Nitazoxanide Therapy for Patients With COVID-19 Pneumonia
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ClinicalTrials.gov Identifier: NCT04561219 |
Recruitment Status :
Completed
First Posted : September 23, 2020
Last Update Posted : July 22, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 Corona Virus Infection Pneumonia, Viral | Drug: Nitazoxanide Drug: Placebo | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Hospitalized patients with clinical signs of COVID-19, and either chest tomography scans suggestive of COVID-19 or confirmed by RT-PCR molecular tests, will be randomly divided into 2 groups: experimental and control groups. Experimental group: 250 hospitalized patients diagnosed with COVID-19 derived pneumonia will receive nitazoxanide 500mg 8/8 hs for 5 days. Control group: 250 hospitalized patients diagnosed with COVID-19 derived pneumonia will receive placebo 8/8 hs for 5 days. |
Masking: | Double (Participant, Care Provider) |
Masking Description: | Patients were randomly allocated into one of the two groups: A or B. Patients received labelled medication: A or B, by the pharmacist. Patients received an identification number, so care providers, outcomes assessors and investigators did not know anything regarding the patients' groups. |
Primary Purpose: | Treatment |
Official Title: | Nitazoxanide for Moderate to Severe COVID-19 Pneumonia: a Multicenter, Randomized, Placebo-controlled, Double-Blind Clinical Trial |
Actual Study Start Date : | April 19, 2020 |
Actual Primary Completion Date : | October 2, 2020 |
Actual Study Completion Date : | October 2, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Nitazoxanide
Patients received nitazoxanide 500mg 8/8hours, for 5 days.
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Drug: Nitazoxanide
Nitazoxanide 500mg three times a day for 5 days
Other Names:
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Placebo Comparator: Placebo
Patients received placebo 500mg 8/8hours, for 5 days
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Drug: Placebo
Placebo three times a day for 5 days |
- Orotracheal intubation rate [ Time Frame: 14 days ]Compare the intubation rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 14 days; verified by clinical evolution; quantified by percentage.
- Hospitalisation days [ Time Frame: 14 days ]Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed at the hospital, in the period of 14 days; verified by clinical evolution; quantified by absolute number.
- ICU days [ Time Frame: 14 days ]Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed at the ICU, in the period of 14 days; verified by clinical evolution; quantified by absolute number.
- Intranasal oxygen support days [ Time Frame: 14 days ]Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed with the support of oxygen nasal cannula, in the period of 14 days; verified by clinical evolution; quantified by absolute number.
- Mortality rate [ Time Frame: 14 days ]Compare the mortality rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 14 days; verified by clinical evolution; quantified by absolute number.
- Days with fever [ Time Frame: 14 days ]Reduction in the duration of fever of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.
- Days with cough [ Time Frame: 14 days ]Reduction in the duration of cough of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.
- Days with dyspnea [ Time Frame: 14 days ]Reduction in the duration of dyspnea of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.
- Radiologic findings [ Time Frame: Day1 ]Compare chest tomographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of radiologic data; quantified by the number of patients that presented the a list of alterations.
- Radiologic findings [ Time Frame: Day7 ]Compare chest tomographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of radiologic data; quantified by the number of patients that presented the a list of alterations.
- Cardiologic findings [ Time Frame: Day1 ]Compare echocardiographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of echocardiographic data; quantified by the number of patients that presented the a list of alterations.
- Cardiologic findings [ Time Frame: Day7 ]Compare echocardiographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of echocardiographic data; quantified by the number of patients that presented the a list of alterations.
