Phase III, Randomized, Double-blind, Placebo controlled trial of Efficacy, Safety and Tolerability of Antiviral drug Umifenovir vs Standard care of therapy in non-severe COVID-19 patients.

ABSTRACT:

Objective

To test efficacy, safety and tolerability of Umifenovir in non-severe COVID-19 adult patients.

Methods

We carried out randomized, double-blind, placebo-controlled, multicenter, phase III trials involving adult (18-75 years), non-severe COVID19 patients, randomized 1:1 on placebo or Umifenovir (800 mg BID, maximum 14 days) respectively along with standard-of-care. The primary endpoint for Asymptotic-mild patients was time to nasopharyngeal swab RT-PCR test negativity. For Moderate patients, the average change in the ordinal scale from the baseline scores on the eight-point WHO ordinal scale was assessed.

Results

132 patients were recruited between 3^rd October to 28^th April 2021, of which 9 discontinued due to various reasons. In Mild-asy

SUBMITTER: Ramachandran R 

PROVIDER: S-EPMC8603331 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature