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Nitazoxanide Therapy for Patients With COVID-19 Pneumonia

Primary Purpose

Covid19, Corona Virus Infection, Pneumonia, Viral

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Nitazoxanide
Placebo
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid19, coronavirus, clinical trial, placebo-controlled, randomized, brazil, nitazoxanide, hospitalized patients, covid-19, sars-cov-2, new coronavirus, multicenter, double-blind

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidade Federal do Rio de Janeiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nitazoxanide

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Orotracheal intubation rate
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.

Secondary Outcome Measures

Hospitalisation 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
September 22, 2020
Last Updated
July 15, 2021
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Ministry 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
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1. Study Identification

Unique Protocol Identification Number
NCT04561219
Brief Title
Nitazoxanide Therapy for Patients With COVID-19 Pneumonia
Official Title
Nitazoxanide for Moderate to Severe COVID-19 Pneumonia: a Multicenter, Randomized, Placebo-controlled, Double-Blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 19, 2020 (Actual)
Primary Completion Date
October 2, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Ministry 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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),

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Corona Virus Infection, Pneumonia, Viral
Keywords
covid19, coronavirus, clinical trial, placebo-controlled, randomized, brazil, nitazoxanide, hospitalized patients, covid-19, sars-cov-2, new coronavirus, multicenter, double-blind

