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

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

Evaluation of the Safety and Clinical Efficacy of AZVUDINE: Randomized, Double-blind, Placebo-controlled Study in Mild Stage Patients Infected With the SARS-CoV-2 Virus

NCT05033145•HRH Pharmaceuticals Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;

Locations (7)

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

Key Dates

Start Date

January 15, 2022

Primary Completion Date

July 27, 2022

Completion Date

July 27, 2022

Last Updated

August 12, 2022

Enrollment

312

ACTUAL participants

Conditions

COVID-19

Interventions

AZVUDINE

DRUG

AZVUDINE placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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