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

NCT ID: NCT05033145

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2022-07-27

Brief Summary

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

Detailed Description

Hypothesis:

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

Goals:

Main goal:

To evaluate the efficacy and safety of AZVUDINE (FNC) in patients infected with SARS-COV-2, in a mild stage;

Specific objective:

To assess the clinical outcome of mild-stage SARS-CoV-2 infected participants treated with AZVUDINE (FNC) versus placebo

Statistical planning:

Statistical description: all statistical tests are performed by bilateral testing. A significance level of 5% will be adopted.

Baseline analysis: including subject distribution, data demographics, and baseline analysis.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AZVUDINE

Experimental:

AZVUDINE 1mg tablet

Interventions:

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

Group Type: EXPERIMENTAL

AZVUDINE

Intervention Type: DRUG

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

AZVUDINE placebo

Control:

AZVUDINE placebo

Intervention:

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

Group Type: PLACEBO_COMPARATOR

AZVUDINE placebo

Intervention Type: DRUG

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

Interventions

AZVUDINE

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

Intervention Type: DRUG

AZVUDINE placebo

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

Intervention Type: DRUG

Other Intervention 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

Eligibility Criteria

Inclusion Criteria

Individuals who present the following characteristics will be included in this study:

1. Age ≥18 years, regardless of gender;

2. 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;

3. 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];

4. Voluntary participation and signing of the informed consent form.

Exclusion Criteria

Individuals who present one or more of the following characteristics will not be eligible to participate in this study:

1. 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);

2. Individual presenting shortness of breath and Sat O2 < 95%; or any other symptom requiring treatment through hospital admission;

3. Patients with liver disease (total bilirubin ≥2mg/dL, ALT/TGP e AST/TGO ≥5 times above normal limit);

4. Pactients with a history of known liver disease (cirrhosis with ChildPugh classification B and C);

5. Patients with a history of renal insufficiency (glomerular filtration rate < 60mL/min/1,73m2);

6. Patients with history of congestive heart failure (NYHA ¾ grade), untreated symptomatic arrhythmias ormyocardial infarction within 6 months;

7. 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;

8. Total neutrophil count <750 cells/L;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GALZU INSTITUTE OF RESEARCH, TEACHING, SCIENCE AND APPLIED TECHNOLOGY, Brazil

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

HRH Pharmaceuticals Limited

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheila P Figueiredo, Nurse,MSc

Role: STUDY_CHAIR

Galzu Institute

Locations

Hospital Moacyr Gomes de Azevedo

Cambuci, Rio de Janeiro, Brazil

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

Campos dos Goytacazes, Rio de Janeiro, Brazil

Hospital Santa Casa de Misericórdia de Campos

Campos dos Goytacazes, Rio de Janeiro, Brazil

Unidade de Pesquisa Clínica / Centro de Alta Complexidade

Campos dos Goytacazes, Rio de Janeiro, Brazil

Unidade Pré Hospitalar São José

Campos dos Goytacazes, Rio de Janeiro, Brazil

Hospital de Itaocara

Itaocara, Rio de Janeiro, Brazil

Hospital Armando Vidal

São Fidelis, Rio de Janeiro, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 37007788 (View on PubMed)

Other Identifiers

FNC IGZ-2

Identifier Type: -

Identifier Source: org_study_id