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Nitazoxanide Therapy for Patients With COVID-19 Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04561219
Recruitment Status : Completed
First Posted : September 23, 2020
Last Update Posted : October 28, 2020
Sponsor:
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
Information provided by (Responsible Party):
Jose Roberto Lapa e Silva, Universidade Federal do Rio de Janeiro

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.


Condition or disease Intervention/treatment Phase
Covid19 Corona Virus Infection Pneumonia, Viral Drug: Nitazoxanide Drug: Placebo Phase 2

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),

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Nitazoxanide
Patients received nitazoxanide 500mg 8/8hours, for 5 days.
Drug: Nitazoxanide
Nitazoxanide 500mg three times a day for 5 days
Other Names:
  • annita
  • azox
  • irose
  • tanisea
  • trinida
  • zoxany

Placebo Comparator: Placebo
Patients received placebo 500mg 8/8hours, for 5 days
Drug: Placebo
Placebo three times a day for 5 days




Primary Outcome Measures :
  1. 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.

  2. Mechanical ventilation free 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 free of mechanical ventilation, in the period of 14 days; verified by clinical evolution; quantified by absolute number.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Clinical scenario compatible with infection by the SARS-CoV-2 [Characteristic symptoms of COVID-19 (fever and / or cough) without respiratory failure (Saturation < 93% with nasal catheter of oxygen 5liters/minute) associated with chest tomographic images compatible with COVID-19.
  • Clinical scenario compatible with infection by the SARS-CoV-2 [Characteristic symptoms of COVID-19 (fever and / or cough) without respiratory failure (Saturation < 93% with nasal catheter of oxygen 5liters/minute) associated with positive molecular test for COVID-19.
  • 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

Information from the National Library of Medicine

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


Locations
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Brazil
Universidade Federal do Rio de Janeiro
Rio De Janeiro, Brazil, 21941902
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
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
Investigators
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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:
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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: October 28, 2020
Last Verified: October 2020
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Roberto Lapa e Silva, Universidade Federal do Rio de Janeiro:
covid19
coronavirus
clinical trial
placebo-controlled
randomized
brazil
nitazoxanide
hospitalized patients
covid-19
sars-cov-2
new coronavirus
multicenter
double-blind
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents