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

COVID-19 Clinical Trial

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

Status Completed

Clinical Trial Summary

Estimated number of participants: 342 participants with COVID-19 Design: Phase III, single-center, randomized, double-blind, parallel, placebo-controlled clinical study. In December 2021, there was a drop in the number of hospitalizations and the cases of COPD, tuberculosis and HIV associated with COVID-19, which are outside the inclusion criteria of this study. After the initial data of the study, there was a discussion with Anvisa and the size of the sample calculation was revised by amendment 4 (180 participants), and the methodology of statistical analysis for a new sample calculation was "a formula for sample calculation for superiority studies using proportions, according to the book do Chow et al (Chow, S.-C., Shao, J., Wang, H., &Lokhnygina, Y. Eds. 2017. Sample Size Calculations in Clinical Research: Third Edition, Chapman and Hall/CRC). Thus, Anvisa concluded that the adjustments are in accordance with the agency's guidelines, approving E4, which was later also approved by the Ethics Committee.

Clinical Trial Description

Hypothesis: AZVUDINE has therapeutic potential and safety profile for the treatment of patients infected with SARS-CoV-2. Goals: Primary objective • To assess the efficacy and safety of AZVUDINE (FNC) in relation to placebo, in patients infected with SARS-COV-2 in moderate to severe stage; Secondary objective • To evaluate the clinical outcome of the AZVUDINE group (FNC) compared to the placebo group in patients infected by SARS-COV-2 in moderate to severe stage; 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 necessary 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. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT04668235
• Study type: Interventional
• Source: HRH Pharmaceuticals Limited
• Status: Completed
• Phase: Phase 3
• Start date: April 23, 2021
• Completion date: August 10, 2022