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Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected)

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ClinicalTrials.gov Identifier: NCT04668235
Recruitment Status : Not yet recruiting
First Posted : December 16, 2020
Last Update Posted : December 16, 2020
Sponsor:
Collaborators:
GALZU INSTITUTE OF RESEARCH, TEACHING, SCIENCE AND APPLIED TECHNOLOGY, Brazil
SANTA CASA DE MISERICORDIA DE CAMPOS HOSPITAL (SCMCH), Brazil
UNIVERSIDADE ESTADUAL DO NORTE FLUMINENSE (UENF), Brazil
Information provided by (Responsible Party):
HRH Holdngs Limited

Study Description
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Brief Summary:
Estimated number of participants: 342 participants with COVID-19 Design: Phase III, single-center, randomized, double-blind, parallel, placebo-controlled clinical study.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: AZVUDINE Drug: AZVUDINE placebo Phase 3

Detailed Description:

Hypothesis:

AZVUDINE has therapeutic potential and safety profile for the treatment of patients infected with SARS-CoV-2.

Goals:

Primary objective

- Assess the efficacy and safety of AZVUDINE in the treatment of COVID-19

Secondary objectives

  • Assess the effectiveness of AZVUDINE in improving patients infected with SARS-CoV-2
  • Assess the effect of AZVUDINE on COVID-19 progression
  • Assess the time for negative viral load conversion
  • Assess the frequency of serious adverse events during and after AZVUDINE treatment

Pharmaceutical form of the experimental medicine:

AZVUDINE 1 mg tablets

Comparators:

AZVUDINE placebo

Statistical planning:

The analyzes will be performed by FAS, PPS and SS and should be stratified by the severity of the disease (moderate, severe) and age (<60 years, ≥ 60 years), to assess the following parameters:

  • Progression of the disease (moderate to severe, severe type);
  • Negative viral load conversion rate;
  • Time of negative conversion of viral load;
  • Temperature recovery time;
  • Time taken to improve diarrhea, myalgia, fatigue and other symptoms;
  • Time to improve the pulmonary image;
  • Frequency of supplemental oxygenation or non-invasive ventilation;
  • Frequency of AEs;
  • Mortality rate.

All statistical tests will be bilateral tests. If the P value is ≤0.05, it is considered that there is statistical significance between the difference in the tests.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected): Phase III, Randomized, Double-blind, PLACEBO Controlled Trial
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm AZVUDINE

Experimental:

AZVUDINE 1mg tablet,

Interventions:

AZVUDINE 1mg tablet, 5 tablets QD + standard treatment for up to 14 days

 Drug: AZVUDINE
5 tablets QD + standard treatment for up to 14 days
Other Names:
  • AZVUDINE 1 mg tablets
  • FNC
  • 4-amino-1-((2R,3S,4R,5R)-5-azido-3-fluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidine-2(1H)-one
  • 1-(4-Azido-2-deoxy-2-fluoro-beta-D- arabino Ribo-furanosyl) cytosine, FNC
Placebo Comparator: Arm Placebo

Control:

AZVUDINE placebo,

Interventions:

AZVUDINE placebo, 5 tablets QD + standard treatment for up to 14 days

 Drug: AZVUDINE placebo
5 tablets QD + standard treatment for up to 14 days
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Negative conversion rate [ Time Frame: 7th day ]
    Negative conversion rate of coronavirus viral load on day 7 of treatment compared to baseline

  2. Negative conversion rate [ Time Frame: 14th day ]
    Negative conversion rate of coronavirus viral load on day 14 of treatment compared to baseline


Secondary Outcome Measures :
  1. Time of negative conversion [ Time Frame: 14th day ]
    Time of negative conversion of the viral load of the coronavirus

  2. Negative conversion rate [ Time Frame: on days 7, 14 and 28 ]
    Negative conversion rate of the coronavirus viral load on days 7, 14 and 28

  3. Recovery of body temperature [ Time Frame: 28th day ]
    Time of recovery of body temperature

  4. Improvement of respiratory signs and symptoms [ Time Frame: 28th day ]
    Time for improvement of respiratory signs and symptoms

  5. Improvement of diarrhea, myalgia fatigue and other symptoms [ Time Frame: 28th day ]
    Time for improvement of diarrhea, myalgia fatigue and other symptoms

  6. Change in blood oxygen detection rates [ Time Frame: 28th day ]
    Change in blood oxygen detection rates

  7. Frequency of supplemental oxygenation or non-invasive ventilation [ Time Frame: 14th day ]
    Frequency of supplemental oxygenation or non-invasive ventilation

