Among patients hospitalized with moderate to severe COVID-19, treatment with umifenovir in combination with other drugs did not significantly decrease time to clinical improvement (TTCI) or mortality, according to study results published in International Immunopharmacology.
In this single-center, open-label, randomized clinical trial (ClinicalTrials.gov identifier: NCT04350684) conducted in Tehran, Iran, researchers assessed the effectiveness of umifenovir in combination with other drugs for the treatment of patients hospitalized with moderate or severe COVID-19. Patients were randomly assigned in a 1:1 fashion to either the control group or intervention group. Patients in the control group received treatment with lopinavir/ritonavir (400 mg/100 mg) twice daily for 10 to 14 days in combination with a single dose of hydroxychloroquine (400 mg) and subcutaneous interferon-β1a (44 mcg
) on days 1, 3, and 5. The patients in the intervention group received the same treatment regimen as the control group with the addition of umifenovir (200 mg) 3 times daily for 7 days.
The primary outcome was TTCI based on 2-point improvement on a 7-category ordinal scale at day 21; secondary outcome was mortality at day 21.
The intention-to-treat analysis included 101 patients: 50 were in the control group and 51 were in the intervention group. At baseline, demographic and clinical characteristics were similar between the 2 groups. The mean patient age was 61.2 years, and 56.4% were men.
At day 21, TTCI did not significantly differ between the control and intervention groups (median, 7 days and 9 days, respectively; hazard ratio, 0.75; 95% CI, 0.45-1.23; P =.25). In-hospital mortality also was not statistically significantly different between the control and intervention groups (38.0% and 33.3%, respectively; P =.62).
In addition, there was no difference in mortality rates among patients who entered the study either 7 days prior vs 7 days after symptom onset, and the need for invasive mechanical ventilation was similar between the 2 groups.
With the exception of an increased risk for lymphopenia among patients in the control group, there were no significant safety differences between the 2 groups.
Because of increased concentrations of liver enzymes, 20 patients in the control group and 18 in the intervention group were unable to complete the treatment course.
Umifenovir in combination with other drugs was not “effective in shortening the duration of SARS-CoV-2 in severe patients” or “improving the prognosis in non-[intensive care unit] patients,” the researchers concluded.
Darazam IA, Shokouhi S, Mardani M, et al. Umifenovir in hospitalized moderate to severe COVID-19 patients: A randomized clinical trial. Int Immunopharmacol. 2021;99:107969. doi:10.1016/j.intimp.2021.107969