Trial | NCT04561219  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    500
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.
SARITA-1 is a multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms, which aims to study the impact of nitazoxanide for hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19) Experimental group: 250 patients received nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 250 patients received placebo 8/8 hours for 5 days.

Population: Patients with clinical symptoms of COVID-19: dyspnoea and/or fever and/or cough) and: either computed tomography scan suggestive of viral pneumonia or confirmatory molecular test by RT-PCR (Real Time polymerase chain reaction),
Study Started
Apr 19
2020
Primary Completion
Oct 02
2020
Study Completion
Oct 02
2020
Last Update
Jul 22
2021

Drug Nitazoxanide

Nitazoxanide 500mg three times a day for 5 days

  • Other names: annita, azox, irose, tanisea, trinida, zoxany

Drug Placebo

Placebo three times a day for 5 days

Nitazoxanide Experimental

Patients received nitazoxanide 500mg 8/8hours, for 5 days.

Placebo Placebo Comparator

Patients received placebo 500mg 8/8hours, for 5 days

Criteria 

Inclusion Criteria:

Patients requiring supplemental oxygen [peripheral oxygen saturation (SpO2) < 93%], admitted to hospital with COVID-19 symptoms associated with chest computed tomography (CT) scan suggestive of viral pneumonia or positive nasopharyngeal swab test for SARS-CoV2 (RT-PCR)
Age equal or superior to 18 years
Non-pregnant women
Willingness to receive study treatment
Providing written and informed consent or the same consent signed by a family member

Exclusion Criteria:

Impossibility to use oral medications
History of severe liver disease (Child Pugh C class)
Previous renal failure
Severe heart failure (NYHA 3 or 4)
COPD (GOLD 3 and 4)
Neoplasia in the last 5 years
Known autoimmune disease
Individuals with known hypersensitivity to study drug
Previous treatment with the study medication during the last 30 days
Clinical suspicion of tuberculosis and bacterial pneumonia
No Results Posted