Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19

NCT04341493 | Terminated Phase 4

• 1 other identifier: 2020-03-681
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection

Keywords

Treatment; Evolution

Outcome Measures

Primary Outcomes (1)

• Mechanical ventilation requirement

  Percentage of patients COVID-19 positive that required mechanical ventilation

  Since the diagnosis until two weeks after

Study Arms (2)

Nitazoxanide + hydroxychloroquine

EXPERIMENTAL

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; Drug: Hydroxychloroquine

Hydroxychloroquine

ACTIVE COMPARATOR

Hydroxychloroquine 200 mg PO every 12 hours for 7 days

Drug: Hydroxychloroquine

Interventions

Nitazoxanide 500 MG DRUG

Clinical evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using this option with two drugs

Also known as: hydroxychloroquine

Nitazoxanide + hydroxychloroquine

Hydroxychloroquine DRUG

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

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who have inherent contraindications to each drug.

Sponsors & Collaborators

• Hugo Mendieta Zeron: lead

Study Sites (1)

Materno-Perinatal Hospital "Mónica Pretelini"

Toluca, 50130, Mexico

Location

Related Publications (4)

• 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

• Mo Y, Fisher D. A review of treatment modalities for Middle East Respiratory Syndrome. J Antimicrob Chemother. 2016 Dec;71(12):3340-3350. doi: 10.1093/jac/dkw338. Epub 2016 Sep 1.

  PMID: 27585965 BACKGROUND

• 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.

  PMID: 32164080 BACKGROUND

• Calderon JM, Zeron HM, Padmanabhan S. Treatment with Hydroxychloroquine vs Hydroxychloroquine + Nitazoxanide in COVID-19 patients with risk factors for poor prognosis: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 8;21(1):504. doi: 10.1186/s13063-020-04448-2.

  PMID: 32513231 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

nitazoxanide; Hydroxychloroquine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• José Meneses Calderón, MD

  Hospital Materno-Perinatal "Mónica Pretelini Sáenz"

  PRINCIPAL INVESTIGATOR

• Srivatsan Padmanabhan, MD, PhD

  St. Joseph Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients won´t know whether the treatment they receive is hydroxychloroquine or nitazoxanide + hydroxychloroquine.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of the Research Department

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: April 6, 2020
• Primary Completion: August 30, 2020
• Study Completion: December 30, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

ME (1)