited to participate and offered one of two options that try to reduce the complications of this disease.
Masking: Single (Participant)
Masking Description: Patients won´t know whether the treatment they receive is hydroxychloroquine or nitazoxanide + hydroxychloroquine.
Primary Purpose: Treatment
Official Title: Treatment With Hydroxychloroquine vs Nitazoxanide + Hydroxychloroquine in Patients With COVID-19 With Risk Factors for Poor Outcome
Actual Study Start Date : April 6, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : December 30, 2020


Arm Intervention/treatment
Experimental: Nitazoxanide + hydroxychloroquine
Hydroxychloroquine 400 mg PO every 12 hours for two days and then 200 mg PO every 12 hours for four days + Nitazoxanide 500 mg PO every 6 hours for six days
Drug: Nitazoxanide 500 MG
Clinical evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using this option with two drugs
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

Active Comparator: Hydroxychloroquine
Hydroxychloroquine 200 mg PO every 12 hours for 7 days
Drug: Hydroxychloroquine
Clinical evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using this option with one drug




Primary Outcome Measures :
  1. Mechanical ventilation requirement [ Time Frame: Since the diagnosis until two weeks after ]
    Percentage of patients COVID-19 positive that required mechanical ventilation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT04341493


Contacts
Layout table for location contacts
Contact: Hugo Mendieta Zerón, MD, PhD. +52-722-276-5540 ext 90712 drmendietaz@yahoo.com
Contact: Acela Marlén Santamaría Benhumea, PhD. +52-722-276-5540 ext 90712 inv.maternoperinatal@gmail.com

Locations
Layout table for location information
Mexico
Materno-Perinatal Hospital "Mónica Pretelini" Recruiting
Toluca, Mexico, 50130
Principal Investigator: Hugo Mendieta Zeron, PhD         
Sponsors and Collaborators
Hugo Mendieta Zeron
Investigators
Layout table for investigator information
Principal Investigator: José Meneses Calderón, MD Hospital Materno-Perinatal "Mónica Pretelini Sáenz"
Principal Investigator: Srivatsan Padmanabhan, MD, PhD St. Joseph Medical Center
Publications:
Layout table for additonal information
Responsible Party: Hugo Mendieta Zeron, Chief of the Research Department, Materno-Perinatal Hospital of the State of Mexico
ClinicalTrials.gov Identifier: NCT04341493    
Other Study ID Numbers: 2020-03-681
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: If the final selected medical journal to send the paper of our research request it, we will add the full database of the studied population.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: After finishing the study.
Access Criteria: Requested by the journal or after publication if any researcher in the world express interest if the information of this survey.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico:
Treatment
Evolution
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hydroxychloroquine
Nitazoxanide
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents