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Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients

Primary Purpose

covid19

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Nitazoxanide
Placebo
Sponsored by
Azidus Brasil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for covid19

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Informed consent from patient or legal representative.
  • Subject of both genders (male and female not pregnant and not breastfeeding) aged over 49;
  • Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;

  • Symptomatic subject with symptoms for up to 72 hours who does not require hospitalization, with signs and symptoms of acute respiratory viral infection characterized by a feverish sensation or fever, which may or may not be present at the time of the examination (which may be reported to the health professional), accompanied by cough or sore throat or runny nose or difficulty breathing and:

    i) Oxygen saturation ≥ 90%; ii) Risk classification for COVID-19 between low (A) or medium (B) (scores 1 to 19), according to the Brazilian Ministry of Health.

Exclusion Criteria:

  • Participating in another RCT in the past 12 months;

  • Presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to:

    • HIV or HTLV virus infection;
    • Chronic hepatitis C (HCV) treated with direct antiviral drugs;
    • Liver failure;
    • Severe renal failure, including dialysis;
  • Present hypersensitivity to the study product (nitazoxanide), as well as to related compounds;
  • Concomitant administration of drugs that may interact with the product under study (nitazoxanide);
  • Participants who underwent treatment with other antiviral drugs;
  • Subject in antineoplastic treatment with chemotherapy or radiation therapy;
  • Subject with severe autoimmune diseases in immunosuppression;
  • Transplanted participants;
  • Pregnant or lactating women;
  • Any other clinical condition that is deemed by the Investigator to be an imminent risk to the health and life of the subject.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    nitazoxanide

    Placebo

    Arm Description

    Subjects will receive nitazonanide 600 mg TID.

    Subjects will receive placebo TID.

    Outcomes

    Primary Outcome Measures

    Change in signs and symptoms scale
    Symptoms will be assessed using a 5 point scale (1- excellent, 2- good, 3- fair, 4 - poor 5 - very poor).

    Secondary Outcome Measures

    Incidence of Treatment-Emergent Adverse Events
    Number of participants with treatment-related adverse events
    The proportion of subjects hospitalized after start of treatment and before the end of the study
    Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
    The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study
    Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
    Duration of symptoms
    Time required (days) to full symptom recovery
    Rate of mortality within 21-days
    Evaluation of change in acute respiratory syndrome

    Full Information

    First Posted
    June 18, 2020
    Last Updated
    October 26, 2022
    Sponsor
    Azidus Brasil
    Collaborators
    Farmoquimica S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04441398
    Brief Title
    Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients
    Official Title
    Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg to Treat Ambulatory Adult Subjects Diagnosed With COVID-19 With Mild Symptoms Assisted in the Public Health System of the City of Mesquita
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor's strategic decision
    Study Start Date
    July 2020 (Anticipated)
    Primary Completion Date
    September 2020 (Anticipated)
    Study Completion Date
    September 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Azidus Brasil
    Collaborators
    Farmoquimica S.A.

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.
    Detailed Description
    The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only. After 7 days of treatment, the Investigator can extend the treatment duration for another 7 days at his/her discretion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    covid19

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Subjects will be randomized to receive either nitazoxanide (n=150) or placebo (n=150)
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    nitazoxanide
    Arm Type
    Experimental
    Arm Description
    Subjects will receive nitazonanide 600 mg TID.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects will receive placebo TID.
    Intervention Type
    Drug
    Intervention Name(s)
    Nitazoxanide
    Other Intervention Name(s)
    Viranitta
    Intervention Description
    Subjects will receive nitazonanide 600 mg TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Subjects will receive placebo TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.
    Primary Outcome Measure Information:
    Title
    Change in signs and symptoms scale
    Description
    Symptoms will be assessed using a 5 point scale (1- excellent, 2- good, 3- fair, 4 - poor 5 - very poor).
    Time Frame
    21 days
    Secondary Outcome Measure Information:
    Title
    Incidence of Treatment-Emergent Adverse Events
    Description
    Number of participants with treatment-related adverse events
    Time Frame
    21 days
    Title
    The proportion of subjects hospitalized after start of treatment and before the end of the study
    Description
    Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
    Time Frame
    21 days
    Title
    The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study
    Description
    Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
    Time Frame
    21 days
    Title
    Duration of symptoms
    Description
    Time required (days) to full symptom recovery
    Time Frame
    21 days
    Title
    Rate of mortality within 21-days
    Description
    Evaluation of change in acute respiratory syndrome
    Time Frame
    21 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Informed consent from patient or legal representative. Subject of both genders (male and female not pregnant and not breastfeeding) aged over 49; Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; Symptomatic subject with symptoms for up to 72 hours who does not require hospitalization, with signs and symptoms of acute respiratory viral infection characterized by a feverish sensation or fever, which may or may not be present at the time of the examination (which may be reported to the health professional), accompanied by cough or sore throat or runny nose or difficulty breathing and: i) Oxygen saturation ≥ 90%; ii) Risk classification for COVID-19 between low (A) or medium (B) (scores 1 to 19), according to the Brazilian Ministry of Health. Exclusion Criteria: Participating in another RCT in the past 12 months; Presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to: HIV or HTLV virus infection; Chronic hepatitis C (HCV) treated with direct antiviral drugs; Liver failure; Severe renal failure, including dialysis; Present hypersensitivity to the study product (nitazoxanide), as well as to related compounds; Concomitant administration of drugs that may interact with the product under study (nitazoxanide); Participants who underwent treatment with other antiviral drugs; Subject in antineoplastic treatment with chemotherapy or radiation therapy; Subject with severe autoimmune diseases in immunosuppression; Transplanted participants; Pregnant or lactating women; Any other clinical condition that is deemed by the Investigator to be an imminent risk to the health and life of the subject.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edimilson Migowski, MD
    Organizational Affiliation
    NEPS SEMUS Mesquita
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.

    Learn more about this trial

    Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients

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