Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT04668235
Brief 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.
Detailed 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.
Study:
NCT04668235
Study Brief:
Protocol Section:
NCT04668235