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Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19

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Withdrawn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 prevention trial for covid19

Eligibility Criteria

18 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 18 years or over;
  • Subject that lives in a vulnerable community;
  • Subject that were in direct contact with confirmed cases of SARS-CoV-2 infection, as they live or work directly with index patients;
  • Not showing symptoms compatible with COVID-19 and and that do not have a positive RT-PCR test in a nasopharyngeal swab sample before randomization;
  • Participant capable of understanding and fulfilling all activities planned for the study;
  • In use of an acceptable method of contraception throughout the study.

Exclusion Criteria:

  • Participating in another RCT in the past 12 months;
  • Positive PCR result for COVID-19 during screening;
  • History of infection confirmed by SARS-CoV-2;
  • Present symptoms suggestive of SARS-CoV-2 infection;

  • 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 antivirals and / or antiparasitic drugs in the last 30 days;
  • 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

    The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
    PCR will be done to evaluate infection

    Secondary Outcome Measures

    Incidence of Treatment-Emergent Adverse Events
    Number of participants with treatment-related adverse events
    The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
    Symptomatic PCR positive subjects
    The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study
    Asymptomatic PCR will be done to evaluate infection
    Treatment adherence
    Subject adherence to treatment will be assessed through study diary record
    Disease complication
    Proportion of patients with severe condition
    Incidence of subjects that underwent unscheduled visit
    Proportion of patient that needed undergo an unscheduled visit

    Full Information

    First Posted
    June 8, 2020
    Last Updated
    October 26, 2022
    Sponsor
    Azidus Brasil
    Collaborators
    Farmoquimica S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04435314
    Brief Title
    Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19
    Official Title
    Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg Three Times a Day for Post Exposure Prophylaxis of COVID-19 in Subjects From Vulnerable Communities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor's strategic decision
    Study Start Date
    June 2020 (Anticipated)
    Primary Completion Date
    August 2020 (Anticipated)
    Study Completion Date
    August 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 primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease.
    Detailed Description
    The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease. Subjects that PCR is negative after having direct contact with symptomatic subjects and diagnosed with COVID-19 (PCR positive) will be randomized to receive Nitazoxanide TID or placebo TID for 7 days.

    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
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Subjects will be randomized to receive either nitazoxanide (n=100) or placebo (n=100)
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Subjects will receive placebo TID for 7 days.
    Primary Outcome Measure Information:
    Title
    The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
    Description
    PCR will be done to evaluate infection
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Incidence of Treatment-Emergent Adverse Events
    Description
    Number of participants with treatment-related adverse events
    Time Frame
    28 days
    Title
    The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
    Description
    Symptomatic PCR positive subjects
    Time Frame
    28 days
    Title
    The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study
    Description
    Asymptomatic PCR will be done to evaluate infection
    Time Frame
    28 days
    Title
    Treatment adherence
    Description
    Subject adherence to treatment will be assessed through study diary record
    Time Frame
    7 days
    Title
    Disease complication
    Description
    Proportion of patients with severe condition
    Time Frame
    28 days
    Title
    Incidence of subjects that underwent unscheduled visit
    Description
    Proportion of patient that needed undergo an unscheduled visit
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 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 18 years or over; Subject that lives in a vulnerable community; Subject that were in direct contact with confirmed cases of SARS-CoV-2 infection, as they live or work directly with index patients; Not showing symptoms compatible with COVID-19 and and that do not have a positive RT-PCR test in a nasopharyngeal swab sample before randomization; Participant capable of understanding and fulfilling all activities planned for the study; In use of an acceptable method of contraception throughout the study. Exclusion Criteria: Participating in another RCT in the past 12 months; Positive PCR result for COVID-19 during screening; History of infection confirmed by SARS-CoV-2; Present symptoms suggestive of SARS-CoV-2 infection; 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 antivirals and / or antiparasitic drugs in the last 30 days; 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
    Reginaldo Raimundo Fujita
    Organizational Affiliation
    Federal University of São Paulo
    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 for Post Exposure Prophylaxis of COVID-19

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