CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 500 enrolled
Drug / intervention
Nitazoxanide +1 moredrug
Likely dose
Nitazoxanide 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04561219
NCT04561219Phase 2Completed
CompareCT.gov

Nitazoxanide for Moderate to Severe COVID-19 Pneumonia: a Multicenter, Randomized, Placebo-controlled, Double-Blind Clinical Trial

Universidade Federal do Rio de Janeiro·interventional·Posted Sep 23, 2020·Updated Jul 22, 2021

In Brief

A Phase 2 clinical trial evaluating Nitazoxanide and Placebo for Covid19 and 2 related conditions. Completed, enrolled 500 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19, Corona Virus Infection, Pneumonia, Viral
CountriesBrazil
CollaboratorsMinistry of Science and Technology, Brazil, National Research Council, Brazil, Financiadora de Estudos e Projetos, ATCGen, Hospital Central da Aeronáutica, Rio de Janeiro, Hospital da Força Aérea do Galeão, Hospital Naval Marcilio Dias, Hospital Universitario Pedro Ernesto, Hospital de Força Aérea de São Paulo, Hospital das Clínicas Luzia de Pinho Melo, Complexo Hospitalar Municipal de São Caetano do Sul, Hospital Municipal de Barueri Dr Francisco Moran, Hospital Regional de Sorocaba Dr Adib Domingos Jatene, Hospital Geral de São Mateus Dr Manoel Bifulco, Santa Casa de Misericórdia de Belo Horizonte, Mater Dei Hospital, Brazil, Hospital Eduardo de Menezes, Hospital das Clínicas da Universidade Federal de Pernambuco, Hospital das Forças Armadas, Brazil, Hospital Regional da Asa Norte, Brazil, Complexo Hospitalar do Trabalhador de Curitiba, Hospital Estadual de Doenças Tropicais Dr Anuar Auad, Hospital Geral de Fortaleza

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 23, 2020
Enrollment StartApr 19, 2020
Primary CompletionOct 2, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.8 years ago

Interventions

Nitazoxanidedrug

Nitazoxanide 500mg three times a day for 5 days

Placebodrug

Placebo three times a day for 5 days