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.
【초록키워드】 Efficacy, RT-PCR, Randomized, Nasopharyngeal swab, phase III trial, Patient, Placebo, multicenter, umifenovir, PCR test, moderate, patients, placebo-controlled, Ordinal Scale, RT-PCR test, primary endpoint, Safe, criteria, double-blind, Tolerability, secondary endpoint, dosage, average, WHO ordinal scale, COVID-19 adult patients, negativity, COVID19 patients, Standard-of-care, tested, carried, recruited, the WHO, statistically significant, exhibit, 1:1, baseline, meet, 【제목키워드】 therapy, Safety, Controlled trial, Care, phase, COVID-19 patient, Standard,