- C-reactive protein - absolute number [ Time Frame: Day 1 ]To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
- C-reactive protein serum levels [ Time Frame: Day 3 ]To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
- C-reactive protein serum levels [ Time Frame: Day 7 ]To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
- Lactate dehydrogenase (LDH) serum levels [ Time Frame: Day 1 ]To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
- Lactate dehydrogenase (LDH) serum levels [ Time Frame: Day 3 ]To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
- Lactate dehydrogenase (LDH) serum levels [ Time Frame: Day 7 ]To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
- Troponin serum levels [ Time Frame: Day 1 ]To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
- Troponin serum levels [ Time Frame: Day 3 ]To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
- Troponin serum levels [ Time Frame: Day 7 ]To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
- Electrolytes serum levels [ Time Frame: Day 1 ]To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
- Electrolytes serum levels [ Time Frame: Day 3 ]To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
- Electrolytes serum levels [ Time Frame: Day 7 ]To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
- Glucose serum levels [ Time Frame: Day 1 ]To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
- Glucose serum levels [ Time Frame: Day 3 ]To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
- Glucose serum levels [ Time Frame: Day 7 ]To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
- Renal function [ Time Frame: Day 1 ]To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
- Renal function [ Time Frame: Day 3 ]To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
- Renal function [ Time Frame: Day 7 ]To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
- Coagulogram [ Time Frame: Day 1 ]To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
- Coagulogram [ Time Frame: Day 3 ]To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
- Coagulogram [ Time Frame: Day 7 ]To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
- Liver function panel [ Time Frame: Day 1 ]To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
- Liver function panel [ Time Frame: Day 3 ]To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
- Liver function panel [ Time Frame: Day 7 ]To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
- Ferritin [ Time Frame: Day 1 ]To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
- Ferritin [ Time Frame: Day 3 ]To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
- Ferritin [ Time Frame: Day 7 ]To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
- D-dimer [ Time Frame: Day 1 ]To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
- D-dimer [ Time Frame: Day 3 ]To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
- D-dimer [ Time Frame: Day 7 ]To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
- Blood cell count [ Time Frame: 7 days ]To evaluate blood cell count of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, for 7 days; verified by laboratory tests and expressed by the absolute number between the two groups.
- Inflammatory mediators [ Time Frame: Day 1 ]To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
- Inflammatory mediators [ Time Frame: Day 3 ]To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
- Inflammatory mediators [ Time Frame: Day 7 ]To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
- Adverse events - percentage [ Time Frame: Day 14 ]Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by percentage.
- Adverse events - absolute number [ Time Frame: Day 14 ]Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by absolute number.
- Treatment discontinuation rate - absolute number [ Time Frame: Day 14 ]Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by absolute number.
- Treatment discontinuation rate - percentage [ Time Frame: Day 14 ]Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by percentage.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04561219
Brazil | |
Universidade Federal do Rio de Janeiro | |
Rio De Janeiro, Brazil, 21941902 |
Study Chair: | Pedro L Silva, PhD | Universidade Federal do Rio de Janeiro | |
Principal Investigator: | Patricia RM Rocco, MD, PhD | Universidade Federal do Rio de Janeiro |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jose Roberto Lapa e Silva, Clinical Investigator, Universidade Federal do Rio de Janeiro |
ClinicalTrials.gov Identifier: | NCT04561219 |
Other Study ID Numbers: |
SARITA-1 RBR-88bs9x ( Other Identifier: Registro Brasileiro de Ensaios Clínicos (REBEC) ) 30662420.0.1001.0008 ( Other Identifier: Comitê Nacional de Ética em Pesquisa (CONEP) ) |
First Posted: | September 23, 2020 Key Record Dates |
Last Update Posted: | July 22, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The investigators plan on sharing all IPD that underlie results in a publication for editorial board, with cautious of not sharing confidential data. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | Available as soon as the editorial board of the journal accepting the manuscript requires. |
Access Criteria: | Editorial board of the Journal accepting the manuscript. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
covid19 coronavirus clinical trial placebo-controlled randomized brazil nitazoxanide |
hospitalized patients covid-19 sars-cov-2 new coronavirus multicenter double-blind |
COVID-19 Pneumonia Coronavirus Infections Pneumonia, Viral Respiratory Tract Infections Infections Virus Diseases Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Nitazoxanide Antiparasitic Agents Anti-Infective Agents |