Dataset Information

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-asymptomatic patients (n=82), we found that 73% patients in the Umifenovir arm were RT-PCR negative, while 40% patients in the placebo arm were negative (P=0.004) on day 5. However, in the moderate group (n=41), the WHO scores for the Umifenovir arm was not statistically significant (P=0.125 on day 3), while it was statistically significant in the Mild-asymptomatic group (P=0.019 on day 5).

Conclusion

Umifenovir meets the primary and secondary endpoint criteria and exhibits statistically significant efficacy for Mild-asymptomatic patients. It is efficacious, safe and well-tolerated at the tested dosage of 800mg BID, maximum 14 days.

SUBMITTER: Ramachandran R

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

REPOSITORIES: biostudies-literature

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Publications

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.

Ramachandran Ravishankar R Bhosale Vivek V Reddy Himanshu H Atam Virendra V Faridi Mma M Fatima Jalees J Shukla Vaibhav V Khan Zaw A ZA Khan Hana H Singh Vikram V Negi Mahendra Pal Singh MPS Srivastava Mukesh M Srivastava Ajay Kumar AK Tripathi Chandra Bhushan CB Ghosh Nayan N Majumdar Nilanjana N Tripathi Raj Kamal RK Rath Srikanta Kumar SK Mishra Prabhat Ranjan PR Sharma Sharad S Kundu Tapas K TK

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases 20211119

<h4>Objective</h4>To test efficacy, safety and tolerability of Umifenovir in non-severe COVID-19 adult patients.<h4>Methods</h4>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 ...[more]

PMID: 34801738

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Dataset Information

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.

Objective

Methods

Results

Conclusion

Publications

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.

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