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

  • participants needed
  • sponsor
    HRH Pharmaceuticals Limited
Updated on 27 January 2022


Estimated number of participants: 342 participants with COVID-19 Design: Phase III, single-center, randomized, double-blind, parallel, placebo-controlled clinical study.



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


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


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

  • 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.

Condition *COVID-19, Covid-19
Treatment AZVUDINE, AZVUDINE placebo
Clinical Study IdentifierNCT04668235
SponsorHRH Pharmaceuticals Limited
Last Modified on27 January 2022

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