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

  • STATUS
    Recruiting
  • participants needed
    342
  • sponsor
    HRH Pharmaceuticals Limited
Updated on 27 January 2022

Summary

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

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.

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

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note