  8. Frequency of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) [ Time Frame: 14th day ]
    Frequency of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)

  9. Frequency of adverse events [ Time Frame: 14th day ]
    Frequency of adverse events

  10. Frequency of serious adverse events [ Time Frame: 14th day ]
    Frequency of serious adverse events

  11. Proportion of moderate cases that progressed to severe cases [ Time Frame: 14th day ]
    Proportion of moderate cases that progressed to severe cases

  12. Proportion of severe cases that worsened during treatment [ Time Frame: 14th day ]
    Proportion of severe cases that worsened during treatment

  13. Mortality rate [ Time Frame: 28th day ]
    Mortality rate


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  1. Individuals aged 18 or over, regardless of gender;
  2. Patients hospitalized in moderate to severe stages in line with the Ministry of Health classification;
  3. Positive diagnosis for SARS-CoV-2 by molecular amplification of the virus in RT-PCR diagnosed from a respiratory sample (nasopharynx, oropharyngeal, lower respiratory tract [eg, sputum]) collected <96 hours before randomization;
  4. Time of onset of symptoms and inclusion ≤ 14 days;
  5. Internation within 48 hours after inclusion in the study;
  6. Follow-up availability during the study period;
  7. Voluntary membership to participate in the study and signing the Informed Consent Form.

Exclusion Criteria:

  1. Patients known or suspected of being sensitive to AZVUDINE or excipients (inactive ingredients: microcrystalline cellulose, hydrated lactose, polyvinylpyrrolidone K30, croscarmellose sodium, magnesium stearate);
  2. Patients diagnosed with pneumonia caused by other pathogens;
  3. Patients with liver disease (total bilirubin ≥2 times above the normal limit, ALT / TGP and AST / TGO ≥5 times above the normal limit)
  4. Patients with renal failure (glomerular filtration rate ≤60mL / min / 1.73 m2) or are receiving continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
  5. Individuals with malabsorption syndrome, or other conditions that affect gastrointestinal absorption, and circumstances in which patients need intravenous nutrition, or cannot take drugs orally or nasogastrically;
  6. Pregnant or lactating women, or women with the potential to become pregnant during the study period and within 6 months after the end of administration;
  7. Patients already included in other clinical trials;
  8. Patient under treatment for HIV;
  9. Patients being treated with other antivirals (eg lopinavir / ritonavir, remdesivir, umifenovir / arbidol, favipiravir, interferon-α)
  10. Patients undergoing treatment with monoclonal antibodies (eg tocilizumab and sarilumab / kevzara);
  11. Patients who are on a clinical treatment plan that includes the concomitant administration of any other experimental treatment or off-label use of drugs already on the market (eg hydroxychloroquine sulfate;
  12. Patients who require invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at the time of randomization;
  13. Any clinically significant medical condition or medical history that, in the investigator's opinion, might discourage participation in the study.
Contacts and Locations
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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): NCT04668235


Contacts
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Contact: Renato S Martins, MSc, PhD +55 22 99998 5248 rjrenato@icloud.com
Contact: Paula GA Cabral, MSc, PhD +55 22 98126 6602 pgacabral99@gmail.com

Locations
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Brazil
Santa Casa de Misericórdia de Campos
Campos Dos Goytacazes, RJ, Brazil
Contact: Paula GA Cabral, MSc, PhD    +55 22 98126 6602    pgacabral99@gmail.com   
Contact: Renato S Martins, MSc, PhD    +55 22 99998 5248    rjrenato@icloud.com   
Principal Investigator: Cleber G Silva, MD, MSc         
Sponsors and Collaborators
HRH Holdngs Limited
GALZU INSTITUTE OF RESEARCH, TEACHING, SCIENCE AND APPLIED TECHNOLOGY, Brazil
SANTA CASA DE MISERICORDIA DE CAMPOS HOSPITAL (SCMCH), Brazil
UNIVERSIDADE ESTADUAL DO NORTE FLUMINENSE (UENF), Brazil
Investigators
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Study Chair: George JM Mota, pharmacist Galzu Institute
More Information
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Responsible Party: HRH Holdngs Limited
ClinicalTrials.gov Identifier: NCT04668235    
Other Study ID Numbers: IGZ-1
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 HRH Holdngs Limited:
AZVUDINE
SARS-CoV-2
COVID-19
FNC