Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04668235
Status:
COMPLETED
Last Update Posted:
2022-08-12
First Post:
2020-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected)
Sponsor:
HRH Pharmaceuticals Limited
Organization:
Study Overview
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
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: