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

NCT05033145 | Completed Phase 3 DMC

• 1 other identifier: FNC IGZ-2
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 7

Brief Summary

Phase III, single-center with co-participating units, randomized, double-blind, parallel, placebo-controlled clinical study

Conditions

COVID-19

Keywords

AZVUDINE; SARS-CoV-2; COVID-19; FNC

Outcome Measures

Primary Outcomes (2)

• Proportion of patients hospitalized during the study through day 28

  WHO clinical progression ordinal scale (Jun/2020), Score 4 to 10.Health Organization Ordinal Clinical Progression Scale (WHO, Jun/2020; scale 0 \[asymptomatic\] to 10 \[death\]), with score 4 to 7.

  Day 14 to Day 30

• Proportion of participants with a clinical outcome of CURE during the study;

  The clinical outcome of cure is defined in this protocol as the absence of viral RNA in samples collected and clinical conditions for outpatient discharge.

  Day 14 to Day 30

Secondary Outcomes (13)

• Improvement in clinical status in at least one category compared to screening

  Day 14 to Day 30

• Severity and duration of symptoms: fever, cough, fatigue or tiredness, breathlessness, myalgia, nasal congestion or runny nose, sore throat, headache, chills, nausea, vomiting, anosmia, ageusia.

  Day 1 to Day 14

• Changes in kidney function

  Day 1 to Day 30

• Changes in liver function

  Day 1 to Day 30

• Time of use of AZVUDINE until the second negative conversion of RT-PCR

  Day 1 to Day 14

Study Arms (2)

AZVUDINE

EXPERIMENTAL

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

Drug: AZVUDINE

AZVUDINE placebo

PLACEBO COMPARATOR

Control: AZVUDINE placebo Intervention: AZVUDINE placebo tablet, 5 tablets QD + standard treatment, for up to 14 days

Drug: AZVUDINE placebo

Interventions

AZVUDINE DRUG

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

Also known as: 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

AZVUDINE

AZVUDINE placebo DRUG

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

Also known as: Placebo

AZVUDINE placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who present the following characteristics will be included in this study:
• Age ≥18 years, regardless of gender;
• Fluorescence RT-PCR test result of respiratory or blood samples must be positive for COVID-19, or viral gene sequencing of respiratory tract samples must be highly homologous to COVID-19; Individuals with COVID-19 must meet the diagnostic criteria in the "latest version of clinical guidelines for COVID-19" issued by the World Health Organization (WHO) on June 4, 2020;
• Symptomatic patients who meet the case definition for COVID-19, according to WHO, without evidence of bacterial pneumonia or hypoxia (Sat O2 \< 95%) P. \[score 1-3\];
• Voluntary participation and signing of the informed consent form.

You may not qualify if:

• Individuals who present one or more of the following characteristics will not be eligible to participate in this study:
• Know or suspect that you are allergic to any of the components of AZVUDINE tablets (inactive ingredients: microcrystalline cellulose, lactose hydrate, polyvinylpyrrolidone K30, croscarmellose sodium, magnesium stearate);
• Individual presenting shortness of breath and Sat O2 \< 95%; or any other symptom requiring treatment through hospital admission;
• Patients with liver disease (total bilirubin ≥2mg/dL, ALT/TGP e AST/TGO ≥5 times above normal limit);
• Pactients with a history of known liver disease (cirrhosis with ChildPugh classification B and C);
• Patients with a history of renal insufficiency (glomerular filtration rate \< 60mL/min/1,73m2);
• Patients with history of congestive heart failure (NYHA ¾ grade), untreated symptomatic arrhythmias ormyocardial infarction within 6 months;
• Individuals with malabsorption syndrome, or other conditions affecting gastrointestinal absorption, and circumstances in which patients require intravenous nutrition, or cannot take medications orally or nasogastrically;
• Total neutrophil count \<750 cells/L;

Sponsors & Collaborators

• HRH Pharmaceuticals Limited: lead
• GALZU INSTITUTE OF RESEARCH, TEACHING, SCIENCE AND APPLIED TECHNOLOGY, Brazil: collaborator
• Clinical Research Unit / High Complexity Center (CRU/HCC) / Galzu Institute: collaborator

Study Sites (7)

Hospital Moacyr Gomes de Azevedo

Cambuci, Rio de Janeiro, Brazil

Location

Clinical Research Unit / High Complexity Center (CRU/HCC) / Galzu Institute

Campos dos Goytacazes, Rio de Janeiro, 28110-000, Brazil

Location

Hospital Santa Casa de Misericórdia de Campos

Campos dos Goytacazes, Rio de Janeiro, Brazil

Location

Unidade de Pesquisa Clínica / Centro de Alta Complexidade

Campos dos Goytacazes, Rio de Janeiro, Brazil

Location

Unidade Pré Hospitalar São José

Campos dos Goytacazes, Rio de Janeiro, Brazil

Location

Hospital de Itaocara

Itaocara, Rio de Janeiro, Brazil

Location

Hospital Armando Vidal

São Fidelis, Rio de Janeiro, Brazil

Location

Related Publications (1)

• da Silva RM, Gebe Abreu Cabral P, de Souza SB, Arruda RF, Cabral SPF, de Assis ALEM, Martins YPM, Tavares CAA, Viana Junior AB, Chang J, Lei P. Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety in the treatment of mild cases of COVID-19. Front Med (Lausanne). 2023 Mar 14;10:1143485. doi: 10.3389/fmed.2023.1143485. eCollection 2023.

  PMID: 37007788 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

azvudine; Cytosine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sheila P Figueiredo, Nurse,MSc

  Galzu Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, parallel, placebo-controlled trial

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: September 2, 2021
• Study Start: January 15, 2022
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: August 12, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (7)