Nitazoxanide Therapy for Patients With COVID-19 Pneumonia

Summary

Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms.

Population: 500 Hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19), either confirmed by RT-PCR (Real Time polymerase chain reaction), or suggested by typical findings on the computed tomography scan symptomatic.

Experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: placebo 8/8 hours for 5 days.

Conditions

• Covid19
• Corona Virus Infection
• Pneumonia, Viral

Interventions

DRUG

Nitazoxanide

Nitazoxanide 500mg three times a day for 5 days

DRUG

Placebo

Placebo three times a day for 5 days

Sponsors & Collaborators

• Ministry of Science and Technology, Brazil

  collaborator OTHER

• National Research Council, Brazil

  collaborator OTHER

• Financiadora de Estudos e Projetos

  collaborator OTHER

• ATCGen

  collaborator UNKNOWN

• Hospital Central da Aeronáutica, Rio de Janeiro

  collaborator UNKNOWN

• Hospital da Força Aérea do Galeão

  collaborator UNKNOWN

• Hospital Naval Marcilio Dias

  collaborator UNKNOWN

• Hospital Universitario Pedro Ernesto

  collaborator OTHER

• Hospital de Força Aérea de São Paulo

  collaborator UNKNOWN

• Hospital das Clínicas Luzia de Pinho Melo

  collaborator UNKNOWN

• Complexo Hospitalar Municipal de São Caetano do Sul

  collaborator UNKNOWN

• Hospital Municipal de Barueri Dr Francisco Moran

  collaborator UNKNOWN

• Hospital Regional de Sorocaba Dr Adib Domingos Jatene

  collaborator UNKNOWN

• Hospital Geral de São Mateus Dr Manoel Bifulco

  collaborator UNKNOWN

• Santa Casa de Misericórdia de Belo Horizonte

  collaborator OTHER

• Mater Dei Hospital, Brazil

  collaborator OTHER

• Hospital Eduardo de Menezes

  collaborator UNKNOWN

• Hospital das Clínicas da Universidade Federal de Pernambuco

  collaborator UNKNOWN

• Hospital das Forças Armadas, Brazil

  collaborator OTHER

• Hospital Regional da Asa Norte, Brazil

  collaborator UNKNOWN

• Complexo Hospitalar do Trabalhador de Curitiba

  collaborator UNKNOWN

• Hospital Estadual de Doenças Tropicais Dr Anuar Auad

  collaborator UNKNOWN

• Hospital Geral de Fortaleza

  collaborator OTHER_GOV

• Universidade Federal do Rio de Janeiro

  lead OTHER

Principal Investigators

• Pedro L Silva, PhD · Universidade Federal do Rio de Janeiro

• Patricia RM Rocco, MD, PhD · Universidade Federal do Rio de Janeiro

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-19

Primary Completion

2020-10-02

Completion

2020-10-02

Countries

• Brazil

Study Locations