Nitazoxanide Therapy for Patients With COVID-19 Pneumonia

Sponsor
Universidade Federal do Rio de Janeiro (Other)
Overall Status
Completed
CT.gov ID
NCT04561219
Collaborator
Ministry of Science and Technology, Brazil (Other), National Research Council, Brazil (Other), Financiadora de Estudos e Projetos (Other), ATCGen (Other), Hospital Central da Aeronáutica, Rio de Janeiro (Other), Hospital da Força Aérea do Galeão (Other), Hospital Naval Marcilio Dias (Other), Hospital Universitario Pedro Ernesto (Other), Hospital de Força Aérea de São Paulo (Other), Hospital das Clínicas Luzia de Pinho Melo (Other), Complexo Hospitalar Municipal de São Caetano do Sul (Other), Hospital Municipal de Barueri Dr Francisco Moran (Other), Hospital Regional de Sorocaba Dr Adib Domingos Jatene (Other), Hospital Geral de São Mateus Dr Manoel Bifulco (Other), Santa Casa de Misericórdia de Belo Horizonte (Other), Mater Dei Hospital, Brazil (Other), Hospital Eduardo de Menezes (Other), Hospital das Clínicas da Universidade Federal de Pernambuco (Other), Hospital das Forças Armadas, Brazil (Other), Hospital Regional da Asa Norte, Brazil (Other), Complexo Hospitalar do Trabalhador de Curitiba (Other), Hospital Estadual de Doenças Tropicais Dr Anuar Auad (Other), Hospital Geral de Fortaleza (Other)
500
1
2
5.5
91.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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),

Study Design

Study Type:
Interventional
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.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 :
Apr 19, 2020
Actual Primary Completion Date :
Oct 2, 2020
Actual Study Completion Date :
Oct 2, 2020

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Orotracheal intubation rate [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.

    Secondary Outcome Measures

    1. Hospitalisation days [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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
    • 30662420.0.1001.0008
    First Posted:
    Sep 23, 2020
    Last Update Posted:
    Jul 22, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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, Clinical Investigator, Universidade Federal do Rio de Janeiro
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 22, 2021