Effects of Early Use of Nitazoxanide in Patients With COVID-19

Summary

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

Population: 392 Patients with COVID-19 (Coronavirus Disease-19), confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease.

Experimental group: 196 patients, nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 196 patients, placebo 8/8 hours for 5 days.

Conditions

• Covid19
• Coronavirus

Interventions

DRUG

Nitazoxanide

Nitazoxanide 500mg 8/8 hours for 5 days in the early clinical phase of COVID-19.

DRUG

Placebo

Placebo 8/8 hours for 5 days in the early clinical phase of COVID-19.

Sponsors & Collaborators

• Ministry of Science and Technology, Brazil

  collaborator OTHER

• National Research Council, Brazil

  collaborator OTHER

• ATCGen

  collaborator UNKNOWN

• Complexo Hospitalar Municipal de São Caetano do Sul

  collaborator UNKNOWN

• Hospital de Transplante Doutor Euryclides de Jesus Zerbini

  collaborator OTHER

• Secretaria Municipal de Saúde de Bauru

  collaborator UNKNOWN

• Santa Casa de Misericórdia de Sorocaba

  collaborator UNKNOWN

• Secretaria Municipal de Saúde de Guarulhos

  collaborator UNKNOWN

• Hospital e Maternidade Therezinha de Jesus

  collaborator UNKNOWN

• Secretaria de Estado de Saúde do Distrito Federal

  collaborator UNKNOWN

• Universidade Federal do Rio de Janeiro

  lead OTHER

Principal Investigators

• 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

2020-06-08

Primary Completion

2020-08-20

Completion

2020-09-05

Countries

• Brazil

Study Locations