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare 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.
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitazoxanide
Arm Type
Experimental
Arm Description
Patients received nitazoxanide 500mg 8/8hours, for 5 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients received placebo 500mg 8/8hours, for 5 days
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
annita, azox, irose, tanisea, trinida, zoxany
Intervention Description
Nitazoxanide 500mg three times a day for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo three times a day for 5 days
Primary Outcome Measure Information:
Title
Orotracheal intubation rate
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Hospitalisation days
Description
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.
Time Frame
14 days
Title
ICU days
Description
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.
Time Frame
14 days
Title
Intranasal oxygen support days
Description
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.
Time Frame
14 days
Title
Mortality rate
Description
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.
Time Frame
14 days
Title
Days with fever
Description
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.
Time Frame
14 days
Title
Days with cough
Description
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.
Time Frame
14 days
Title
Days with dyspnea
Description
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.
Time Frame
14 days
Title
Radiologic findings
Description
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.
Time Frame
Day1
Title
Radiologic findings
Description
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.
Time Frame
Day7
Title
Cardiologic findings
Description
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.
Time Frame
Day1
Title
Cardiologic findings
Description
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.
Time Frame
Day7
Title
C-reactive protein - absolute number
Description
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.
Time Frame
Day 1
Title
C-reactive protein serum levels
Description
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.
Time Frame
Day 3
Title
C-reactive protein serum levels
Description
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.
Time Frame
Day 7
Title
Lactate dehydrogenase (LDH) serum levels
Description
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.
Time Frame
Day 1
Title
Lactate dehydrogenase (LDH) serum levels
Description
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.
Time Frame
Day 3
Title
Lactate dehydrogenase (LDH) serum levels
Description
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.
Time Frame
Day 7
Title
Troponin serum levels
Description
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.
Time Frame
Day 1
Title
Troponin serum levels
Description
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.
Time Frame
Day 3
Title
Troponin serum levels
Description
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.
Time Frame
Day 7
Title
Electrolytes serum levels
Description
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.
Time Frame
Day 1
Title
Electrolytes serum levels
Description
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.
Time Frame
Day 3
Title
Electrolytes serum levels
Description
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.
Time Frame
Day 7
Title
Glucose serum levels
Description
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.
Time Frame
Day 1
Title
Glucose serum levels
Description
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.
Time Frame
Day 3
Title
Glucose serum levels
Description
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.
Time Frame
Day 7
Title
Renal function
Description
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.
Time Frame
Day 1
Title
Renal function
Description
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.
Time Frame
Day 3
Title
Renal function
Description
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.
Time Frame
Day 7
Title
Coagulogram
Description
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.
Time Frame
Day 1
Title
Coagulogram
Description
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.
Time Frame
Day 3
Title
Coagulogram
Description
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.
Time Frame
Day 7
Title
Liver function panel
Description
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.
Time Frame
Day 1
Title
Liver function panel
Description
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.
Time Frame
Day 3
Title
Liver function panel
Description
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.
Time Frame
Day 7
Title
Ferritin
Description
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.
Time Frame
Day 1
Title
Ferritin
Description
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.
Time Frame
Day 3
Title
Ferritin
Description
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.
Time Frame
Day 7
Title
D-dimer
Description
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.
Time Frame
Day 1
Title
D-dimer
Description
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.
Time Frame
Day 3
Title
D-dimer
Description
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.
Time Frame
Day 7
Title
Blood cell count
Description
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.
Time Frame
7 days
Title
Inflammatory mediators
Description
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.
Time Frame
Day 1
Title
Inflammatory mediators
Description
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.
Time Frame
Day 3
Title
Inflammatory mediators
Description
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.
Time Frame
Day 7
Other Pre-specified Outcome Measures:
Title
Adverse events - percentage
Description
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.
Time Frame
Day 14
Title
Adverse events - absolute number
Description
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.
Time Frame
Day 14
Title
Treatment discontinuation rate - absolute number
Description
Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by absolute number.
Time Frame
Day 14
Title
Treatment discontinuation rate - percentage
Description
Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by percentage.
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro L Silva, PhD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patricia RM Rocco, MD, PhD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio de Janeiro
City
Rio De Janeiro
ZIP/Postal Code
21941902
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Available as soon as the editorial board of the journal accepting the manuscript requires.
IPD Sharing Access Criteria
Editorial board of the Journal accepting the manuscript.
Citations:
PubMed Identifier
27095301
Citation
Rossignol JF. Nitazoxanide, a new drug candidate for the treatment of Middle East respiratory syndrome coronavirus. J Infect Public Health. 2016 May-Jun;9(3):227-30. doi: 10.1016/j.jiph.2016.04.001. Epub 2016 Apr 16.
Results Reference
background
PubMed Identifier
25108173
Citation
Rossignol JF. Nitazoxanide: a first-in-class broad-spectrum antiviral agent. Antiviral Res. 2014 Oct;110:94-103. doi: 10.1016/j.antiviral.2014.07.014. Epub 2014 Aug 7.
Results Reference
background
PubMed Identifier
32511548
Citation
Rajoli RK, Pertinez H, Arshad U, Box H, Tatham L, Curley P, Neary M, Sharp J, Liptrott NJ, Valentijn A, David C, Rannard SP, Aljayyoussi G, Pennington SH, Hill A, Boffito M, Ward SA, Khoo SH, Bray PG, O'Neill PM, Hong WD, Biagini G, Owen A. Dose prediction for repurposing nitazoxanide in SARS-CoV-2 treatment or chemoprophylaxis. medRxiv. 2020 May 6:2020.05.01.20087130. doi: 10.1101/2020.05.01.20087130. Preprint.
Results Reference
background
PubMed Identifier
32405422
Citation
Pepperrell T, Pilkington V, Owen A, Wang J, Hill AM. Review of safety and minimum pricing of nitazoxanide for potential treatment of COVID-19. J Virus Erad. 2020 Apr 30;6(2):52-60. doi: 10.1016/S2055-6640(20)30017-0.
Results Reference
background
PubMed Identifier
35492335
Citation
Rocco PRM, Silva PL, Cruz FF, Tierno PFGMM, Rabello E, Junior JC, Haag F, de Avila RE, da Silva JDG, Mamede MMS, Buchele KS, Barbosa LCV, Cabral AC, Junqueira AAF, Araujo-Filho JA, da Costa LATJ, Alvarenga PPM, Moura AS, Carajeleascow R, de Oliveira MC, Silva RGF, Soares CRP, Fernandes APSM, Fonseca FG, Camargos VN, Reis JS, Franchini KG, Luiz RR, Morais S, Sverdloff C, Martins CM, Felix NS, Mattos-Silva P, Nogueira CMB, Caldeira DAF, Pelosi P, Lapa-E-Silva JR. Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. Front Med (Lausanne). 2022 Apr 13;9:844728. doi: 10.3389/fmed.2022.844728. eCollection 2022.
Results Reference
derived

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Nitazoxanide Therapy for Patients With COVID-19 Pneumonia

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