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A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）

Primary Purpose

COVID-19

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FNC+Standard of Care
FNC dummy tablet+Standard of Care
Sponsored by
HeNan Sincere Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age ≥18 years old, gender not limited;
  2. Laboratory (RT-PCR) confirmed COVID-19;
  3. the time from the first positive nucleic acid test to randomization does not exceed more than 4 days;
  4. informed consent has been signed.

Exclusion Criteria:

  1. known or suspected allergies to the components of azivudine tablets;
  2. according to the latest version of the National Health and Medical Commission Diagnostic criteria of COVID-19, patients with severe novel coronavirus pneumonia was confirmed;
  3. severe liver disease (TBIL>=2 times normal upper limit; ALTAST>=5 times normal upper limit);
  4. subjects with severe renal insufficiency (glomerular filtration rate ≤60 mL/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
  5. subjects with complication of malabsorption syndrome or any other condition affecting gastrointestinal absorption, requiring intravenous nutrition or not being able to take drugs orally;
  6. subjectsis currently receiving anti-hiv treatment;
  7. women who are breast-feeding during pregnancy or have a family plan during the trial period and within 6 months after the end of the trial;
  8. participating in other clinical trials or using experimental drugs, except traditional Chinese medicine;
  9. Other conditions that not appropriate to be enrolled into this study based on investigator's advise.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental Group

    Control Group

    Arm Description

    FNC+Standard of Care

    FNC dummy tablet+ Standard of Care

    Outcomes

    Primary Outcome Measures

    Change (reduction) in viral load from baseline
    (reduction) in viral load from baseline

    Secondary Outcome Measures

    proportion of subjects change from mild or moderate type to severe type
    proportion of subjects change from mild or moderate type to severe type
    proportion of subjects change from severe type to critical type
    proportion of subjects change from severe type to critical type
    novel coronavirus nucleic acid conversion rate
    novel coronavirus nucleic acid conversion rate
    Novel coronavirus nucleic acid negative conversion time
    Novel coronavirus nucleic acid negative conversion time
    The time and proportion of improvement in pulmonary imaging
    TIme(Days);Proportion(percent)
    Time and proportion of temperature return to normal
    TIme(Days);Proportion(percent)
    time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.)
    TIme(Days);Proportion(percent)
    time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms
    TIme(Days);Proportion(percent)
    Changes of blood oxygen detection index
    Changes of blood oxygen detection index
    Frequency of requirement for supplemental oxygen or non-invasive ventilation
    Frequency of requirement for supplemental oxygen or non-invasive ventilation
    Frequency of adverse events
    Frequency of adverse events

    Full Information

    First Posted
    May 9, 2020
    Last Updated
    June 8, 2020
    Sponsor
    HeNan Sincere Biotech Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04425772
    Brief Title
    A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）
    Official Title
    A Randomized,Double Blinded, Double Dummy, Parallel Controlled Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 12, 2020 (Anticipated)
    Primary Completion Date
    August 12, 2020 (Anticipated)
    Study Completion Date
    August 12, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    HeNan Sincere Biotech Co., Ltd

    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
    To evaluate the efficacy and safety of azvudine in treatment of COVID-19

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    342 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    FNC+Standard of Care
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    FNC dummy tablet+ Standard of Care
    Intervention Type
    Drug
    Intervention Name(s)
    FNC+Standard of Care
    Other Intervention Name(s)
    Azvudine+SOC
    Intervention Description
    FNC + Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria
    Intervention Type
    Drug
    Intervention Name(s)
    FNC dummy tablet+Standard of Care
    Other Intervention Name(s)
    Azvudin dummy tablet+SOC
    Intervention Description
    FNC dummy tablet+ Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria
    Primary Outcome Measure Information:
    Title
    Change (reduction) in viral load from baseline
    Description
    (reduction) in viral load from baseline
    Time Frame
    On day 7 and 14
    Secondary Outcome Measure Information:
    Title
    proportion of subjects change from mild or moderate type to severe type
    Description
    proportion of subjects change from mild or moderate type to severe type
    Time Frame
    up to 21 days
    Title
    proportion of subjects change from severe type to critical type
    Description
    proportion of subjects change from severe type to critical type
    Time Frame
    up to 21 days
    Title
    novel coronavirus nucleic acid conversion rate
    Description
    novel coronavirus nucleic acid conversion rate
    Time Frame
    up to 21 days
    Title
    Novel coronavirus nucleic acid negative conversion time
    Description
    Novel coronavirus nucleic acid negative conversion time
    Time Frame
    up to 21 days
    Title
    The time and proportion of improvement in pulmonary imaging
    Description
    TIme(Days);Proportion(percent)
    Time Frame
    up to 21 days
    Title
    Time and proportion of temperature return to normal
    Description
    TIme(Days);Proportion(percent)
    Time Frame
    up to 21 days
    Title
    time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.)
    Description
    TIme(Days);Proportion(percent)
    Time Frame
    up to 21 days
    Title
    time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms
    Description
    TIme(Days);Proportion(percent)
    Time Frame
    up to 21 days
    Title
    Changes of blood oxygen detection index
    Description
    Changes of blood oxygen detection index
    Time Frame
    up to 21 days
    Title
    Frequency of requirement for supplemental oxygen or non-invasive ventilation
    Description
    Frequency of requirement for supplemental oxygen or non-invasive ventilation
    Time Frame
    up to 21 days
    Title
    Frequency of adverse events
    Description
    Frequency of adverse events
    Time Frame
    up to 21 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age ≥18 years old, gender not limited; Laboratory (RT-PCR) confirmed COVID-19; the time from the first positive nucleic acid test to randomization does not exceed more than 4 days; informed consent has been signed. Exclusion Criteria: known or suspected allergies to the components of azivudine tablets; according to the latest version of the National Health and Medical Commission Diagnostic criteria of COVID-19, patients with severe novel coronavirus pneumonia was confirmed; severe liver disease (TBIL>=2 times normal upper limit; ALTAST>=5 times normal upper limit); subjects with severe renal insufficiency (glomerular filtration rate ≤60 mL/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal dialysis; subjects with complication of malabsorption syndrome or any other condition affecting gastrointestinal absorption, requiring intravenous nutrition or not being able to take drugs orally; subjectsis currently receiving anti-hiv treatment; women who are breast-feeding during pregnancy or have a family plan during the trial period and within 6 months after the end of the trial; participating in other clinical trials or using experimental drugs, except traditional Chinese medicine; Other conditions that not appropriate to be enrolled into this study based on investigator's advise.

    12. IPD Sharing Statement

    Learn more about this trial

    A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）

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