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.

Autor:	Ramachandran R; CSIR-Central Drug Research Institute, Lucknow. Electronic address: r_ravishankar@cdri.res.in., Bhosale V; CSIR-Central Drug Research Institute, Lucknow., Reddy H; King George's Medical University, Lucknow., Atam V; King George's Medical University, Lucknow., Faridi M; ERA's Lucknow Medical College and Hospital., Fatima J; ERA's Lucknow Medical College and Hospital., Shukla V; ERA's Lucknow Medical College and Hospital., Khan ZA; ERA's Lucknow Medical College and Hospital., Khan H; ERA's Lucknow Medical College and Hospital., Singh V; Ram Manohar Lohia Institute of Medical Sciences, Lucknow., Negi MPS; CSIR-Central Drug Research Institute, Lucknow., Srivastava M; CSIR-Central Drug Research Institute, Lucknow., Srivastava AK; CSIR-Central Drug Research Institute, Lucknow., Tripathi CB; CSIR-Central Drug Research Institute, Lucknow., Ghosh N; CSIR-Central Drug Research Institute, Lucknow., Majumdar N; CSIR-Central Drug Research Institute, Lucknow., Tripathi RK; CSIR-Central Drug Research Institute, Lucknow., Rath SK; CSIR-Central Drug Research Institute, Lucknow., Mishra PR; CSIR-Central Drug Research Institute, Lucknow., Sharma S; CSIR-Central Drug Research Institute, Lucknow., Kundu TK; CSIR-Central Drug Research Institute, Lucknow. Electronic address: director@cdri.res.in.
Jazyk:	angličtina
Zdroj:	International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases [Int J Infect Dis] 2022 Feb; Vol. 115, pp. 62-69. Date of Electronic Publication: 2021 Nov 19.
DOI:	10.1016/j.ijid.2021.11.025
Abstrakt:	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. (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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